Kidney/Renal Cancer

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Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing


Condition: Carcinoma, Renal Cell

Intervention:

  • Drug: Sunitinib
  • Drug: Sunitinib

Purpose: The purpose of this study is to determine the effect of a sunitinib administration schedule 2/1 (2 weeks of treatment followed by 1 week without) compared to a schedule 4/2 (4 weeks of treatment followed by 2 weeks without) on cardiopulmonary function in subjects with renal cell carcinoma. Subjects will be randomized 1:1 to one of two arms: 4/2 schedule of sunitinib administration or 2/1 schedule of sunitinib administration. Cardiopulmonary function will be assessed at baseline, week 4 (4/2 schedule only), week 5 (2/1 schedule only) and week 12. The investigators hypothesize that schedule 2/1 of sunitinib is not only better tolerated but will be associated with less fatigue and functional cardiovascular/muscular toxicity than the 4/2 schedule.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03109015

Sponsor: Duke University

Primary Outcome Measures:

  • Measure: Change in VO2 peak from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Change in difference between Rest and Stress Left Ventricular Ejection Fraction (LVEF) and Cardiac Function by 2-D echocardiography (2DE) from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in difference between Rest and Stress Left Ventricular Ejection Fraction (LVEF) and Cardiac Function by 3-D echocardiography (3DE) from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in one repetition maximum (1RM) in upper and lower extremity muscular strength from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in Muscular Endurance in upper and lower extremity muscular strength from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in Muscle cross-sectional area (CSA) of the major muscles near Lumbar3 (CT scans and Slice-O-Matic® software) from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in time taken to complete the 5-repititionChair-stand test from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in time taken to complete the Timed up and Go test from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in distance walked during the 6 minute walk test from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale score from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in Functional Assessment of Cancer Therapy - Kidney Symptom Index - 19 (FKSI-19) score from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in Hospital Anxiety and Depression Survey (HADS) score from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:
  • Measure: Change in leisure activity score from the Godin-Leisure questionnaire from baseline to week 12 in the 4/2 and 2/1 sunitinib administration schedules
  • Time Frame: Baseline, week 12
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: September 27, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • 1. Age ≥ 18 years. 2. Histologically confirmed renal cell carcinoma (RCC) 3. One of the two following populations: 1. High risk for recurrence of RCC after nephrectomy, in the opinion of the investigator, OR 2. Locally advanced, unresectable or metastatic disease, in the opinion of the investigator, and good or intermediate risk by IDMC Heng Criteria (see Appendix I). 4. Karnofsky Performance Status (KPS) ≥ 80 (see Appendix A) 5. Good or intermediate risk by IDMC Heng Criteria (see Appendix I).4 6. Appropriate for treatment with sunitinib in the opinion of the treating physician. 7. Able to swallow sunitinib and comply with study requirements. 8. Able to walk and jog on a treadmill, in the opinion of the treating physician. 9. Must be able to complete an acceptable cardiopulmonary exercise test (CPET) at baseline (see Section 8.2), defined as at least one of the following:
  • Achieving a plateau in oxygen consumption concurrent with an increase in power output;
  • Respiratory exchange ratio ≥ 1.1 (RER);
  • Volitional exhaustion with a rating of perceived exertion ≥17 (RPE). 10. Subjects must have normal organ and marrow function as defined below:
  • Absolute neutrophil count ≥1,200/µL
  • Hemoglobin ≥9 g/dL
  • Platelets ≥75,000/µL
  • Total bilirubin ≤1.5 x institutional upper limit of normal
  • AST(SGOT)/ALT(SGPT) <2.5 x institutional upper limit of normal
  • Urine protein creatinine (UPC) ratio of <1 (see Appendix G schedule of events footnote)
  • Creatinine ≤2.0 OR creatinine clearance >30 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal (see Appendix H).
  • Left ventricular ejection fraction (LVEF) ≥lower limit of institutional normal as assessed by echocardiography. 11. For the sixteen patients who elect to participate in the optional technology portion involving electronic step counts and blood pressure monitoring, the patient must have a Bluetooth-enabled smart phone, which is compatible with the wireless health monitors. 12. For women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to the start of the study. Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. If you do become pregnant during this study or if you have unprotected sex, you must inform your study physician immediately. 13. For men who are sexually active, must agree to use a two medically acceptable forms of birth control (one of which must include a condom as a barrier method of contraception) in order to be in this study. Medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. Men must also agree to inform their partner of the potential for harm to an unborn child. She should know that if pregnancy occurs, the subject will need to report it to the study doctor, and she should promptly notify her doctor. The study doctor will ask if the subject's partner is willing to provide updates on the progress of the pregnancy and its outcome. If the subject's partner agrees, this information will be provided to Pfizer, Inc. for safety monitoring follow-up.

Exclusion Criteria:

  • 1. Any prior anti-VEGF therapies (i.e., sunitinib, sorafenib, pazopanib, axitinib, cabozantinib, bevacizumab, etc.), including in the adjuvant or neoadjuvant setting. 2. Prior systemic therapy for advanced RCC; however, treatment with immunotherapy (i.e., high-dose bolus IL-2, ipilumumab + nivolumab, etc.) is allowed. 3. Subjects who are receiving any other investigational agents. 4. Subjects who are receiving strong CYP3A4 inhibitors or CYP3A4 inducers (see Section 5.3.2.2). 5. Radiotherapy within 2 weeks prior to taking the first dose of study drug, or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. 6. Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic, and b) have no requirement for steroids or enzyme-inducing anticonvulsants in the prior 28 days. 7. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
  • Active peptic ulcer disease
  • Known intraluminal metastatic lesion(s) with risk of bleeding
  • Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions with increased risk of perforation
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment 8. History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Coronary artery bypass graft surgery
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (see Appendix J) 9. Absolute contraindications to cardiopulmonary exercise testing and/or aerobic training, as determined by the attending oncologist: Absolute Contraindications
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
  • Recurrent syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Symptomatic severe aortic stenosis
  • Uncontrolled heart failure
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • Room air desaturation at rest <85%
  • Respiratory failure
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
  • Mental impairment leading to inability to cooperate. 10. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >150 mmHg or diastolic blood pressure (DBP) of >90 mmHg]. 11. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months. 12. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement are not considered to be major surgery). 13. Osseous metastatic disease with unacceptable risk of impending fracture due to study assessments, in the opinion of the investigator 14. Evidence of active bleeding or bleeding diathesis. 15. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.

Contact:

  • Julia Rasmussen, MS, RN, BSN
  • 919-681-1030

Location:

  • Duke Cancer Institute
  • Durham North Carolina 27705 United States

View trial on ClinicalTrials.gov


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A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors


Condition: Advanced Cancer, Melanoma, Non-Small Cell Lung Cancer

Intervention:

  • Drug: BMS-986205
  • Drug: Nivolumab
  • Drug: Ipilimumab

Purpose: The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02658890

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Safety and tolerability of BMS-986205 as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities.
  • Time Frame: 100 days after the last dose of study therapy
  • Safety Issue:
  • Measure: Safety of BMS-986205 plus nivolumab as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities.
  • Time Frame: 100 days after the last dose of study therapy
  • Safety Issue:
  • Measure: Safety of BMS-986205 plus both nivolumab and ipilimumab as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities.
  • Time Frame: 100 days after the last dose of study therapy
  • Safety Issue:
  • Measure: Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the best overall response (BOR)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the duration of response (DOR)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by progression-free survival rates (PFSRs)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the best overall response (BOR)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the duration of response (DOR)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by progression-free survival rates (PFSRs)
  • Time Frame: Approximately 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Maximum observed plasma concentration (Cmax) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Time of maximum observed plasma concentration (Tmax) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Observed plasma concentration at 24 hours (C24) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Apparent terminal phase half-life (T-HALF) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Apparent total body clearance (CLT/F) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Apparent renal clearance (CLR/F) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Volume of distribution of terminal phase (Vz/F) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Apparent volume of distribution at steady state (Vss/F) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Accumulation index (AI) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Percent urinary recovery (%UR) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Percent urinary recovery over 24 hours(%UR24) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(0-T)] of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(INF)] of BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Anti-drug antibody (ADA) response to Ipilimumab in combination with BMS-986205
  • Time Frame: Approximately 3 years
  • Safety Issue:

Estimated Enrollment: 907

Study Start Date: February 18, 2016

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: All

Inclusion Criteria:

  • During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
  • During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
  • Subjects must have measurable disease
  • Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
  • At least 4 weeks since any previous treatment for cancer
  • Must be able to swallow pills or capsules
  • Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1 Exclusion Criteria:
  • Active or chronic autoimmune diseases
  • Uncontrolled or significant cardiovascular disease
  • History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
  • Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
  • Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
  • Active infection Other protocol defined inclusion/

Exclusion Criteria:

  • Active or chronic autoimmune diseases
  • Uncontrolled or significant cardiovascular disease
  • History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
  • Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
  • Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
  • Active infection Other protocol defined inclusion/exclusion criteria could apply

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:

Locations:

  • Local Institution
  • Phoenix Arizona 85054 United States
  • University of Arizona Cancer Center
  • Tucson Arizona 85724 United States
  • UCSD Moores Cancer Center
  • La Jolla California 92093-0698 United States
  • Local Institution
  • Jacksonville Florida 32224 United States
  • H. Lee Moffitt Cancer Center
  • Tampa Florida 33612-9497 United States
  • Emory Winship Cancer Institute
  • Atlanta Georgia 30322 United States
  • Northside Hospital, Inc
  • Atlanta Georgia 30342 United States
  • University Of Chicago
  • Chicago Illinois 60637 United States
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
  • Lutherville Maryland 21093 United States
  • Barbara Ann Karmanos Cancer Institute
  • Detroit Michigan 48201 United States
  • Local Institution
  • Rochester Minnesota 55905 United States
  • Washington University
  • Saint Louis Missouri 63110 United States
  • Hackensack University Medical Center
  • Hackensack New Jersey 07601 United States
  • New York University
  • New York New York 10016 United States
  • Cleveland Clinic
  • Cleveland Ohio 44195 United States
  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111-2412 United States
  • UPMC Cancer Center
  • Pittsburgh Pennsylvania 15213 United States
  • Vanderbilt University Medical Center
  • Nashville Tennessee 37232 United States
  • The Kinghorn Cancer Centre
  • Darlinghurst New South Wales 2010 Australia
  • Local Institution
  • North Sydney New South Wales 2146 Australia
  • Local Institution
  • Westmead New South Wales 2145 Australia
  • Local Institution
  • Brisbane Queensland 4102 Australia
  • Local Institution
  • Clayton Victoria 3168 Australia
  • Local Institution
  • Melbourne Victoria 3000 Australia
  • Local Institution
  • Nedlands Western Australia 6009 Australia
  • Cross Cancer Institute
  • Edmonton Alberta T6G 1Z2 Canada
  • Local Institution
  • Vancouver British Columbia V5Z 4E6 Canada
  • Local Institution
  • Toronto Ontario M5G 2M9 Canada
  • Local Institution
  • Greenfield Park Quebec J4V 2H1 Canada
  • Local Institution
  • Montreal Quebec H3T 1E2 Canada
  • Local Institution
  • Helsinki 00029 Finland
  • Local Institution
  • Helsinki 00180 Finland
  • Local Institution
  • Lille CEDEX 59037 France
  • Local Institution
  • Lyon Cedex 08 69373 France
  • Local Institution
  • Marseille Cedex 5 13385 France
  • Local Institution
  • Nantes Cedex 01 44093 France
  • Local Institution
  • Paris 75005 France
  • Local Institution
  • Toulouse 31100 France
  • Local Institution
  • Villejuif 94800 France
  • Universitatsklinikum Essen
  • Essen 45147 Germany
  • Klinikum Am Gesundbrunnen
  • Heilbronn 74078 Germany
  • Local Institution
  • Milano 20132 Italy
  • Local Institution
  • Milano 20133 Italy
  • Local Institution
  • Milano 20141 Italy
  • Local Institution
  • Rozzano MI 20089 Italy
  • Local Institution
  • Oslo 0424 Norway
  • Oddzial Badan Wczesnych Faz
  • Warszawa Mazowieckie 02-781 Poland
  • Local Institution
  • Gdansk 80-952 Poland
  • Local Institution
  • Barcelona 08035 Spain
  • Local Institution
  • Madrid 28040 Spain
  • Local Institution
  • Madrid 28050 Spain
  • Local Institution
  • Solna 171 64 Sweden

View trial on ClinicalTrials.gov


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A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti−PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy


Condition: Renal Cell Carcinoma

Intervention:

  • Drug: Atezolizumab
  • Other: Placebo

Purpose: This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03024996

Sponsor: Hoffmann-La Roche

Primary Outcome Measures:

  • Measure: IRF-assessed Disease-Free Survival (DFS)
  • Time Frame: From Baseline until first documented recurrence event (up to approximately 88 months)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall Survival
  • Time Frame: From Baseline up to death due to any cause (up to approximately 88 months)
  • Safety Issue:
  • Measure: Investigator-assessed DFS
  • Time Frame: From Baseline up to first occurence of event by investigator assessment (up to approximately 88 months)
  • Safety Issue:
  • Measure: IRF-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3
  • Time Frame: From Baseline until first occurrence of DFS event (up to approximately 88 months)
  • Safety Issue:
  • Measure: Investigator-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
  • Time Frame: From Baseline until first occurrence of DFS event (up to approximately 88 months)
  • Safety Issue:
  • Measure: Disease-Specific Survival
  • Time Frame: From Baseline up to death due to RCC (up to approximately 88 months)
  • Safety Issue:
  • Measure: Distant Metastasis-Free Survival
  • Time Frame: From Baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 88 months)
  • Safety Issue:
  • Measure: Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 3
  • Time Frame: Year 3
  • Safety Issue:
  • Measure: Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 3
  • Time Frame: Year 3
  • Safety Issue:
  • Measure: Percentage of Participants With Adverse Events
  • Time Frame: From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 1 year)
  • Safety Issue:
  • Measure: Maximum Serum Concentration (Cmax) of Atezolizumab
  • Time Frame: Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
  • Safety Issue:
  • Measure: Minimum Serum Concentration (Cmin) of Atezolizumab
  • Time Frame: Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
  • Safety Issue:
  • Measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab
  • Time Frame: Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
  • Safety Issue:

Estimated Enrollment: 664

Study Start Date: January 3, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • ECOG performance status of less than or equal to (
  • Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence
  • Radical or partial nephrectomy with lymphadenectomy in select participants
  • Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization. Confirmation of disease-free status will be assessed by an independent central radiologic review of imaging data.
  • Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants
  • Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery

Exclusion Criteria:

  • Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau
  • Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment
  • Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
  • History of autoimmune disease
  • Participants with prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
  • Positive test for HIV
  • Participants with active hepatitis B or hepatitis C
  • Active tuberculosis
  • Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
  • Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD−1), or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or pathway-targeting agents
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
  • Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study

Contact:

  • Reference Study ID Number: WO39210 www.roche.com/about_roche/roche_worldwide.htm
  • 888-662-6728 (U.S. and Canada)

Locations:

  • Banner MD Anderson Cancer Center
  • Gilbert Arizona 85234 United States
  • Mayo Clinic- Scottsdale
  • Scottsdale Arizona 85259 United States
  • City of Hope National Medical Center
  • Duarte California 91010 United States
  • Moores Cancer Center at UC San Diego Health
  • La Jolla California 92093 United States
  • City of Hope, Antelope Valley
  • Lancaster California 93534 United States
  • Cedars-Sinai Medical Center
  • Los Angeles California 90048 United States
  • UCLA Urology; Urology
  • Los Angeles California United States
  • University of California Irvine Medical Center
  • Orange California 92868 United States
  • City of Hope; Rancho Cucamonga
  • Rancho Cucamonga California 91730 United States
  • City of Hope-South Pasadena
  • South Pasadena California 91030 United States
  • University of Colorado Cancer Center
  • Aurora Colorado 80045 United States
  • The Urology Center of Colorado
  • Denver Colorado 80211 United States
  • Yale School of Medicine
  • New Haven Connecticut 06510 United States
  • Florida Cancer Specialists-Broadway, Fort Myers
  • Fort Myers Florida 33908 United States
  • University of Florida
  • Gainesville Florida 32607 United States
  • Mayo Clinic-Jacksonville
  • Jacksonville Florida 32224 United States
  • Univ of Miami, School of Med; Hem/Onc
  • Miami Florida 33136 United States
  • Moffitt Cancer Center
  • Tampa Florida 33647 United States
  • Emory Uni - Winship Cancer Center; Hematology/Oncology
  • Atlanta Georgia 30322 United States
  • Emory University Clinic
  • Atlanta Georgia 30322 United States
  • The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
  • Chicago Illinois 60637 United States
  • Loyola University Medical Center, Cardinal Bernardin Cancer Center
  • Maywood Illinois 60151 United States
  • University of Iowa Hospitals & Clinics; Internal Medicine
  • Iowa City Iowa 52242 United States
  • Norton Cancer Institute
  • Louisville Kentucky 40202 United States
  • Tulane Uni Health Sciences Center
  • New Orleans Louisiana 70112 United States
  • Ochsner Clinic Foundation
  • New Orleans Louisiana 70121 United States
  • New England Cancer Specialists
  • Scarborough Maine 04074 United States
  • Chesapeake Urology Research Associates
  • Towson Maryland 21204 United States
  • Mayo Clinic - Rochester
  • Rochester Minnesota 55905 United States
  • Sarah Cannon Research Institute - Kansas City - HCA Midwest Health
  • Kansas City Missouri 64132 United States
  • Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
  • Lincoln Nebraska 68510 United States
  • Garden State Urology
  • Whippany New Jersey United States
  • New York Oncology Hematology at Albany Medical Center
  • Albany New York 12208 United States
  • New York Oncology Hematology, P.C.
  • Albany New York 12208 United States
  • Bellevue Hospital
  • New York New York 10016 United States
  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
  • New York New York 10016 United States
  • Mount SInai Medical Center
  • New York New York 10029 United States
  • Columbia University Medical Center
  • New York New York 10032 United States
  • University of Rochester Medical Center; Urology
  • Rochester New York 14642 United States
  • Stony Brook University Medical Center
  • Stony Brook New York 11794 United States
  • SUNY Upstate Medical University
  • Syracuse New York 13210 United States
  • University of North Carolina at Chapel Hill
  • Chapel Hill North Carolina 27514 United States
  • Levine Cancer Institute
  • Charlotte North Carolina 28204 United States
  • Duke Cancer Center
  • Durham North Carolina 27710 United States
  • Fairview Hospital; Cleveland Clinic Cancer Center
  • Cleveland Ohio 44111 United States
  • Cleveland Clinic Foundation; Hematology and Oncology
  • Cleveland Ohio 44195 United States
  • Hillcrest Hospital; Hirsch Cancer Center
  • Mayfield Heights Ohio 44124 United States
  • University of Oklahoma; Stephenson Oklahoma Canc Ctr
  • Oklahoma City Oklahoma 73104 United States
  • Oregon Health & Science Uni
  • Portland Oregon 97239 United States
  • Penn State Hershey Cancer Institute
  • Hershey Pennsylvania 17033 United States
  • Lancaster Urology
  • Lancaster Pennsylvania 17604 United States
  • Thomas Jefferson University Hospital;Medical Oncology
  • Philadelphia Pennsylvania 19107 United States
  • Fox Chase Cancer Center; Hematology/Oncology
  • Philadelphia Pennsylvania 19111 United States
  • UPMC Cancer Centers
  • Pittsburgh Pennsylvania 15232 United States
  • Carolina Urologic Research Center
  • Myrtle Beach South Carolina 29572 United States
  • Sanford Cancer Cnt Onco Clinic
  • Sioux Falls South Dakota 57104 United States
  • Erlanger Health Systems
  • Chattanooga Tennessee 37403 United States
  • Urology Associates of Kingsport, P.C.
  • Kingsport Tennessee United States
  • Sarah Cannon Research Institute
  • Nashville Tennessee 37203 United States
  • Vanderbilt University Medical Center; Vanderbilt University
  • Nashville Tennessee 37232 United States
  • University of Texas Southwestern Medical Center
  • Dallas Texas 75390 United States
  • MD Anderson Cancer Center
  • Houston Texas 77030-4095 United States
  • University of Utah; Huntsman Cancer Hospital
  • Salt Lake City Utah 84112 United States
  • Seattle Cancer Care Alliance
  • Seattle Washington 98109 United States
  • West Virginia University Hospitals Inc
  • Morgantown West Virginia 26056 United States
  • Hospital Britanico; Oncologia
  • Buenos Aires C1280AEB Argentina
  • Hospital Aleman
  • Caba C1118AAT Argentina
  • Centro Oncologico Riojano Integral (CORI)
  • La Rioja F5300COE Argentina
  • Calvary Mater Newcastle; Medical Oncology
  • Waratah New South Wales 2298 Australia
  • Royal Brisbane & Women's Hosp; Cancer Care Serv
  • Herston Queensland 4029 Australia
  • Ashford Cancer Center Research
  • Kurralta Park South Australia 5037 Australia
  • Austin Hospital; Medical Oncology
  • Heidelberg Victoria 3084 Australia
  • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
  • Graz 8036 Austria
  • Ordensklinikum Linz Barmherzige Schwestern; Urologie
  • Linz 4010 Austria
  • Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
  • Salzburg 5020 Austria
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
  • Wien 1090 Austria
  • Cliniques Universitaires St-Luc
  • Bruxelles 1200 Belgium
  • Grand Hôpital de Charleroi Notre Dame
  • Charleroi 6000 Belgium
  • AZ Groeninge
  • Kortrijk 8500 Belgium
  • UZ Leuven Gasthuisberg
  • Leuven 3000 Belgium
  • CHU UCL Mont-Godinne
  • Mont-godinne 5530 Belgium
  • Cetus Hospital Dia Oncologia
  • Belo Horizonte MG 30150-270 Brazil
  • Hospital Luxemburgo; Oncologia
  • Belo Horizonte MG 31190-131 Brazil
  • Hospital Erasto Gaertner
  • Curitiba PR 81520-060 Brazil
  • Hospital das Clinicas - UFRGS
  • Porto Alegre RS 90035-003 Brazil
  • Hospital Sao Lucas - PUCRS
  • Porto Alegre RS 90610-000 Brazil
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Sao Paulo SP 01246-000 Brazil
  • Hospital Alemao Oswaldo Cruz
  • Sao Paulo SP 01323-903 Brazil
  • Tom Baker Cancer Centre-Calgary
  • Calgary Alberta T2N 4N2 Canada
  • Cross Cancer Institute
  • Edmonton Alberta T6G 1Z2 Canada
  • Bcca - Cancer Center Southern Interior
  • Kelowna British Columbia V1Y 5L3 Canada
  • BCCA-Vancouver Cancer Centre
  • Vancouver British Columbia V5Z 4E6 Canada
  • Queen Elizabeth II Health Sciences Centre; Oncology
  • Halifax Nova Scotia B3H 2Y9 Canada
  • Hamilton Health Sciences - Juravinski Cancer Centre
  • Hamilton Ontario L8V 5C2 Canada
  • The Ottawa Hospital Cancer Centre; Oncology
  • Ottawa Ontario K1H 8L6 Canada
  • North York General Hospital; Inpatient Pharmacy
  • Toronto Ontario M2K 1E1 Canada
  • Sunnybrook Odette Cancer Centre
  • Toronto Ontario M4N 3M5 Canada
  • Princess Margaret Cancer Center
  • Toronto Ontario M5G 1Z5 Canada
  • McGill University Health Center
  • Montreal Quebec H4A 3J1 Canada
  • CHUS (Centre Hospitalier Universitaire de Sherbrooke)
  • Sherbrooke Quebec J1H 5N4 Canada
  • Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
  • Quebec G1R 3S1 Canada
  • Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
  • Recoleta 8420383 Chile
  • Sociedad de Investigaciones Medicas Ltda (SIM)
  • Temuco 4810469 Chile
  • ONCOCENTRO APYS; Oncología
  • Vina Del Mar 2520598 Chile
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Nanjing City 210029 China
  • Jiangsu Cancer Hospital
  • Nanjing 210009 China
  • Fudan University Shanghai Cancer Center; Medical Oncology
  • Shanghai 200032 China
  • Masarykuv onkologicky ustav
  • Brno 656 53 Czechia
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Olomouc 779 00 Czechia
  • General University Hospital; CLINIC OF ONCOLOGY
  • Praha 2 128 08 Czechia
  • Thomayerova nemocnice
  • Praha 4 - Krc 140 59 Czechia
  • Fakultni nemocnice Kralovske Vinohrady
  • Praha 110 34 Czechia
  • Aarhus Universitetshospital; Kræftafdelingen
  • Aarhus N 8200 Denmark
  • Herlev Hospital; Onkologisk afdeling
  • Herlev 2730 Denmark
  • Odense Universitetshospital, Onkologisk Afdeling R
  • Odense C 5000 Denmark
  • CHU d'Angers
  • Angers 49033 France
  • CHU Henri Mondor; Service d'Oncologie Medicale
  • Creteil 94010 France
  • CHU Grenoble Hopital Albert Michallon; Urologie et Transplantation rénale
  • La Tronche 38700 France
  • Polyclinique de Limoges - Site Chenieux; Oncologie Medicale
  • Limoges 87039 France
  • CHU de Nantes - Hotel Dieu
  • Nantes 44093 France
  • Institut Mutualiste Montsouris; Oncologie
  • Paris 75674 France
  • CHU Pontchaillou
  • Rennes 35000 France
  • CHU de Rouen - Hôpital Charles Nicolle
  • Rouen 76031 France
  • Nouvel Hopital Civil - CHU Strasbourg; Urologie
  • Strasbourg 67091 France
  • Institut Gustave Roussy
  • Villejuif 94805 France
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
  • Dresden 01307 Germany
  • Kliniken Essen-Mitte; Klinik für Urologie, Kinderurologie und Urologische Onkologie
  • Essen 45136 Germany
  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
  • Hamburg 20246 Germany
  • Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
  • Hannover 30625 Germany
  • Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
  • Heidelberg 69120 Germany
  • Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
  • Homburg/Saar 66424 Germany
  • Uniklinik Köln, Klinik für Urologie, Uro-Onkologie und spezielle urologische Chirurgie
  • Köln 50937 Germany
  • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
  • München 81675 Germany
  • Universitätsklinikum Tübingen; Klinik für Urologie
  • Tübingen 72076 Germany
  • Universitätsklinikum Ulm; Klinik für Urologie
  • Ulm 89081 Germany
  • Cork Uni Hospital; Oncology Dept
  • Cork Ireland
  • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
  • Dublin 24 Ireland
  • Soroka Medical Center; Oncology Dept
  • Beer Sheva 8410101 Israel
  • Rambam Health Care Campus; Oncology
  • Haifa 3109601 Israel
  • Hadassah Ein Karem Hospital; Oncology Dept
  • Jerusalem 9112001 Israel
  • Meir Medical Center; Oncology
  • Kfar-Saba 4428164 Israel
  • Belinson Medical Center, Division of Oncology
  • Petach Tikva 4941492 Israel
  • Chaim Sheba medical center, Oncology division
  • Ramat Gan 5262000 Israel
  • Sourasky Medical Center
  • Tel-Aviv 6423900 Israel
  • Az. Osp. Cardarelli; Divisione Di Oncologia
  • Napoli Campania 80131 Italy
  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • Bologna Emilia-Romagna 40138 Italy
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Meldola Emilia-Romagna 47014 Italy
  • A.O. Universitaria Policlinico Di Modena; Oncologia
  • Modena Emilia-Romagna 41100 Italy
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Milano Lombardia 20133 Italy
  • Fondazione IRCCS Policlinico San Matteo, Oncologia
  • Pavia Lombardia 27100 Italy
  • Istituti Clinici Scientifici Maugeri SpA-SB
  • Pavia Lombardia 27100 Italy
  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
  • Arezzo Toscana 52100 Italy
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
  • Padova Veneto 35128 Italy
  • Nagoya University Hospital
  • Aichi 466-8560 Japan
  • Hirosaki University Hospital
  • Aomori 036-8563 Japan
  • Kyushu University Hospital
  • Fukuoka 812-8582 Japan
  • Hiroshima City Hiroshima Citizens Hospital
  • Hiroshima 730-8518 Japan
  • Kobe University Hospital
  • Hyogo 650-0017 Japan
  • University of Tsukuba Hospital
  • Ibaraki 305-8576 Japan
  • Kagoshima City Hospital
  • Kagoshima 890-8760 Japan
  • Mie University Hospital
  • Mie 514-8507 Japan
  • Niigata University Medical & Dental Hospital
  • Niigata 951-8520 Japan
  • Okayama University Hospital
  • Okayama 700-8558 Japan
  • Kindai University Hospital
  • Osaka 589-8511 Japan
  • Tokushima University Hospital
  • Tokushima 770-8503 Japan
  • Toranomon Hospital
  • Tokyo 105-8470 Japan
  • Tokyo Medical & Dental University Hospital
  • Tokyo 113-8519 Japan
  • Nippon Medical School Hospital
  • Tokyo 113-8603 Japan
  • Tokyo Women's Medical University Medical Center East
  • Tokyo 116-8567 Japan
  • The Cancer Institute Hospital of JFCR
  • Tokyo 135-8550 Japan
  • Keio University Hospital
  • Tokyo 160-8582 Japan
  • National Cancer Center
  • Gyeonggi-do 10408 Korea, Republic of
  • Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Samsung Medical Center
  • Seoul 6351 Korea, Republic of
  • VU Medisch Centrum; VU University Medical Center
  • Amsterdam 1007 MB Netherlands
  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • Amsterdam 1066 CX Netherlands
  • Academ Ziekenhuis Groningen; Medical Oncology
  • Groningen 9713 GZ Netherlands
  • UMC Radboud Nijmegen
  • Nijmegen 6500 HB Netherlands
  • Sint Franciscus Gasthuis; Inwendige Geneeskunde
  • Rotterdam 3045 PM Netherlands
  • St. Antonius locatie Leidsche Rijn
  • Utrecht 3543 AZ Netherlands
  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
  • Krakow 31-531 Poland
  • Centrum Onkologii Instytut Klinika Nowotworow Ukladowych i Uogolnionych
  • Krakow Poland
  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
  • Lublin 20-090 Poland
  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
  • Poznan 60-570 Poland
  • Centralny Szpital Kliniczny MSWiA; Klinika Onkologii i Hematologii
  • Warsaw 02-507 Poland
  • Saint Elizabeth's Hospital
  • Warsaw 02-616 Poland
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Wroclaw 50-556 Poland
  • Moscow City Clinical Hospital #57; Oncourology
  • Moskva Moskovskaja Oblast 105077 Russian Federation
  • Altai Region Oncology Dispensory; Oncology
  • Barnaul 656049 Russian Federation
  • Sverdlovsk Regional Clinical Hospital 1
  • Ekaterinburg 620102 Russian Federation
  • Ivanovo Regional Oncology Dispensary
  • Ivanovo 153040 Russian Federation
  • Blokhin Cancer Research Center; Urological Dept
  • Moscow 115478 Russian Federation
  • First Moscow State Medical University n.a. I.M. Sechenov
  • Moscow 119991 Russian Federation
  • P.A. Herzen Oncological Inst. ; Oncology
  • Moscow 125284 Russian Federation
  • City Clinical Oncology Hospital
  • Moscow 143423 Russian Federation
  • Privolzhsk Regional Medical Center
  • Nizhny Novgorod 603001 Russian Federation
  • City Clinical Oncology Dispensary
  • Saint-Petersburg 197022 Russian Federation
  • Multidisciplinary clinic Reaviz
  • Samara 443011 Russian Federation
  • Scientific Research Oncology Institute named after N.N. Petrov; Oncology
  • St. Petersburg 197758 Russian Federation
  • Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
  • Belgrade 11000 Serbia
  • Clinic for Urology; Military Medical Academy
  • Belgrade 11000 Serbia
  • Institute for Oncology and Radiology of Serbia; Medical Oncology
  • Belgrade 11000 Serbia
  • Oncology Institute of Vojvodina
  • Sremska Kamenica 21204 Serbia
  • Hospital Univ. Central de Asturias; Servicio de Oncologia
  • Oviedo Asturias 33011 Spain
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Córdoba Cordoba 14004 Spain
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Santiago de Compostela LA Coruña 15706 Spain
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Barcelona 08035 Spain
  • Hospital Clínic i Provincial; Servicio de Oncología
  • Barcelona 08036 Spain
  • Institut Catala d Oncologia Hospital Duran i Reynals
  • Barcelona 08908 Spain
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid 28007 Spain
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid 28034 Spain
  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Madrid 28040 Spain
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid 28041 Spain
  • China Medical University Hospital; Urology
  • Taichung 40447 Taiwan
  • Taichung Veterans General Hospital; Division of Urology
  • Taichung 407 Taiwan
  • National Taiwan University Hospital, Department of Urology
  • Taipei 10048 Taiwan
  • TAIPEI VETERANS GENERAL HOSPITAL, Urology
  • Taipei 11217 Taiwan
  • Chang Gung Medical Foundation-Linkou, Urinary Oncology
  • Taoyuan 333 Taiwan
  • Division of Urological surgery; Department of surgery, Chulalongkorn University
  • Bangkok 10330 Thailand
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Bangkok 10400 Thailand
  • Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
  • Chiangmai 50200 Thailand
  • Adana City Hospital, Medical Oncology
  • Adana 01060 Turkey
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Adana 01250 Turkey
  • Gazi University Medical Faculty; Department of İnternal Medicine
  • Ankara 06500 Turkey
  • Ankara Uni School of Medicine; Medical Oncology
  • Ankara 06590 Turkey
  • Trakya University Medical Faculty
  • Edirne 22030 Turkey
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Sıhhiye, Ankara 06100 Turkey
  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
  • Kharkiv Kharkiv Governorate 61037 Ukraine
  • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
  • Dnipropetrovsk 49102 Ukraine
  • GU "Institution of urology of Academy Medical science of Ukraine"
  • Kiev 04053 Ukraine
  • National Institute of Cancer
  • Kyiv 03022 Ukraine
  • Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
  • Lviv 79031 Ukraine
  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
  • Sumy 40005 Ukraine
  • Zaporizhzhia Regional Clinic
  • Zaporizhzhia 69600 Ukraine
  • Leicester Royal Infirmary
  • Leicester LE1 5WW United Kingdom
  • Royal Free Hospital
  • London NW3 2QS United Kingdom
  • Christie Hospital
  • Manchester M20 3BG United Kingdom
  • Freeman Hospital
  • Newcastle upon Tyne NE7 7DN United Kingdom
  • Weston Park Hospital
  • Sheffield S10 2SJ United Kingdom
  • Singleton Hospital; Pharmacy Department
  • Swansea SA2 8QA United Kingdom

View trial on ClinicalTrials.gov


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A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)


Condition: Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7, Type 1 Papillary Renal Cell Carcinoma, Type 2 Papillary Renal Cell Carcinoma, Unresectable Renal Cell Carcinoma

Intervention:

  • Drug: Cabozantinib S-malate
  • Drug: Crizotinib
  • Other: Laboratory Biomarker Analysis
  • Drug: Savolitinib
  • Drug: Sunitinib Malate

Purpose: This randomized phase II trial studies how well cabozantinib s-malate, crizotinib, savolitinib, or sunitinib malate work in treating patients with kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib s-malate, crizotinib, savolitinib, and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02761057

Sponsor: National Cancer Institute (NCI)

Primary Outcome Measures:

  • Measure: Progression free survival (PFS)
  • Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Response rate (RR)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Incidence of toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
  • Time Frame: Up to 3 years
  • Safety Issue:

Estimated Enrollment: 180

Study Start Date: April 5, 2016

Phase: Phase 2

Eligibility:

  • Age: minimum N/A maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection; (NOTE: a designation of type I or type II should be made by the local pathologist if possible); mixed histologies containing type I or type II will be allowed provided that they contain >= 50% of the papillary component
  • Patients must also have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; disease X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; if there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan should be performed at baseline (within 42 days prior to registration); all disease must be assessed and documented on the Baseline Tumor Assessment form
  • Patients with a history of treated brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levetiracetam, gabapentin)
  • Patients must not have cavitating pulmonary lesions; patients must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration
  • Patients may have received prior surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
  • Patients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib); if a patient develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic renal cell carcinoma (RCC); if a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC; patients may have also received prior immunotherapy; patients must not have received a MET/hepatocyte growth factor (HGF) inhibitor or sunitinib as prior therapy; at least 14 days must have elapsed since completion of prior systemic therapy; patients must have recovered from all associated toxicities at the time of registration
  • Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 14 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
  • Patients must not be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipravavir/RIT, or voriconazole); strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); potent inhibitors of CYP1A2 (e.g. ciprofloxacin); and/or drugs known to be CYP3A4 substrates with a narrow therapeutic range (e.g., diergotamine, ergotamine) within 14 days prior to randomization; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution
  • Patients must not be receiving or planning to receive any other investigational agents
  • Patients must have a complete physical examination and medical history within 28 days prior to registration
  • Patients must have a Zubrod performance status of 0
  • 1
  • White blood cell count (WBC) >= 2,000/mcL (must be obtained within 28 days prior to registration)
  • Absolute neutrophil count (ANC) >= 1,000/mcL (must be obtained within 28 days prior to registration)
  • Platelet count >= 75,000/mcL (must be obtained within 28 days prior to registration)
  • Serum bilirubin =< 1.5 x institutional upper limits of normal (ULN) (must be obtained within 28 days prior to registration)
  • Serum transaminase (serum glutamic oxaloacetic transaminase [SGOT]/aspartate aminotransferase [AST] and serum glutamate pyruvate transaminase [SGPT]/alanine aminotransferase [ALT]) must be =< 2.5 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT/SGPT) must be =< 5 x the institutional ULN (must be obtained within 28 days prior to registration)
  • Serum creatinine must be =< 2 x the institutional ULN OR creatinine clearance (either measured or calculated) must be > 30 mL/min (must be obtained within 28 days prior to registration)
  • Patients must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] class III [moderate] or class IV [severe]) at the time of registration; baseline echocardiogram within 28 days of registration must demonstrate an ejection fraction (EF) >= 50%; patients must have corrected QT (QTc) interval < 500 msec on prestudy electrocardiogram (EKG) and no known history of congenital long QT syndrome; patients must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 3 months prior to registration and not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 6 months of registration; prestudy EKG must be obtained within 28 days prior to registration
  • Baseline urinalysis should show urine protein < 3+ and must be obtained within 28 days prior to registration; if urine protein is 3+ or greater, then urine protein by 24 hour collection must show less than 3 grams of protein
  • Patients must not have inadequately controlled hypertension; patients must have documented blood pressures of systolic blood pressure (SBP) < 150 and diastolic blood pressure (DBP) < 90 within 14 days of starting randomization; blood pressure medications (any number) are permitted
  • Patients must be able to take oral medications (i.e., swallow pills whole); patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease; patients with intractable nausea or vomiting are not eligible
  • Patients must not have had any clinically-significant GI bleeding within 6 months prior to registration and patients must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula; examples of this include (but are not limited to) Crohn's disease or tumor with transmural extension through the gastrointestinal lining
  • Patients must not have had hemoptysis of >= 0.5 teaspoon (2.5 ml) of red blood within 3 months prior registration
  • Patients must not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior to registration
  • Patient's baseline imaging must not indicate the presence of tumor invading or encasing any major blood vessels
  • Patients must not have any unresolved wounds from previous surgery
  • Albumin, alkaline phosphatase, bicarbonate, blood urea (BUN), chloride, glucose, phosphorus, and total protein must be assessed within 28 days of registration
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 3 years; men receiving active surveillance for prostate cancer may also be enrolled
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
  • Patients must have tissue available and be willing to submit for independent pathologic review in order to classify type I versus type II papillary disease
  • Patients must be offered the opportunity to participate in specimen banking for future translational medicine studies
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Locations:

  • Anchorage Associates in Radiation Medicine
  • Anchorage Alaska 98508 United States
  • Anchorage Radiation Therapy Center
  • Anchorage Alaska 99504 United States
  • Alaska Breast Care and Surgery LLC
  • Anchorage Alaska 99508 United States
  • Alaska Oncology and Hematology LLC
  • Anchorage Alaska 99508 United States
  • Alaska Women's Cancer Care
  • Anchorage Alaska 99508 United States
  • Anchorage Oncology Centre
  • Anchorage Alaska 99508 United States
  • Katmai Oncology Group
  • Anchorage Alaska 99508 United States
  • Providence Alaska Medical Center
  • Anchorage Alaska 99508 United States
  • Veteran's Administration Medical Center
  • Little Rock Arkansas 72205 United States
  • PCR Oncology
  • Arroyo Grande California 93420 United States
  • Sutter Auburn Faith Hospital
  • Auburn California 95602 United States
  • Sutter Cancer Centers Radiation Oncology Services-Auburn
  • Auburn California 95603 United States
  • AIS Cancer Center at San Joaquin Community Hospital
  • Bakersfield California 93301 United States
  • Alta Bates Summit Medical Center-Herrick Campus
  • Berkeley California 94704 United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Burbank California 91505 United States
  • Mills-Peninsula Medical Center
  • Burlingame California 94010 United States
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  • Cameron Park California 95682 United States
  • Eden Hospital Medical Center
  • Castro Valley California 94546 United States
  • Sutter Davis Hospital
  • Davis California 95616 United States
  • City of Hope Comprehensive Cancer Center
  • Duarte California 91010 United States
  • Epic Care-Dublin
  • Dublin California 94568 United States
  • Bay Area Breast Surgeons Inc
  • Emeryville California 94608 United States
  • Epic Care Partners in Cancer Care
  • Emeryville California 94608 United States
  • Palo Alto Medical Foundation-Fremont
  • Fremont California 94538 United States
  • Los Angeles County-USC Medical Center
  • Los Angeles California 90033 United States
  • USC / Norris Comprehensive Cancer Center
  • Los Angeles California 90033 United States
  • Cedars Sinai Medical Center
  • Los Angeles California 90048 United States
  • Contra Costa Regional Medical Center
  • Martinez California 94553-3156 United States
  • Fremont - Rideout Cancer Center
  • Marysville California 95901 United States
  • Memorial Medical Center
  • Modesto California 95355 United States
  • Palo Alto Medical Foundation-Camino Division
  • Mountain View California 94040 United States
  • Palo Alto Medical Foundation-Gynecologic Oncology
  • Mountain View California 94040 United States
  • USC Norris Oncology/Hematology-Newport Beach
  • Newport Beach California 92663 United States
  • Sutter Cancer Research Consortium
  • Novato California 94945 United States
  • Alta Bates Summit Medical Center - Summit Campus
  • Oakland California 94609 United States
  • Bay Area Tumor Institute
  • Oakland California 94609 United States
  • Palo Alto Medical Foundation Health Care
  • Palo Alto California 94301 United States
  • Keck Medical Center of USC Pasadena
  • Pasadena California 91105 United States
  • Sutter Cancer Centers Radiation Oncology Services-Roseville
  • Roseville California 95661 United States
  • Sutter Roseville Medical Center
  • Roseville California 95661 United States
  • Sutter Medical Center Sacramento
  • Sacramento California 95816 United States
  • University of California Davis Comprehensive Cancer Center
  • Sacramento California 95817 United States
  • California Pacific Medical Center-Pacific Campus
  • San Francisco California 94115 United States
  • Palo Alto Medical Foundation-Santa Cruz
  • Santa Cruz California 95065 United States
  • Sutter Pacific Medical Foundation
  • Santa Rosa California 95403 United States
  • Palo Alto Medical Foundation-Sunnyvale
  • Sunnyvale California 94086 United States
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
  • Truckee California 96161 United States
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville
  • Vacaville California 95687 United States
  • Sutter Solano Medical Center/Cancer Center
  • Vallejo California 94589 United States
  • Epic Care Cyberknife Center
  • Walnut Creek California 94597 United States
  • Grand Valley Oncology
  • Grand Junction Colorado 81501 United States
  • Smilow Cancer Hospital Care Center at Saint Francis
  • Hartford Connecticut 06105 United States
  • Smilow Cancer Center/Yale-New Haven Hospital
  • New Haven Connecticut 06510 United States
  • Yale University
  • New Haven Connecticut 06520 United States
  • Sibley Memorial Hospital
  • Washington District of Columbia 20016 United States
  • Mount Sinai Comprehensive Cancer Center at Aventura
  • Aventura Florida 33180 United States
  • Holy Cross Hospital
  • Fort Lauderdale Florida 33308 United States
  • Mount Sinai Medical Center
  • Miami Beach Florida 33140 United States
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Savannah Georgia 31405 United States
  • Low Country Cancer Care Associates PC
  • Savannah Georgia 31405 United States
  • Summit Cancer Care-Candler
  • Savannah Georgia 31405 United States
  • Hawaii Cancer Care - Savio
  • 'Aiea Hawaii 96701 United States
  • Hawaii Oncology Inc-Pali Momi
  • 'Aiea Hawaii 96701 United States
  • Pali Momi Medical Center
  • 'Aiea Hawaii 96701 United States
  • The Cancer Center of Hawaii-Pali Momi
  • 'Aiea Hawaii 96701 United States
  • Hawaii Cancer Care Inc-POB II
  • Honolulu Hawaii 96813 United States
  • Hawaii Oncology Inc-POB I
  • Honolulu Hawaii 96813 United States
  • Island Urology
  • Honolulu Hawaii 96813 United States
  • Queen's Medical Center
  • Honolulu Hawaii 96813 United States
  • Straub Clinic and Hospital
  • Honolulu Hawaii 96813 United States
  • University of Hawaii Cancer Center
  • Honolulu Hawaii 96813 United States
  • Hawaii Cancer Care Inc-Liliha
  • Honolulu Hawaii 96817 United States
  • Hawaii Oncology Inc-Kuakini
  • Honolulu Hawaii 96817 United States
  • Kuakini Medical Center
  • Honolulu Hawaii 96817 United States
  • The Cancer Center of Hawaii-Liliha
  • Honolulu Hawaii 96817 United States
  • Kapiolani Medical Center for Women and Children
  • Honolulu Hawaii 96826 United States
  • Wilcox Memorial Hospital and Kauai Medical Clinic
  • Lihue Hawaii 96766 United States
  • Saint Alphonsus Cancer Care Center-Boise
  • Boise Idaho 83706 United States
  • Saint Luke's Mountain States Tumor Institute
  • Boise Idaho 83712 United States
  • Saint Alphonsus Cancer Care Center-Caldwell
  • Caldwell Idaho 83605 United States
  • Kootenai Medical Center
  • Coeur d'Alene Idaho 83814 United States
  • Walter Knox Memorial Hospital
  • Emmett Idaho 83617 United States
  • Saint Luke's Mountain States Tumor Institute - Fruitland
  • Fruitland Idaho 83619 United States
  • Idaho Urologic Institute-Meridian
  • Meridian Idaho 83642 United States
  • Saint Luke's Mountain States Tumor Institute - Meridian
  • Meridian Idaho 83642 United States
  • Saint Alphonsus Medical Center-Nampa
  • Nampa Idaho 83686 United States
  • Saint Luke's Mountain States Tumor Institute - Nampa
  • Nampa Idaho 83686 United States
  • Kootenai Cancer Center
  • Post Falls Idaho 83854 United States
  • Kootenai Cancer Clinic
  • Sandpoint Idaho 83864 United States
  • Saint Luke's Mountain States Tumor Institute-Twin Falls
  • Twin Falls Idaho 83301 United States
  • Rush - Copley Medical Center
  • Aurora Illinois 60504 United States
  • Saint Joseph Medical Center
  • Bloomington Illinois 61701 United States
  • Illinois CancerCare-Bloomington
  • Bloomington Illinois 61704 United States
  • Illinois CancerCare-Canton
  • Canton Illinois 61520 United States
  • Memorial Hospital of Carbondale
  • Carbondale Illinois 62902 United States
  • SIH Cancer Institute
  • Carterville Illinois 62918 United States
  • Illinois CancerCare-Carthage
  • Carthage Illinois 62321 United States
  • Centralia Oncology Clinic
  • Centralia Illinois 62801 United States
  • Northwestern University
  • Chicago Illinois 60611 United States
  • University of Chicago Comprehensive Cancer Center
  • Chicago Illinois 60637 United States
  • Carle on Vermilion
  • Danville Illinois 61832 United States
  • Cancer Care Specialists of Illinois - Decatur
  • Decatur Illinois 62526 United States
  • Decatur Memorial Hospital
  • Decatur Illinois 62526 United States
  • Carle Physician Group-Effingham
  • Effingham Illinois 62401 United States
  • Crossroads Cancer Center
  • Effingham Illinois 62401 United States
  • Illinois CancerCare-Eureka
  • Eureka Illinois 61530 United States
  • Illinois CancerCare-Galesburg
  • Galesburg Illinois 61401 United States
  • Western Illinois Cancer Treatment Center
  • Galesburg Illinois 61401 United States
  • Illinois CancerCare-Kewanee Clinic
  • Kewanee Illinois 61443 United States
  • Northwestern Medicine Lake Forest Hospital
  • Lake Forest Illinois 60045 United States
  • Illinois CancerCare-Macomb
  • Macomb Illinois 61455 United States
  • Carle Physician Group-Mattoon/Charleston
  • Mattoon Illinois 61938 United States
  • Loyola University Medical Center
  • Maywood Illinois 60153 United States
  • Good Samaritan Regional Health Center
  • Mount Vernon Illinois 62864 United States
  • UC Comprehensive Cancer Center at Silver Cross
  • New Lenox Illinois 60451 United States
  • Illinois CancerCare-Ottawa Clinic
  • Ottawa Illinois 61350 United States
  • Radiation Oncology of Northern Illinois
  • Ottawa Illinois 61350 United States
  • Illinois CancerCare-Pekin
  • Pekin Illinois 61554 United States
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  • Pekin Illinois 61554 United States
  • Illinois CancerCare-Peoria
  • Peoria Illinois 61615 United States
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  • Peoria Illinois 61615 United States
  • Methodist Medical Center of Illinois
  • Peoria Illinois 61636 United States
  • OSF Saint Francis Medical Center
  • Peoria Illinois 61637 United States
  • Illinois CancerCare-Peru
  • Peru Illinois 61354 United States
  • Valley Radiation Oncology
  • Peru Illinois 61354 United States
  • Illinois CancerCare-Princeton
  • Princeton Illinois 61356 United States
  • SwedishAmerican Regional Cancer Center/ACT
  • Rockford Illinois 61114 United States
  • Central Illinois Hematology Oncology Center
  • Springfield Illinois 62702 United States
  • Southern Illinois University School of Medicine
  • Springfield Illinois 62702 United States
  • Springfield Clinic
  • Springfield Illinois 62702 United States
  • Memorial Medical Center
  • Springfield Illinois 62781 United States
  • Cancer Care Specialists of Illinois-Swansea
  • Swansea Illinois 62226 United States
  • Southwest Illinois Health Services LLP
  • Swansea Illinois 62226 United States
  • Carle Cancer Center
  • Urbana Illinois 61801 United States
  • The Carle Foundation Hospital
  • Urbana Illinois 61801 United States
  • Rush-Copley Healthcare Center
  • Yorkville Illinois 60560 United States
  • Deaconess Clinic Downtown
  • Evansville Indiana 47713 United States
  • Indiana University/Melvin and Bren Simon Cancer Center
  • Indianapolis Indiana 46202 United States
  • Franciscan Saint Anthony Health-Michigan City
  • Michigan City Indiana 46360 United States
  • Woodland Cancer Care Center
  • Michigan City Indiana 46360 United States
  • Memorial Regional Cancer Center Day Road
  • Mishawaka Indiana 46545 United States
  • Chancellor Center for Oncology
  • Newburgh Indiana 47630 United States
  • Reid Health
  • Richmond Indiana 47374 United States
  • Memorial Hospital of South Bend
  • South Bend Indiana 46601 United States
  • Iowa Methodist Medical Center
  • Des Moines Iowa 50309 United States
  • Medical Oncology and Hematology Associates-Des Moines
  • Des Moines Iowa 50309 United States
  • Broadlawns Medical Center
  • Des Moines Iowa 50314 United States
  • Iowa Lutheran Hospital
  • Des Moines Iowa 50316 United States
  • Trinity Regional Medical Center
  • Fort Dodge Iowa 50501 United States
  • Methodist West Hospital
  • West Des Moines Iowa 50266-7700 United States
  • Cancer Center of Kansas - Chanute
  • Chanute Kansas 66720 United States
  • Cancer Center of Kansas - Dodge City
  • Dodge City Kansas 67801 United States
  • Cancer Center of Kansas - El Dorado
  • El Dorado Kansas 67042 United States
  • Cancer Center of Kansas - Fort Scott
  • Fort Scott Kansas 66701 United States
  • Central Care Cancer Center - Garden City
  • Garden City Kansas 67846 United States
  • Central Care Cancer Center - Great Bend
  • Great Bend Kansas 67530 United States
  • Cancer Center of Kansas-Independence
  • Independence Kansas 67301 United States
  • Cancer Center of Kansas-Kingman
  • Kingman Kansas 67068 United States
  • Lawrence Memorial Hospital
  • Lawrence Kansas 66044 United States
  • Kansas Institute of Medicine Cancer and Blood Center
  • Lenexa Kansas 66219 United States
  • Minimally Invasive Surgery Hospital
  • Lenexa Kansas 66219 United States
  • Cancer Center of Kansas-Liberal
  • Liberal Kansas 67905 United States
  • Cancer Center of Kansas-Manhattan
  • Manhattan Kansas 66502 United States
  • Cancer Center of Kansas - McPherson
  • McPherson Kansas 67460 United States
  • Cancer Center of Kansas - Newton
  • Newton Kansas 67114 United States
  • Menorah Medical Center
  • Overland Park Kansas 66209 United States
  • Saint Luke's South Hospital
  • Overland Park Kansas 66213 United States
  • Cancer Center of Kansas - Parsons
  • Parsons Kansas 67357 United States
  • Cancer Center of Kansas - Pratt
  • Pratt Kansas 67124 United States
  • Cancer Center of Kansas - Salina
  • Salina Kansas 67401 United States
  • Cancer Center of Kansas - Wellington
  • Wellington Kansas 67152 United States
  • Associates In Womens Health
  • Wichita Kansas 67208 United States
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Wichita Kansas 67208 United States
  • Cancer Center of Kansas - Wichita
  • Wichita Kansas 67214 United States
  • Via Christi Regional Medical Center
  • Wichita Kansas 67214 United States
  • Cancer Center of Kansas - Winfield
  • Winfield Kansas 67156 United States
  • Oncology Hematology Care Inc-Crestview
  • Crestview Hills Kentucky 41017 United States
  • East Jefferson General Hospital
  • Metairie Louisiana 70006 United States
  • Louisiana State University Health Science Center
  • New Orleans Louisiana 70112 United States
  • University Medical Center New Orleans
  • New Orleans Louisiana 70112 United States
  • Ochsner Medical Center Jefferson
  • New Orleans Louisiana 70121 United States
  • Greater Baltimore Medical Center
  • Baltimore Maryland 21204 United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Baltimore Maryland 21287 United States
  • Boston Medical Center
  • Boston Massachusetts 02118 United States
  • Mercy Medical Center
  • Springfield Massachusetts 01104 United States
  • Saint Joseph Mercy Hospital
  • Ann Arbor Michigan 48106 United States
  • University of Michigan Comprehensive Cancer Center
  • Ann Arbor Michigan 48109 United States
  • Bronson Battle Creek
  • Battle Creek Michigan 49017 United States
  • IHA Hematology Oncology Consultants-Brighton
  • Brighton Michigan 48114 United States
  • Saint Joseph Mercy Brighton
  • Brighton Michigan 48114 United States
  • IHA Hematology Oncology Consultants-Canton
  • Canton Michigan 48188 United States
  • Saint Joseph Mercy Canton
  • Canton Michigan 48188 United States
  • Caro Cancer Center
  • Caro Michigan 48723 United States
  • IHA Hematology Oncology Consultants-Chelsea
  • Chelsea Michigan 48118 United States
  • Saint Joseph Mercy Chelsea
  • Chelsea Michigan 48118 United States
  • Hematology Oncology Consultants-Clarkston
  • Clarkston Michigan 48346 United States
  • Newland Medical Associates-Clarkston
  • Clarkston Michigan 48346 United States
  • Beaumont Hospital-Dearborn
  • Dearborn Michigan 48124 United States
  • Wayne State University/Karmanos Cancer Institute
  • Detroit Michigan 48201 United States
  • Ascension Saint John Hospital
  • Detroit Michigan 48236 United States
  • Great Lakes Cancer Management Specialists-Doctors Park
  • East China Township Michigan 48054 United States
  • Weisberg Cancer Treatment Center
  • Farmington Hills Michigan 48334 United States
  • Genesee Cancer and Blood Disease Treatment Center
  • Flint Michigan 48503 United States
  • Genesee Hematology Oncology PC
  • Flint Michigan 48503 United States
  • Genesys Hurley Cancer Institute
  • Flint Michigan 48503 United States
  • Hurley Medical Center
  • Flint Michigan 48503 United States
  • Mercy Health Saint Mary's
  • Grand Rapids Michigan 49503 United States
  • Spectrum Health at Butterworth Campus
  • Grand Rapids Michigan 49503 United States
  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  • Grosse Pointe Woods Michigan 48236 United States
  • Lymphoma Clinic of Michigan
  • Grosse Pointe Woods Michigan 48236 United States
  • Michigan Breast Specialists-Grosse Pointe Woods
  • Grosse Pointe Woods Michigan 48236 United States
  • Allegiance Health
  • Jackson Michigan 49201 United States
  • Bronson Methodist Hospital
  • Kalamazoo Michigan 49007 United States
  • West Michigan Cancer Center
  • Kalamazoo Michigan 49007 United States
  • Borgess Medical Center
  • Kalamazoo Michigan 49048 United States
  • Sparrow Hospital
  • Lansing Michigan 48912 United States
  • Hope Cancer Clinic
  • Livonia Michigan 48154 United States
  • Saint Mary Mercy Hospital
  • Livonia Michigan 48154 United States
  • Great Lakes Cancer Management Specialists-Macomb Medical Campus
  • Macomb Michigan 48044 United States
  • Michigan Breast Specialists-Macomb Township
  • Macomb Michigan 48044 United States
  • Saint Mary's Oncology/Hematology Associates of Marlette
  • Marlette Michigan 48453 United States
  • Mercy Health Mercy Campus
  • Muskegon Michigan 49444 United States
  • Lakeland Hospital Niles
  • Niles Michigan 49120 United States
  • 21st Century Oncology-Pontiac
  • Pontiac Michigan 48341 United States
  • Hope Cancer Center
  • Pontiac Michigan 48341 United States
  • Newland Medical Associates-Pontiac
  • Pontiac Michigan 48341 United States
  • Saint Joseph Mercy Oakland
  • Pontiac Michigan 48341 United States
  • Huron Medical Center PC
  • Port Huron Michigan 48060 United States
  • Lake Huron Medical Center
  • Port Huron Michigan 48060 United States
  • Spectrum Health Reed City Hospital
  • Reed City Michigan 49677 United States
  • Great Lakes Cancer Management Specialists-Rochester Hills
  • Rochester Hills Michigan 48309 United States
  • Saint Mary's of Michigan
  • Saginaw Michigan 48601 United States
  • Oncology Hematology Associates of Saginaw Valley PC
  • Saginaw Michigan 48604 United States
  • Lakeland Medical Center Saint Joseph
  • Saint Joseph Michigan 49085 United States
  • Marie Yeager Cancer Center
  • Saint Joseph Michigan 49085 United States
  • Bhadresh Nayak MD PC-Sterling Heights
  • Sterling Heights Michigan 48312 United States
  • Saint Joseph Health System-Tawas City
  • Tawas City Michigan 48764 United States
  • Munson Medical Center
  • Traverse City Michigan 49684 United States
  • Advanced Breast Care Center PLLC
  • Warren Michigan 48088 United States
  • Bhadresh Nayak MD PC-Warren
  • Warren Michigan 48093 United States
  • Great Lakes Cancer Management Specialists-Macomb Professional Building
  • Warren Michigan 48093 United States
  • Macomb Hematology Oncology PC
  • Warren Michigan 48093 United States
  • Michigan Breast Specialists-Warren
  • Warren Michigan 48093 United States
  • Saint John Macomb-Oakland Hospital
  • Warren Michigan 48093 United States
  • Saint Mary's Oncology/Hematology Associates of West Branch
  • West Branch Michigan 48661 United States
  • Metro Health Hospital
  • Wyoming Michigan 49519 United States
  • Huron Gastroenterology PC
  • Ypsilanti Michigan 48106 United States
  • IHA Hematology Oncology Consultants-Ann Arbor
  • Ypsilanti Michigan 48197 United States
  • Essentia Health Saint Joseph's Medical Center
  • Brainerd Minnesota 56401 United States
  • Fairview Ridges Hospital
  • Burnsville Minnesota 55337 United States
  • Mercy Hospital
  • Coon Rapids Minnesota 55433 United States
  • Essentia Health - Deer River Clinic
  • Deer River Minnesota 56636 United States
  • Essentia Health Saint Mary's - Detroit Lakes Clinic
  • Detroit Lakes Minnesota 56501 United States
  • Essentia Health Cancer Center
  • Duluth Minnesota 55805 United States
  • Essentia Health Saint Mary's Medical Center
  • Duluth Minnesota 55805 United States
  • Miller-Dwan Hospital
  • Duluth Minnesota 55805 United States
  • Fairview-Southdale Hospital
  • Edina Minnesota 55435 United States
  • Lake Region Healthcare Corporation-Cancer Care
  • Fergus Falls Minnesota 56537 United States
  • Essentia Health - Fosston
  • Fosston Minnesota 56542 United States
  • Unity Hospital
  • Fridley Minnesota 55432 United States
  • Essentia Health Hibbing Clinic
  • Hibbing Minnesota 55746 United States
  • Fairview Maple Grove Medical Center
  • Maple Grove Minnesota 55369 United States
  • Minnesota Oncology Hematology PA-Maplewood
  • Maplewood Minnesota 55109 United States
  • Saint John's Hospital - Healtheast
  • Maplewood Minnesota 55109 United States
  • Abbott-Northwestern Hospital
  • Minneapolis Minnesota 55407 United States
  • Hennepin County Medical Center
  • Minneapolis Minnesota 55415 United States
  • Health Partners Inc
  • Minneapolis Minnesota 55454 United States
  • Monticello Cancer Center
  • Monticello Minnesota 55362 United States
  • New Ulm Medical Center
  • New Ulm Minnesota 56073 United States
  • Essentia Health - Park Rapids
  • Park Rapids Minnesota 56470 United States
  • North Memorial Medical Health Center
  • Robbinsdale Minnesota 55422 United States
  • Park Nicollet Clinic - Saint Louis Park
  • Saint Louis Park Minnesota 55416 United States
  • Regions Hospital
  • Saint Paul Minnesota 55101 United States
  • United Hospital
  • Saint Paul Minnesota 55102 United States
  • Essentia Health Sandstone
  • Sandstone Minnesota 55072 United States
  • Saint Francis Regional Medical Center
  • Shakopee Minnesota 55379 United States
  • Lakeview Hospital
  • Stillwater Minnesota 55082 United States
  • Essentia Health Virginia Clinic
  • Virginia Minnesota 55792 United States
  • Ridgeview Medical Center
  • Waconia Minnesota 55387 United States
  • Rice Memorial Hospital
  • Willmar Minnesota 56201 United States
  • Minnesota Oncology Hematology PA-Woodbury
  • Woodbury Minnesota 55125 United States
  • Fairview Lakes Medical Center
  • Wyoming Minnesota 55092 United States
  • University of Mississippi Medical Center
  • Jackson Mississippi 39216 United States
  • Saint Louis Cancer and Breast Institute-Ballwin
  • Ballwin Missouri 63011 United States
  • Central Care Cancer Center - Bolivar
  • Bolivar Missouri 65613 United States
  • Parkland Health Center-Bonne Terre
  • Bonne Terre Missouri 63628 United States
  • Cox Cancer Center Branson
  • Branson Missouri 65616 United States
  • Saint Francis Medical Center
  • Cape Girardeau Missouri 63703 United States
  • Southeast Cancer Center
  • Cape Girardeau Missouri 63703 United States
  • Siteman Cancer Center at West County Hospital
  • Creve Coeur Missouri 63141 United States
  • Centerpoint Medical Center LLC
  • Independence Missouri 64057 United States
  • Capital Region Southwest Campus
  • Jefferson City Missouri 65109 United States
  • Freeman Health System
  • Joplin Missouri 64804 United States
  • Mercy Hospital Joplin
  • Joplin Missouri 64804 United States
  • Saint Luke's Hospital of Kansas City
  • Kansas City Missouri 64111 United States
  • Research Medical Center
  • Kansas City Missouri 64132 United States
  • Saint Luke's East - Lee's Summit
  • Lee's Summit Missouri 64086 United States
  • Delbert Day Cancer Institute at PCRMC
  • Rolla Missouri 65401 United States
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Rolla Missouri 65401 United States
  • Heartland Regional Medical Center
  • Saint Joseph Missouri 64507 United States
  • Saint Louis Cancer and Breast Institute-South City
  • Saint Louis Missouri 63109 United States
  • Washington University School of Medicine
  • Saint Louis Missouri 63110 United States
  • Mercy Hospital South
  • Saint Louis Missouri 63128 United States
  • Siteman Cancer Center-South County
  • Saint Louis Missouri 63129 United States
  • Missouri Baptist Medical Center
  • Saint Louis Missouri 63131 United States
  • Siteman Cancer Center at Christian Hospital
  • Saint Louis Missouri 63136 United States
  • Mercy Hospital Saint Louis
  • Saint Louis Missouri 63141 United States
  • Siteman Cancer Center at Saint Peters Hospital
  • Saint Peters Missouri 63376 United States
  • Sainte Genevieve County Memorial Hospital
  • Sainte Genevieve Missouri 63670 United States
  • Mercy Hospital Springfield
  • Springfield Missouri 65804 United States
  • CoxHealth South Hospital
  • Springfield Missouri 65807 United States
  • Missouri Baptist Sullivan Hospital
  • Sullivan Missouri 63080 United States
  • Missouri Baptist Outpatient Center-Sunset Hills
  • Sunset Hills Missouri 63127 United States
  • Mercy Hospital Washington
  • Washington Missouri 63090 United States
  • Community Hospital of Anaconda
  • Anaconda Montana 59711 United States
  • Billings Clinic Cancer Center
  • Billings Montana 59101 United States
  • Saint Vincent Healthcare
  • Billings Montana 59101 United States
  • Bozeman Deaconess Hospital
  • Bozeman Montana 59715 United States
  • Saint James Community Hospital and Cancer Treatment Center
  • Butte Montana 59701 United States
  • Benefis Healthcare- Sletten Cancer Institute
  • Great Falls Montana 59405 United States
  • Great Falls Clinic
  • Great Falls Montana 59405 United States
  • Saint Peter's Community Hospital
  • Helena Montana 59601 United States
  • Kalispell Regional Medical Center
  • Kalispell Montana 59901 United States
  • Saint Patrick Hospital - Community Hospital
  • Missoula Montana 59802 United States
  • Community Medical Hospital
  • Missoula Montana 59804 United States
  • Nebraska Hematology and Oncology
  • Lincoln Nebraska 68506 United States
  • Nebraska Cancer Research Center
  • Lincoln Nebraska 68510 United States
  • Southeast Nebraska Cancer Center
  • Lincoln Nebraska 68510 United States
  • Faith Regional Health Services Carson Cancer Center
  • Norfolk Nebraska 68701 United States
  • Great Plains Health Callahan Cancer Center
  • North Platte Nebraska 69101 United States
  • Nebraska Methodist Hospital
  • Omaha Nebraska 68114 United States
  • Nebraska Cancer Specialists - Omaha
  • Omaha Nebraska 68124 United States
  • Oncology Hematology West PC
  • Omaha Nebraska 68130 United States
  • Regional West Medical Center Cancer Center
  • Scottsbluff Nebraska 69361 United States
  • Carson Tahoe Regional Medical Center
  • Carson City Nevada 89703 United States
  • Cancer and Blood Specialists-Henderson
  • Henderson Nevada 89052 United States
  • Comprehensive Cancer Centers of Nevada - Henderson
  • Henderson Nevada 89052 United States
  • Comprehensive Cancer Centers of Nevada-Horizon Ridge
  • Henderson Nevada 89052 United States
  • Las Vegas Cancer Center-Henderson
  • Henderson Nevada 89052 United States
  • Nevada Cancer Specialists-Saint Rose
  • Henderson Nevada 89052 United States
  • 21st Century Oncology-Henderson
  • Henderson Nevada 89074 United States
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson
  • Henderson Nevada 89074 United States
  • Desert West Surgery
  • Las Vegas Nevada 89102 United States
  • Nevada Cancer Specialists?Oakey
  • Las Vegas Nevada 89102 United States
  • University Medical Center of Southern Nevada
  • Las Vegas Nevada 89102 United States
  • Cancer and Blood Specialists-Shadow
  • Las Vegas Nevada 89106 United States
  • Radiation Oncology Centers of Nevada Central
  • Las Vegas Nevada 89106 United States
  • 21st Century Oncology
  • Las Vegas Nevada 89109 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  • Las Vegas Nevada 89109 United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin
  • Las Vegas Nevada 89113 United States
  • Radiation Oncology Centers of Nevada Southeast
  • Las Vegas Nevada 89119 United States
  • Cancer Therapy and Integrative Medicine
  • Las Vegas Nevada 89121 United States
  • 21st Century Oncology-Vegas Tenaya
  • Las Vegas Nevada 89128 United States
  • Ann M Wierman MD LTD
  • Las Vegas Nevada 89128 United States
  • Cancer and Blood Specialists-Tenaya
  • Las Vegas Nevada 89128 United States
  • Comprehensive Cancer Centers of Nevada - Northwest
  • Las Vegas Nevada 89128 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  • Las Vegas Nevada 89128 United States
  • Nevada Cancer Specialists-Tenaya
  • Las Vegas Nevada 89128 United States
  • Comprehensive Cancer Centers of Nevada-Summerlin
  • Las Vegas Nevada 89144 United States
  • Summerlin Hospital Medical Center
  • Las Vegas Nevada 89144 United States
  • Las Vegas Cancer Center-Medical Center
  • Las Vegas Nevada 89148-2405 United States
  • 21st Century Oncology-Fort Apache
  • Las Vegas Nevada 89148 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89148 United States
  • Nevada Cancer Specialists-Fort Apache
  • Las Vegas Nevada 89148 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  • Las Vegas Nevada 89149 United States
  • Comprehensive Cancer Centers of Nevada - Central Valley
  • Las Vegas Nevada 89169 United States
  • University Cancer Center
  • Las Vegas Nevada 89169 United States
  • Hope Cancer Care of Nevada-Pahrump
  • Pahrump Nevada 89048 United States
  • Renown Regional Medical Center
  • Reno Nevada 89502 United States
  • Saint Mary's Regional Medical Center
  • Reno Nevada 89503 United States
  • Radiation Oncology Associates
  • Reno Nevada 89509 United States
  • University of New Mexico Cancer Center
  • Albuquerque New Mexico 87102 United States
  • New Mexico Cancer Care Alliance
  • Albuquerque New Mexico 87106 United States
  • Montefiore Medical Center-Einstein Campus
  • Bronx New York 10461 United States
  • Montefiore Medical Center-Weiler Hospital
  • Bronx New York 10461 United States
  • Montefiore Medical Center - Moses Campus
  • Bronx New York 10467 United States
  • State University of New York Upstate Medical University
  • Syracuse New York 13210 United States
  • SUNY Upstate Medical Center-Community Campus
  • Syracuse New York 13215 United States
  • Asheville Hematology-Oncology Associates
  • Asheville North Carolina 28803 United States
  • Southeastern Medical Oncology Center-Clinton
  • Clinton North Carolina 28328 United States
  • Haywood Infusion Center
  • Clyde North Carolina 28721 United States
  • Duke University Medical Center
  • Durham North Carolina 27710 United States
  • Southeastern Medical Oncology Center-Goldsboro
  • Goldsboro North Carolina 27534 United States
  • Wayne Memorial Hospital
  • Goldsboro North Carolina 27534 United States
  • Hendersonville Hematology and Oncology at Pardee
  • Hendersonville North Carolina 28791 United States
  • Margaret R Pardee Memorial Hospital
  • Hendersonville North Carolina 28791 United States
  • Park Ridge Health
  • Hendersonville North Carolina 28792 United States
  • Onslow Memorial Hospital
  • Jacksonville North Carolina 28546 United States
  • Southeastern Medical Oncology Center-Jacksonville
  • Jacksonville North Carolina 28546 United States
  • Southeastern Medical Oncology Center-Wilson
  • Wilson North Carolina 27893 United States
  • Essentia Health Cancer Center-South University Clinic
  • Fargo North Dakota 58103 United States
  • Essentia Health - Jamestown Clinic
  • Jamestown North Dakota 58401 United States
  • Indu and Raj Soin Medical Center
  • Beavercreek Ohio 45431 United States
  • Strecker Cancer Center-Belpre
  • Belpre Ohio 45714 United States
  • Dayton Physicians LLC-Miami Valley South
  • Centerville Ohio 45459 United States
  • Miami Valley Hospital South
  • Centerville Ohio 45459 United States
  • Adena Regional Medical Center
  • Chillicothe Ohio 45601 United States
  • Oncology Hematology Care Inc-Eden Park
  • Cincinnati Ohio 45202 United States
  • Oncology Hematology Care Inc-Mercy West
  • Cincinnati Ohio 45211 United States
  • Oncology Hematology Care Inc - Anderson
  • Cincinnati Ohio 45230 United States
  • Oncology Hematology Care Inc-Kenwood
  • Cincinnati Ohio 45236 United States
  • Oncology Hematology Care Inc-Blue Ash
  • Cincinnati Ohio 45242 United States
  • Mount Carmel East Hospital
  • Columbus Ohio 43213 United States
  • Columbus Oncology and Hematology Associates Inc
  • Columbus Ohio 43214 United States
  • Riverside Methodist Hospital
  • Columbus Ohio 43214 United States
  • Grant Medical Center
  • Columbus Ohio 43215 United States
  • The Mark H Zangmeister Center
  • Columbus Ohio 43219 United States
  • Mount Carmel Health Center West
  • Columbus Ohio 43222 United States
  • Doctors Hospital
  • Columbus Ohio 43228 United States
  • Good Samaritan Hospital - Dayton
  • Dayton Ohio 45406 United States
  • Miami Valley Hospital
  • Dayton Ohio 45409 United States
  • Dayton Physicians LLC-Samaritan North
  • Dayton Ohio 45415 United States
  • Miami Valley Hospital North
  • Dayton Ohio 45415 United States
  • Delaware Health Center-Grady Cancer Center
  • Delaware Ohio 43015 United States
  • Delaware Radiation Oncology
  • Delaware Ohio 43015 United States
  • Grady Memorial Hospital
  • Delaware Ohio 43015 United States
  • Oncology Hematology Care Inc-Healthplex
  • Fairfield Ohio 45014 United States
  • Armes Family Cancer Center
  • Findlay Ohio 45840 United States
  • Blanchard Valley Hospital
  • Findlay Ohio 45840 United States
  • Orion Cancer Care
  • Findlay Ohio 45840 United States
  • Atrium Medical Center-Middletown Regional Hospital
  • Franklin Ohio 45005-1066 United States
  • Dayton Physicians LLC-Atrium
  • Franklin Ohio 45005 United States
  • Dayton Physicians LLC-Wayne
  • Greenville Ohio 45331 United States
  • Wayne Hospital
  • Greenville Ohio 45331 United States
  • Greater Dayton Cancer Center
  • Kettering Ohio 45409 United States
  • First Dayton Cancer Care
  • Kettering Ohio 45420 United States
  • Kettering Medical Center
  • Kettering Ohio 45429 United States
  • Fairfield Medical Center
  • Lancaster Ohio 43130 United States
  • OhioHealth Mansfield Hospital
  • Mansfield Ohio 44903 United States
  • Marietta Memorial Hospital
  • Marietta Ohio 45750 United States
  • OhioHealth Marion General Hospital
  • Marion Ohio 43302 United States
  • Dayton Physicians LLC-Signal Point
  • Middletown Ohio 45042 United States
  • Knox Community Hospital
  • Mount Vernon Ohio 43050 United States
  • Licking Memorial Hospital
  • Newark Ohio 43055 United States
  • Newark Radiation Oncology
  • Newark Ohio 43055 United States
  • Southern Ohio Medical Center
  • Portsmouth Ohio 45662 United States
  • Dayton Physicians LLC-Wilson
  • Sidney Ohio 45365 United States
  • Springfield Regional Cancer Center
  • Springfield Ohio 45504 United States
  • Springfield Regional Medical Center
  • Springfield Ohio 45505 United States
  • Trinity's Tony Teramana Cancer Center
  • Steubenville Ohio 43952 United States
  • Dayton Physicians LLC-Upper Valley
  • Troy Ohio 45373 United States
  • Upper Valley Medical Center
  • Troy Ohio 45373 United States
  • Saint Ann's Hospital
  • Westerville Ohio 43081 United States
  • Genesis Healthcare System Cancer Care Center
  • Zanesville Ohio 43701 United States
  • Cancer Centers of Southwest Oklahoma Research
  • Lawton Oklahoma 73505 United States
  • University of Oklahoma Health Sciences Center
  • Oklahoma City Oklahoma 73104 United States
  • Mercy Hospital Oklahoma City
  • Oklahoma City Oklahoma 73120 United States
  • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • Tulsa Oklahoma 74146 United States
  • Saint Alphonsus Medical Center-Baker City
  • Baker City Oregon 97814 United States
  • Saint Charles Health System
  • Bend Oregon 97701 United States
  • Clackamas Radiation Oncology Center
  • Clackamas Oregon 97015 United States
  • Providence Oncology and Hematology Care Southeast
  • Clackamas Oregon 97015 United States
  • Bay Area Hospital
  • Coos Bay Oregon 97420 United States
  • Providence Newberg Medical Center
  • Newberg Oregon 97132 United States
  • Saint Alphonsus Medical Center-Ontario
  • Ontario Oregon 97914 United States
  • Providence Willamette Falls Medical Center
  • Oregon City Oregon 97045 United States
  • Providence Portland Medical Center
  • Portland Oregon 97213 United States
  • Providence Saint Vincent Medical Center
  • Portland Oregon 97225 United States
  • Oregon Health and Science University
  • Portland Oregon 97239 United States
  • Saint Charles Health System-Redmond
  • Redmond Oregon 97756 United States
  • Lehigh Valley Hospital-Cedar Crest
  • Allentown Pennsylvania 18103 United States
  • UPMC-Heritage Valley Health System Beaver
  • Beaver Pennsylvania 15009 United States
  • Lehigh Valley Hospital - Muhlenberg
  • Bethlehem Pennsylvania 18017 United States
  • UPMC Cancer Centers - Arnold Palmer Pavilion
  • Greensburg Pennsylvania 15601 United States
  • UPMC-Johnstown/John P. Murtha Regional Cancer Center
  • Johnstown Pennsylvania 15901 United States
  • UPMC Cancer Center at UPMC McKeesport
  • McKeesport Pennsylvania 15132 United States
  • UPMC-Coraopolis/Heritage Valley Radiation Oncology
  • Moon Pennsylvania 15108 United States
  • Penn Presbyterian Medical Center
  • Philadelphia Pennsylvania 19104 United States
  • University of Pennsylvania/Abramson Cancer Center
  • Philadelphia Pennsylvania 19104 United States
  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111 United States
  • UPMC-Magee Womens Hospital
  • Pittsburgh Pennsylvania 15213 United States
  • UPMC-Presbyterian Hospital
  • Pittsburgh Pennsylvania 15213 United States
  • UPMC-Saint Margaret
  • Pittsburgh Pennsylvania 15215 United States
  • University of Pittsburgh Cancer Institute (UPCI)
  • Pittsburgh Pennsylvania 15232 United States
  • UPMC-Shadyside Hospital
  • Pittsburgh Pennsylvania 15232 United States
  • UPMC Jefferson Regional Radiation Oncology
  • Pittsburgh Pennsylvania 15236 United States
  • UPMC-Passavant Hospital
  • Pittsburgh Pennsylvania 15237 United States
  • UPMC-Saint Clair Hospital Cancer Center
  • Pittsburgh Pennsylvania 15243 United States
  • UPMC Cancer Center at UPMC Northwest
  • Seneca Pennsylvania 16346 United States
  • UPMC Uniontown Hospital Radiation Oncology
  • Uniontown Pennsylvania 15401 United States
  • UPMC Washington Hospital Radiation Oncology
  • Washington Pennsylvania 15301 United States
  • Medical University of South Carolina
  • Charleston South Carolina 29425 United States
  • Greenville Health System Cancer Institute-Easley
  • Easley South Carolina 29640 United States
  • Saint Francis Hospital
  • Greenville South Carolina 29601 United States
  • Greenville Health System Cancer Institute-Butternut
  • Greenville South Carolina 29605 United States
  • Greenville Health System Cancer Institute-Faris
  • Greenville South Carolina 29605 United States
  • Greenville Memorial Hospital
  • Greenville South Carolina 29605 United States
  • Saint Francis Cancer Center
  • Greenville South Carolina 29607 United States
  • Greenville Health System Cancer Institute-Eastside
  • Greenville South Carolina 29615 United States
  • Greenville Health System Cancer Institute-Greer
  • Greer South Carolina 29650 United States
  • Greenville Health System Cancer Institute-Seneca
  • Seneca South Carolina 29672 United States
  • Greenville Health System Cancer Institute-Spartanburg
  • Spartanburg South Carolina 29307 United States
  • University of Texas Medical Branch
  • Galveston Texas 77555-0565 United States
  • UTMB Cancer Center at Victory Lakes
  • League City Texas 77573 United States
  • University Hospital
  • San Antonio Texas 78229 United States
  • University of Texas Health Science Center at San Antonio
  • San Antonio Texas 78229 United States
  • Farmington Health Center
  • Farmington Utah 84025 United States
  • Huntsman Cancer Institute/University of Utah
  • Salt Lake City Utah 84112 United States
  • South Jordan Health Center
  • South Jordan Utah 84009 United States
  • University of Virginia Cancer Center
  • Charlottesville Virginia 22908 United States
  • Providence Regional Cancer System-Aberdeen
  • Aberdeen Washington 98520 United States
  • Cancer Care Center at Island Hospital
  • Anacortes Washington 98221 United States
  • PeaceHealth Saint Joseph Medical Center
  • Bellingham Washington 98225 United States
  • Providence Regional Cancer System-Centralia
  • Centralia Washington 98531 United States
  • Swedish Medical Center-Edmonds
  • Edmonds Washington 98026 United States
  • Providence Regional Cancer Partnership
  • Everett Washington 98201 United States
  • Swedish Cancer Institute-Issaquah
  • Issaquah Washington 98029 United States
  • Providence Regional Cancer System-Lacey
  • Lacey Washington 98503 United States
  • PeaceHealth Saint John Medical Center
  • Longview Washington 98632 United States
  • Pacific Gynecology Specialists
  • Seattle Washington 98104 United States
  • Swedish Medical Center-Ballard Campus
  • Seattle Washington 98107 United States
  • Kaiser Permanente Washington
  • Seattle Washington 98112 United States
  • Swedish Medical Center-First Hill
  • Seattle Washington 98122-4307 United States
  • PeaceHealth United General Medical Center
  • Sedro-Woolley Washington 98284 United States
  • Providence Regional Cancer System-Shelton
  • Shelton Washington 98584 United States
  • Rockwood Clinic Cancer Treatment Center-Valley
  • Spokane Valley Washington 99216 United States
  • Rockwood Cancer Treatment Center-DHEC-Downtown
  • Spokane Washington 99204 United States
  • Rockwood North Cancer Treatment Center
  • Spokane Washington 99218 United States
  • PeaceHealth Southwest Medical Center
  • Vancouver Washington 98664 United States
  • Providence Saint Mary Regional Cancer Center
  • Walla Walla Washington 99362 United States
  • Providence Regional Cancer System-Yelm
  • Yelm Washington 98597 United States
  • Ashland Memorial Medical Center
  • Ashland Wisconsin 54806 United States
  • Duluth Clinic Ashland
  • Ashland Wisconsin 54806 United States
  • Aurora Cancer Care-Southern Lakes VLCC
  • Burlington Wisconsin 53105 United States
  • Marshfield Clinic-Chippewa Center
  • Chippewa Falls Wisconsin 54729 United States
  • Marshfield Clinic Cancer Center - Eau Claire
  • Eau Claire Wisconsin 54701 United States
  • Marshfield Clinic Cancer Center at Sacred Heart
  • Eau Claire Wisconsin 54701 United States
  • Aurora Health Center-Fond du Lac
  • Fond Du Lac Wisconsin 54937 United States
  • Aurora Health Care Germantown Health Center
  • Germantown Wisconsin 53022 United States
  • Aurora Cancer Care-Grafton
  • Grafton Wisconsin 53024 United States
  • Aurora BayCare Medical Center
  • Green Bay Wisconsin 54311 United States
  • Aurora Cancer Care-Kenosha South
  • Kenosha Wisconsin 53142 United States
  • Marshfield Clinic - Ladysmith Center
  • Ladysmith Wisconsin 54848 United States
  • Aurora Bay Area Medical Group-Marinette
  • Marinette Wisconsin 54143 United States
  • Vince Lombardi Cancer Clinic-Marinette
  • Marinette Wisconsin 54143 United States
  • Marshfield Clinic
  • Marshfield Wisconsin 54449 United States
  • Aurora Cancer Care-Milwaukee
  • Milwaukee Wisconsin 53209 United States
  • Aurora Saint Luke's Medical Center
  • Milwaukee Wisconsin 53215 United States
  • Aurora Sinai Medical Center
  • Milwaukee Wisconsin 53233 United States
  • Marshfield Clinic-Minocqua Center
  • Minocqua Wisconsin 54548 United States
  • Cancer Center of Western Wisconsin
  • New Richmond Wisconsin 54017 United States
  • Vince Lombardi Cancer Clinic - Oshkosh
  • Oshkosh Wisconsin 54904 United States
  • Aurora Cancer Care-Racine
  • Racine Wisconsin 53406 United States
  • Lakeview Medical Center-Marshfield Clinic
  • Rice Lake Wisconsin 54868 United States
  • Marshfield Clinic-Rice Lake Center
  • Rice Lake Wisconsin 54868 United States
  • Vince Lombardi Cancer Clinic-Sheboygan
  • Sheboygan Wisconsin 53081 United States
  • Ascension Saint Michael's Hospital
  • Stevens Point Wisconsin 54481 United States
  • Marshfield Clinic Stevens Point Center
  • Stevens Point Wisconsin 54482 United States
  • Aurora Medical Center in Summit
  • Summit Wisconsin 53066 United States
  • Vince Lombardi Cancer Clinic-Two Rivers
  • Two Rivers Wisconsin 54241 United States
  • Aurora Cancer Care-Waukesha
  • Waukesha Wisconsin 53188 United States
  • Marshfield Clinic-Wausau Center
  • Wausau Wisconsin 54401 United States
  • Aurora Cancer Care-Milwaukee West
  • Wauwatosa Wisconsin 53226 United States
  • Aurora West Allis Medical Center
  • West Allis Wisconsin 53227 United States
  • Marshfield Clinic - Weston Center
  • Weston Wisconsin 54476 United States
  • Marshfield Clinic - Wisconsin Rapids Center
  • Wisconsin Rapids Wisconsin 54494 United States
  • Big Horn Basin Cancer Center
  • Cody Wyoming 82414 United States
  • Billings Clinic-Cody
  • Cody Wyoming 82414 United States
  • Welch Cancer Center
  • Sheridan Wyoming 82801 United States
  • Tom Baker Cancer Centre
  • Calgary Alberta T2N 4N2 Canada
  • Cross Cancer Institute
  • Edmonton Alberta T6G 1Z2 Canada
  • QEII Health Sciences Centre/Nova Scotia Health Authority
  • Halifax Nova Scotia B3H 2Y9 Canada
  • Saint Joseph's Healthcare Charlton Campus
  • Hamilton Ontario L8N 4A6 Canada
  • London Regional Cancer Program
  • London Ontario N6A 4L6 Canada
  • Ottawa Hospital and Cancer Center-General Campus
  • Ottawa Ontario K1H 8L6 Canada
  • Odette Cancer Centre- Sunnybrook Health Sciences Centre
  • Toronto Ontario M4N 3M5 Canada
  • CHUM - Centre Hospitalier de l'Universite de Montreal
  • Montreal Quebec H2X 3E4 Canada

View trial on ClinicalTrials.gov


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caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)


Condition: Metastatic Collecting Duct Renal Cell Carcinoma

Intervention:

  • Drug: Cabometyx

Purpose: This is a single-arm, phase II trial (monocentric) study designed to determine To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria in Metastatic Collecting Duct Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03354884

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Primary Outcome Measures:

  • Measure: Objective response rate (ORR)
  • Time Frame: 30 Month
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression free Survival (PFS)
  • Time Frame: 30 Month
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: 30 Month
  • Safety Issue:
  • Measure: Safety and Tolerability (Adverse Events)
  • Time Frame: 30 Month
  • Safety Issue:

Estimated Enrollment: 23

Study Start Date: January 12, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 85 Years
  • Gender: All

Inclusion Criteria:

  • 1. Written Informed Consent Form 2. Unresectable, advanced or metastatic collecting ducts carcinoma untreated with any systemic agent for advanced disease 3. Measurable disease as defined by RECIST v1.1 criteria 4. Age ≥18 years 5. ECOG Performance Status 0-1 6. Any of the following laboratory test findings:
  • Hemoglobin > 9 g/dL (5.6 mmol/L)
  • WBC > 2,000/mm3
  • Neutrophils > 1,500/mm3
  • Platelets > 100,000/mm3
  • AST or ALT < 3 x ULN (< 5 x ULN if liver metastases are present)
  • Total Bilirubin < 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
  • Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 40 mL/min (measured or calculated by Cockroft-Gault formula)
  • Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis
  • PT-INR/PTT ≤ 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care 7. Availability of a representative FFPE tumor specimen collected within 24 months of starting first-line cabozantinib that enables the definitive diagnosis of CDC (the archival specimen must contain adequate viable tumor tissue to enable candidate biomarkers status; the specimen may consist of a tissue block or at least 15 unstained serial sections; for core needle biopsy specimens, at least two cores should be available for evaluation) 8. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and for 4 months after the last dose of study treatment 9. Female subjects of childbearing potential must not be pregnant at screening

Exclusion Criteria:

  1. Previous therapy for advanced disease; any medical adjuvant treatment must have been stopped at least six months before entry into the study
  2. History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  3. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
  4. History of cerebrovascular accidents, including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
  5. Major surgery or trauma within 28 days before to study entry; the such as catheter placement not considered to be major surgery).
  6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before randomization.
  7. Evidence of active bleeding or bleeding diathesis and/or clinically-significant GI bleeding within 6 months before the first dose of study treatment; 3 months for pulmonary hemorrhage and patients with tumor invading or encasing any major blood vessels.
  8. Patients with GI disorders associated with a high risk of perforation or fistula formation.
  9. Subjects with clinically relevant ongoing complications from prior radiation therapy.
  10. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
  11. Previous or ongoing treatment (except for adjuvant therapies) with any of the following anti-cancer therapies: chemotherapy, immunotherapy, target therapies, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Cabozantinib
  12. Inability to swallow tablets or capsules.

Contact:

  • Giuseppe Procopio, MD
  • +390223904450

Location:

  • Giuseppe Procopio
  • Milan 20133 Italy

View trial on ClinicalTrials.gov


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A Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy


Condition: Advanced Renal Cell Carcinoma

Intervention:

  • Drug: Cabozantinib

Purpose: The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese patients with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03339219

Sponsor: Takeda

Primary Outcome Measures:

  • Measure: Objective Response Rate (ORR)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Clinical Benefit Rate (CBR)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Progression-Free Survival (PFS)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with Grade 3 or Higher TEAEs
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with Serious TEAEs
  • Time Frame: Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with TEAEs Leading to Permanent Treatment Discontinuation
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with TEAEs Leading to Dose Modification (Dose Reduction or Interruption)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with Clinically Significant Abnormal Laboratory Values
  • Time Frame: Up to approximately 2 years after enrollment of the last participant
  • Safety Issue:
  • Measure: Percentage of Participants with Clinically Significant Abnormal Vital Sign Measurements
  • Time Frame: Up to approximately 2 years after enrollment of the last participant
  • Safety Issue:

Estimated Enrollment: 35

Study Start Date: November 13, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 20 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Male or female Japanese patients 20 years of age or older on the day of consent.
  • Documented histological or cytological diagnosis of RCC with a clear-cell component.
  • Measurable disease per RECIST 1.1 as determined by the investigator.
  • Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
  • For the most recently received VEGFR-targeting TKI the following criteria must apply:
  • Must have radiographically progressed during treatment, or been treated for at least 4 weeks and radiographically progressed within 6 months after the last dose. Radiographic progression is defined as unequivocal progression of existing tumor lesions or developing new tumor lesions as assessed by the investigator on computerized tomography (CT) or magnetic resonance imaging (MRI) scans.
  • The last dose must have been within 6 months before the first day of study drug administration (Week 1 Day 1).
  • Recovery to baseline or ≤Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  • Karnofsky Performance Status (KPS) score of ≥70%.
  • Adequate organ and marrow function at Screening.

Exclusion Criteria:

  • Prior treatment with everolimus, or any other specific or selective target of rapamycin complex 1 /phosphoinositide 3-kinase/AKT inhibitor (eg, temsirolimus), or cabozantinib.
  • Receipt of any type of small-molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before Week 1 Day 1.
  • Receipt of any type of anticancer antibody (including investigational antibody) within 28 days before Week 1 Day 1.
  • Radiation therapy for bone metastasis within 14 days, and/or any other external radiation therapy within 28 days before Week 1 Day 1. Systemic treatment with radionuclides within 42 days before Week 1 Day 1. Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.

Contact:

  • Takeda Study Registration Call Center
  • +1-877-825-3327

Locations:

  • Nagoya University Hospital
  • Nagoya Aichi Japan
  • Hokkaido University Hospital
  • Sapporo Hokkaido Japan
  • Sapporo Medical University Hospital
  • Sapporo Hokkaido Japan
  • Kobe University Hospital
  • Kobe Hyogo Japan
  • Yokohama City University Hospital
  • Yokohama Kanagawa Japan
  • Yokohama City University Medical Center
  • Yokohama Kanagawa Japan
  • Kindai University Hospital
  • Osakasayama Osaka Japan
  • Osaka University Hospital
  • Suita Osaka Japan
  • Nippon Medcal School Hospital
  • Bunkyo-ku Tokyo Japan
  • Toranomon Hospital
  • Minato-ku Tokyo Japan
  • Keio University Hospital
  • Shinjuku-ku Tokyo Japan
  • Tokyo Women's Medical University Hospital
  • Shinjuku-ku Tokyo Japan
  • Kyushu University Hospital
  • Fukuoka Japan
  • Niigata University Medical and Dental Hospital
  • Niigata Japan
  • Okayama University Hospital
  • Okayama Japan
  • Osaka City University Hospital
  • Osaka Japan
  • Osaka International Cancer Institute
  • Osaka Japan
  • Tokushima University Hospital
  • Tokushima Japan
  • Yamagata University Hospital
  • Yamagata Japan

View trial on ClinicalTrials.gov


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A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Intervention:

  • Biological: Nivolumab
  • Drug: Cabozantinib
  • Drug: Sunitinib
  • Biological: Ipilimumab

Purpose: The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03141177

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Progression Free Survival (PFS) per blinded independent central review (BICR)
  • Time Frame: Up to 21 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall Survival (OS)
  • Time Frame: Up to 64 months
  • Safety Issue:
  • Measure: Objective Response Rate (ORR)
  • Time Frame: Approximately 16 months
  • Safety Issue:
  • Measure: Incidence of adverse events (AEs)
  • Time Frame: Up to 64 months
  • Safety Issue:
  • Measure: Incidence of Serious Adverse Events (SAEs)
  • Time Frame: Up to 64 months
  • Safety Issue:

Estimated Enrollment: 630

Study Start Date: July 11, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
  • No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy Exclusion Criteria:
  • Any active CNS metastases
  • Any active, known or suspected autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Other protocol defined inclusion/

Exclusion Criteria:

  • Any active CNS metastases
  • Any active, known or suspected autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Other protocol defined inclusion/exclusion criteria could apply

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • please email:

Locations:

  • Southern Cancer Center, Inc.
  • Daphne Alabama 36526 United States
  • Cancer Treatment Centers of America-Western
  • Goodyear Arizona 85338 United States
  • University of Arizona Cancer Center
  • Tucson Arizona 85724-5024 United States
  • CBCC Global Research, Inc.
  • Bakersfield California 93309 United States
  • Local Institution
  • Los Angeles California 90017 United States
  • UCLA Hematology Oncology
  • Los Angeles California 90095 United States
  • Cancer Care Associates Medical Group, Inc.
  • Redondo Beach California 90277 United States
  • Coastal Integrative Cancer Care
  • San Luis Obispo California 93401 United States
  • Central Coast Med Oncology
  • Santa Maria California 93454 United States
  • University Of Colorado Cancer Center
  • Aurora Colorado 80045 United States
  • University Cancer Blood Ctr
  • Athens Georgia 30607 United States
  • Southeastern Regional Medical Center - CTCA
  • Newnan Georgia 30265 United States
  • Rush University Med Ctr
  • Chicago Illinois 60612 United States
  • Midwestern Regional Medical Center
  • Zion Illinois 60099 United States
  • Ft. Wayne Med Onco-Hema Inc
  • Fort Wayne Indiana 46845 United States
  • Cancer Center Of Kansas
  • Wichita Kansas 67214 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Local Institution
  • Boston Massachusetts 02215 United States
  • University Of Michigan
  • Ann Arbor Michigan 48109 United States
  • HCA Midwest Division
  • Kansas City Missouri 64132 United States
  • Washington University School Of Medicine
  • Saint Louis Missouri 63110 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89169 United States
  • Local Institution
  • Buffalo New York 14263 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Local Institution
  • Cincinnati Ohio 45230 United States
  • Oregon Health & Science University
  • Portland Oregon 97239 United States
  • Lehigh Valley Health Network
  • Allentown Pennsylvania 18103 United States
  • Tennessee Oncology, PLLC
  • Nashville Tennessee 37203 United States
  • Texas Oncology
  • Austin Texas 78731 United States
  • Baylor Sammons Cancer Center
  • Dallas Texas 75246 United States
  • MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • Local Institution
  • Midland Texas 79701 United States
  • Local Institution
  • Plano Texas 75093 United States
  • Texas Cancer Center - Sherman
  • Sherman Texas 75090 United States
  • Local Institution
  • Salt Lake City Utah 84112 United States
  • Virginia Oncology Associates
  • Norfolk Virginia 23502 United States
  • Local Institution
  • Seattle Washington 98195 United States
  • Hospital Italiano De Buenos Aires
  • Ciudad Autonoma De Buenos Aire Buenos Aires 1181 Argentina
  • Local Institution
  • Córdoba Cordoba 5016 Argentina
  • Clinica Viedma S.A.
  • Viedma RIO Negro 8500 Argentina
  • Centro Medico San Roque
  • San Miguel De Tucuman Tucuman Argentina
  • Centro De Diagnostico Urologico S.R.L.
  • Buenos Aires 1120 Argentina
  • Local Institution
  • Caba 1426 Argentina
  • Instituto Oncologico De Cordoba
  • Cordoba 5000 Argentina
  • Clinica Privada Universitaria Reina Fabiola
  • Cordoba X5004FHP Argentina
  • The Kinghorn Cancer Centre
  • Darlinghurst New South Wales 2010 Australia
  • Macquarie University
  • North Ryde New South Wales Australia
  • Local Institution
  • Sydney New South Wales 2139 Australia
  • Local Institution
  • Westmead New South Wales 2145 Australia
  • Royal Brisbane and Women's Hospital
  • Herston Queensland 4006 Australia
  • Local Institution
  • South Brisbane Queensland 4101 Australia
  • Tasman Oncology Research Pty Ltd
  • Southport Queensland 4215 Australia
  • Cabrini Hospital
  • Malvern Victoria 3144 Australia
  • Affinity Clinical Research Services Pty Ltd
  • Doubleview Western Australia 6018 Australia
  • Local Institution
  • Elizabeth Vale 5112 Australia
  • Local Institution
  • Belo Horizonte Minas Gerais 30130-090 Brazil
  • Local Institution
  • Ijui RIO Grande DO SUL 98700-000 Brazil
  • Local Institution
  • Porto Alegre RIO Grande DO SUL 90610-000 Brazil
  • Local Institution
  • Porto Alegre RIO Grande DO SUL 91350-200 Brazil
  • Local Institution
  • Barretos SAO Paulo 14784-400 Brazil
  • Local Institution
  • Rio De Janeiro 20231-050 Brazil
  • Local Institution
  • Sao Paulo 01323-020 Brazil
  • Local Institution
  • Sao Paulo 05652-900 Brazil
  • Centro Internacional de Estudios Clinicos
  • Recoleta Santiago DE Chile Chile
  • Klinika onkologie a radioterapie
  • Hradec Kralove 500 05 Czechia
  • Onkologicka klinika
  • Olomouc 779 00 Czechia
  • Local Institution
  • Bordeaux 33075 France
  • Local Institution
  • Caen 14000 France
  • Local Institution
  • Lyon Cedex 08 69373 France
  • Local Institution
  • Marseille Cedex 9 13009 France
  • Local Institution
  • Montpellier Cedex 34295 France
  • Local Institution
  • Nantes 44202 France
  • Local Institution
  • Paris 75015 France
  • Local Institution
  • Strasbourg Cedex 67091 France
  • Local Institution
  • Toulouse 31100 France
  • Local Institution
  • Villejuif 94805 France
  • Universitaetsklinikum Aachen
  • Aachen 52074 Germany
  • Universitaetsklinikum Bonn
  • Bonn 53127 Germany
  • Klinik Essen-Mitte
  • Essen 45136 Germany
  • Universitaetsklinikum Jena
  • Jena 07747 Germany
  • Klinikum Rechts Der Isar Der Tum
  • Muenchen 81675 Germany
  • Klinikum Nuernberg Nord, Urologische Klinik
  • Nuernberg 90419 Germany
  • Uniklinik Tuebingen
  • Tuebingen 72076 Germany
  • Alexandra General Hospital
  • Athens 11528 Greece
  • Local Institution
  • Thessaloniki 54645 Greece
  • Local Institution
  • Haifa 3109601 Israel
  • Local Institution
  • Kfar Saba 44281 Israel
  • Local Institution
  • Petah Tikva 49414 Israel
  • Local Institution
  • Ramat Gan 52621 Israel
  • Ospedale S. Donato - Usl 8
  • Arezzo 52100 Italy
  • Ospedale San Raffaele
  • Milano 20132 Italy
  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
  • Napoli 80131 Italy
  • I.O.V. Istituto Oncologico Veneto Ircss
  • Padova Padova Italy
  • IRCCS Istituti Clinici Scientifici Maugeri
  • Pavia 27100 Italy
  • Local Institution
  • Pavia 27100 Italy
  • Local Institution
  • Akita-shi Akita 0108543 Japan
  • Local Institution
  • Hirosaki-shi Aomori 036-8563 Japan
  • Local Institution
  • Chiba-shi Chiba 260-8717 Japan
  • Local Institution
  • Sapporo-shi Hokkaido 0608648 Japan
  • Local Institution
  • Sapporo Hokkaido 0608543 Japan
  • Local Institution
  • Kobe Hyogo 6500017 Japan
  • Local Institution
  • Morioka-shi Iwate 0208505 Japan
  • Local Institution
  • Yokohama-shi Kanagawa 2360004 Japan
  • Local Institution
  • Yokohama Kanagawa 2418515 Japan
  • Local Institution
  • Nagasaki-shi Nagasaki 8528501 Japan
  • Local Institution
  • Niigata-shi Niigata 9518520 Japan
  • Local Institution
  • Okayama-shi Okayama 7008558 Japan
  • Local Institution
  • Osaka-shi Osaka 5418567 Japan
  • Local Institution
  • Osaka-shi Osaka 5458586 Japan
  • Local Institution
  • Osakasayama-shi Osaka 5898511 Japan
  • Local Institution
  • Suita-shi Osaka 5650871 Japan
  • Local Institution
  • Hidaka-shi Saitama 3501298 Japan
  • Local Institution
  • Tokushima-shi Tokushima 7708503 Japan
  • Local Institution
  • Arakawa-ku Tokyo 1668567 Japan
  • Local Institution
  • Bunkyo-ku Tokyo 1138519 Japan
  • Local Institution
  • Bunkyo-ku Tokyo 1138603 Japan
  • Local Institution
  • Minato-ku Tokyo 1058470 Japan
  • Local Institution
  • Shinjuku-Ku Tokyo 1608582 Japan
  • Local Institution
  • Yamagata-shi Yamagata 9909585 Japan
  • Local Institution
  • Fukuoka 812-8582 Japan
  • Comite Mexicano para la Prevenion de la Osteoporosis A.C.
  • Ciudad de Mexico Distrito Federal 06100 Mexico
  • Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.
  • Mexico Distrito Federal 14080 Mexico
  • Local Institution
  • Tlalpan Distrito Federal 14080 Mexico
  • Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.
  • Zapopan Jalisco 45030 Mexico
  • Local Institution
  • Monterrey Nuevo LEON 64000 Mexico
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Monterrey Nuevo LEON 64460 Mexico
  • Merida Investigacion Clincia
  • Merida Yucatan 97125 Mexico
  • Local Institution
  • Monterrey, NL 64060 Mexico
  • Hospital Medica Tec 100
  • Queretaro 76000 Mexico
  • WSS w Bialej Podlaskiej
  • Biala Podlaska 21-500 Poland
  • Ambulatorium Chemioterapii
  • Bydgoszcz 85-796 Poland
  • Wojewodzkie Centrum Onkologii
  • Gdansk 80-219 Poland
  • Instit. Prof.Dr.Ion Chiricuta
  • Cluj-Napoca 400015 Romania
  • Sf. Nectarie Oncology Center
  • Craiova 200347 Romania
  • Local Institution
  • Moscow 115478 Russian Federation
  • Local Institution
  • Moscow 117997 Russian Federation
  • Local Institution
  • Moscow 125284 Russian Federation
  • Local Institution
  • Nizhniy Novgorod 603109 Russian Federation
  • Local Institution
  • Saint-Petersburg 197758 Russian Federation
  • Local Institution
  • A Coru?a 15006 Spain
  • Local Institution
  • Barcelona 08035 Spain
  • Local Institution
  • Madrid 28009 Spain
  • Local Institution
  • Madrid 28041 Spain
  • H. U. Marques de Valdecilla
  • Santander 39008 Spain
  • Hospital Universitario Virgen Del Rocio
  • Sevilla 41013 Spain
  • Local Institution
  • Valencia 46014 Spain
  • Local Institution
  • Ankara 06018 Turkey
  • Local Institution
  • Ankara 06590 Turkey
  • Local Institution
  • Ankara 06800 Turkey
  • Local Institution
  • Antalya 07070 Turkey
  • Local Institution
  • Denizli 20070 Turkey
  • Local Institution
  • Edirne 22100 Turkey
  • Local Institution
  • Istanbul 34300 Turkey
  • Local Institution
  • London EC1A 7BE United Kingdom
  • Local Institution
  • Manchester M20 4BX United Kingdom
  • Local Institution
  • Newcastle Upon Tyne NE7 7DN United Kingdom
  • Local Institution
  • Truro TR1 3LJ United Kingdom

View trial on ClinicalTrials.gov


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