Bladder Cancer

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A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy


Condition: Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms, Urothelial Cancer, Ureteral Neoplasms, Urethral Neoplasms

Intervention:

  • Drug: Enfortumab vedotin

Purpose: This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03219333

Sponsor: Astellas Pharma Global Development, Inc.

Primary Outcome Measures:

  • Measure: Objective response rate (ORR) by an independent review facility (IRF)
  • Time Frame: Up to 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Duration of response (DOR) by an IRF
  • Time Frame: Up to 6.5 years
  • Safety Issue:
  • Measure: Disease control rate at 16 weeks (DCR16) by an IRF
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: Progression free survival (PFS) by an IRF
  • Time Frame: Up to 6.5 years
  • Safety Issue:
  • Measure: ORR by investigator assessment
  • Time Frame: Up to 6.5 years
  • Safety Issue:
  • Measure: DOR by investigator assessment
  • Time Frame: Up to 6.5 years
  • Safety Issue:
  • Measure: DCR16 by investigator assessment
  • Time Frame: 16 weeks
  • Safety Issue:
  • Measure: Progression free survival (PFS) by investigator assessment
  • Time Frame: Up to 6.5 years
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: Up to 6.5 years
  • Safety Issue:
  • Measure: Type, incidence, severity, seriousness, and relatedness of adverse events (AEs)
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years
  • Safety Issue:
  • Measure: Laboratory abnormalities
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years
  • Safety Issue:
  • Measure: Pharmacokinetics (PK) parameter for enfortumab vedotin: Maximum concentration (Cmax)
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years
  • Safety Issue:
  • Measure: PK parameter for enfortumab vedotin: Trough concentration (Ctrough)
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years
  • Safety Issue:
  • Measure: PK parameter for monomethyl auristatin E (MMAE): Cmax
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years
  • Safety Issue:
  • Measure: PK parameter for MMAE: Ctrough
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years
  • Safety Issue:
  • Measure: Incidence of antitherapeutic antibodies (ATA) to enfortumab vedotin
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 6.5 years
  • Safety Issue:

Estimated Enrollment: 120

Study Start Date: September 20, 2017

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically documented transitional cell carcinoma of the urothelium (squamous differentiation or mixed cell types allowed).
  • Metastatic disease or locally advanced disease that is not resectable.
  • Must have received prior treatment with a CPI in the locally advanced or metastatic urothelial cancer setting. A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
  • Must either have prior treatment with platinum-containing chemotherapy or be ineligible for treatment with cisplatin at time of enrollment.
  • Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
  • Tumor tissue samples must be available for submission to the sponsor prior to study treatment.
  • Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Exclusion Criteria:

  • Ongoing sensory or motor neuropathy Grade ≥2.
  • Active central nervous system (CNS) metastases.
  • Immunotherapy related colitis, uveitis, or pneumonitis.
  • Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).

Contact:

  • Seattle Genetics Trial Information Support
  • 866-333-7436

Locations:

  • Mayo Clinic Arizona
  • Scottsdale Arizona 85259 United States
  • Arizona Oncology Associates, PC - HOPE
  • Tucson Arizona 85710 United States
  • University of California Davis
  • Davis California 95616 United States
  • Keck Medical Center / University of Southern California
  • Los Angeles California 90033 United States
  • Kaiser Permanente Oakland
  • Oakland California 94611 United States
  • Chao Family Comprehensive Cancer Center University of California Irvine
  • Orange California 92868 United States
  • University of California Irvine - Newport
  • Orange California 92868 United States
  • Kaiser Permanente Roseville
  • Roseville California 95661 United States
  • Kaiser Permanente Sacramento
  • Sacramento California 95825 United States
  • Kaiser Permanente San Francisco
  • San Francisco California 94115 United States
  • Kaiser Permanente San Jose
  • San Jose California 95119 United States
  • Kaiser Permanente San Leandro
  • San Leandro California 94577 United States
  • Kaiser Permanente Santa Clara
  • Santa Clara California 95051 United States
  • Kaiser Permanente South San Francisco
  • South San Francisco California 94080 United States
  • Kaiser Permanente Medical Center Northern California
  • Vallejo California 94589 United States
  • Kaiser Permanente Walnut Creek
  • Walnut Creek California 94596 United States
  • Rocky Mountain Cancer Centers - Aurora
  • Aurora Colorado 80012 United States
  • Yale Cancer Center
  • New Haven Connecticut 06520 United States
  • Ocala Oncology Center
  • Ocala Florida 34471 United States
  • H. Lee Moffitt Cancer Center & Research Institute
  • Tampa Florida 33612 United States
  • University of Chicago
  • Chicago Illinois 60637-1470 United States
  • Johns Hopkins Medical Center
  • Baltimore Maryland 21231 United States
  • Maryland Oncology Hematology, P.A.
  • Silver Spring Maryland 20904 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Washington University School of Medicine
  • Saint Louis Missouri 63110 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89169 United States
  • New York Oncology Hematology, P.C.
  • Albany New York 12206 United States
  • New York University (NYU) Cancer Institute
  • New York New York 10016 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10021 United States
  • Mount Sinai Medical Center
  • New York New York 10029 United States
  • James P. Wilmot Cancer Center / University of Rochester Medical Center
  • Rochester New York 14642 United States
  • Cleveland Clinic, The
  • Cleveland Ohio 44195 United States
  • James Cancer Hospital / Ohio State University
  • Columbus Ohio 43210 United States
  • Northwest Cancer Specialists, P.C.
  • Tualatin Oregon 97062 United States
  • Thomas Jefferson University
  • Philadelphia Pennsylvania 19107 United States
  • Texas Oncology - Baylor Sammons Cancer Center
  • Dallas Texas 75246 United States
  • Houston Methodist Cancer Center
  • Houston Texas 77030 United States
  • University of Virginia
  • Charlottesville Virginia 22908 United States
  • Virginia Cancer Specialists, PC
  • Fairfax Virginia 22031 United States
  • Virginia Oncology Associates
  • Norfolk Virginia 23502 United States
  • Seattle Cancer Care Alliance / University of Washington
  • Seattle Washington 98109-1023 United States
  • Site 81012
  • Fukuoka Japan
  • Site 81009
  • Yamaguchi Japan

View trial on ClinicalTrials.gov


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A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors


Condition: Urothelial Carcinoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Castration-resistant Prostate Cancer

Intervention:

  • Drug: cabozantinib
  • Drug: atezolizumab
  • Drug: cabozantinib

Purpose: This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), and non-small-cell lung cancer (NSCLC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established. In the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03170960

Sponsor: Exelixis

Primary Outcome Measures:

  • Measure: Dose Escalation: MTD/Recommended Dose
  • Time Frame: Up to 6 months
  • Safety Issue:
  • Measure: Dose Expansion: ORR
  • Time Frame: Up to 31 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Incidence and severity of nonserious AEs and SAEs (Safety)
  • Time Frame: Up to 41 months
  • Safety Issue:

Estimated Enrollment: 360

Study Start Date: September 5, 2017

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:
  • Dose-Escalation Stage:
  • Subjects with UC (including renal pelvis, ureter, bladder, urethra) after prior platinum-based therapy, or
  • Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy
  • Expansion Stage:
  • Expansion Cohort 1: Subjects with RCC with clear cell histology who have not received prior systemic anticancer therapy
  • Expansion Cohort 2: Subjects with UC with transitional cell histology (including renal pelvis, ureter, bladder, urethra) who have progressed on or after platinum-containing chemotherapy
  • Expansion Cohort 3: Subjects with UC with transitional cell histology (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced, or metastatic disease
  • Expansion Cohort 4: Subjects with UC with transitional cell histology (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced, or metastatic disease
  • Expansion Cohort 5: Subjects with UC with transitional cell histology (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior immune check-point inhibitor (anti-PD1 or anti-PD-L1) as the most recent therapy for the treatment of inoperable, locally advanced, or metastatic disease.
  • Expansion Cohort 6: Subjects with metastatic CRPC (adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features) who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease.
  • Expansion Cohort 7: Subjects with Stage IV non-squamous NSCLC who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) as the most recent therapy for metastatic disease.
  • Expansion Cohort 8: Subjects with Stage IV non-squamous NSCLC who have not received prior immune checkpoint inhibitor therapy (anti-PD-1 or anti-PD-L1). 2. Measurable disease per RECIST 1.1 as determined by the investigator. 3. Tumor tissue material available (archival or recent tumor biopsy) 4. Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. 5. Age eighteen years or older on the day of consent. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7. Adequate organ and marrow function. 8. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception. 9. Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria:

  1. Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts 5 and 7 in which prior anti-PD-1 or anti-PD-L1 therapy is required for eligibility. Other restrictions regarding prior therapy may apply.
  2. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.
  3. Concomitant anticoagulation with oral anticoagulants.
  4. Subject is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.
  5. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
  6. The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).
  7. Pregnant or lactating females.
  8. Previously identified allergy or hypersensitivity to components of the study treatment formulations.
  9. Diagnosis of another malignancy within 2 years before first dose of study treatment.

Contact:

  • Exelixis Clinical Trials
  • 1-888-EXELIXIS (888-393-5494)

Locations:

  • Exelixis Clinical Site #1
  • Duarte California 91010 United States
  • Exelixis Clinical Site #3
  • Detroit Michigan 48201 United States
  • Exelixis Clinical Site #2
  • Salt Lake City Utah 84112 United States

View trial on ClinicalTrials.gov


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A Phase 1b Dose-escalation and Dose-expansion Study of Enfortumab Vedotin (ASG-22CE) in Combination With Immune Checkpoint Inhibitor (CPI) Therapy for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer


Condition: Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms, Urothelial Cancer, Ureteral Neoplasms, Urethral Neoplasms

Intervention:

  • Drug: enfortumab vedotin
  • Drug: pembrolizumab
  • Drug: atezolizumab

Purpose: This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. Patients will get the drugs twice every 21-day cycle. Patients will get enfortumab vedotin plus the CPI on day 1. Patients will get enfortumab vedotin only on day 8. This study will look at the side effects of giving the two drugs with each other. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with treatment.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03288545

Sponsor: Astellas Pharma Global Development, Inc.

Primary Outcome Measures:

  • Measure: Incidence of dose-limiting toxicity (DLT)
  • Time Frame: 21 days
  • Safety Issue:
  • Measure: Type, incidence, severity, seriousness, and relatedness of adverse events
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 22 months
  • Safety Issue:
  • Measure: Type, incidence, and severity of laboratory abnormalities
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 22 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective response rate (ORR) by investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • Time Frame: Up to 34 months
  • Safety Issue:
  • Measure: Disease control rate (DCR) by investigator assessment according to RECIST 1.1
  • Time Frame: Up to 34 months
  • Safety Issue:
  • Measure: Duration of response (DOR) by investigator assessment according to RECIST 1.1
  • Time Frame: Up to 34 months
  • Safety Issue:
  • Measure: Progression free survival (PFS) by investigator assessment according to RECIST 1.1
  • Time Frame: Up to 34 months
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: Up to 34 months
  • Safety Issue:
  • Measure: Pharmacokinetics (PK) parameter for enfortumab vedotin: Maximum concentration (Cmax)
  • Time Frame: Through 2 cycles of treatment, up to 42 days
  • Safety Issue:
  • Measure: PK parameter for monomethyl auristatin E (MMAE): Cmax
  • Time Frame: Through 2 cycles of treatment, up to 42 days
  • Safety Issue:
  • Measure: PK parameter for enfortumab vedotin: Time to maximum concentration (Tmax)
  • Time Frame: Through 2 cycles of treatment, up to 42 days
  • Safety Issue:
  • Measure: PK parameter for MMAE: Tmax
  • Time Frame: Through 2 cycles of treatment, up to 42 days
  • Safety Issue:
  • Measure: PK parameter for enfortumab vedotin: Area under the concentration-time curve (AUC)
  • Time Frame: Through 2 cycles of treatment, up to 42 days
  • Safety Issue:
  • Measure: PK parameter for MMAE: AUC
  • Time Frame: Through 2 cycles of treatment, up to 42 days
  • Safety Issue:
  • Measure: PK parameter for enfortumab vedotin: Half-life (t1/2)
  • Time Frame: Through 2 cycles of treatment, up to 42 days
  • Safety Issue:
  • Measure: PK parameter for MMAE: t1/2
  • Time Frame: Through 2 cycles of treatment, up to 42 days
  • Safety Issue:
  • Measure: Incidence of antitherapeutic antibodies (ATA) to enfortumab vedotin
  • Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to 22 months
  • Safety Issue:

Estimated Enrollment: 85

Study Start Date: October 11, 2017

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically documented transitional cell carcinoma of the urothelium (squamous differentiation or mixed cell types allowed).
  • Locally advanced disease that is not resectable or metastatic disease.
  • Eligible to receive treatment with a CPI.
  • Either ineligible for first-line cisplatin-based chemotherapy or have disease progression during or following treatment with at least one platinum-containing regimen.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.

Exclusion Criteria:

  • Received any prior treatment with a CPI.
  • Received any prior treatment with CD137 agonists or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors.
  • Ongoing sensory or motor neuropathy Grade 2 or higher.
  • Active central nervous system (CNS) metastases.
  • Ongoing clinically significant toxicity (Grade 2 or greater) associated with prior treatment (including radiotherapy or surgery).
  • Patients with conditions requiring high doses of steroids or other immunosuppressive medications are excluded.
  • Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).

Contact:

  • Seattle Genetics Trial Information Support
  • 866-333-7436

Locations:

  • Stanford Cancer Center / Blood & Marrow Transplant Program
  • Stanford California 94305 United States
  • University of Colorado Hospital / University of Colorado
  • Aurora Colorado 80045-0510 United States
  • Yale Cancer Center
  • New Haven Connecticut 06520 United States
  • University of Miami
  • Miami Florida 33136 United States
  • Winship Cancer Institute / Emory University School of Medicine
  • Atlanta Georgia 30322 United States
  • University of Kansas Cancer Center
  • Westwood Kansas 66205 United States
  • Hackensack University Medical Center
  • Hackensack New Jersey 07601 United States
  • Weill Cornell Medical College
  • New York New York 10065 United States
  • Levine Cancer Institute
  • Charlotte North Carolina 28204 United States
  • Case Western Reserve University / University Hospitals Case Medical Center
  • Cleveland Ohio 44106 United States
  • Medical University of South Carolina/Hollings Cancer Center
  • Charleston South Carolina 29425 United States

View trial on ClinicalTrials.gov


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A Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients Who Have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)


Condition: UC (Urothelial Cancer)

Intervention:

  • Drug: Pembrolizumab
  • Drug: Epacadostat
  • Drug: Placebo

Purpose: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03374488

Sponsor: Incyte Corporation

Primary Outcome Measures:

  • Measure: Overall survival (OS) with pembrolizumab + epacadostat versus pembrolizumab + placebo
  • Time Frame: Up to 27 months
  • Safety Issue:
  • Measure: Progression-free survival (PFS) with pembrolizumab + epacadostat versus pembrolizumab + placebo
  • Time Frame: Up to 27 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective response rate with pembrolizumab + epacadostat versus pembrolizumab + placebo
  • Time Frame: Approximately 24 months
  • Safety Issue:
  • Measure: Number of participants experiencing adverse events (AEs) compared between pembrolizumab + epacadostat versus pembrolizumab + placebo [Safety and Tolerability]
  • Time Frame: Up to 27 months
  • Safety Issue:
  • Measure: Number of participants discontinuing study treatment due to AEs compared between pembrolizumab + epacadostat versus pembrolizumab + placebo [Safety and Tolerability]
  • Time Frame: Up to 27 months
  • Safety Issue:
  • Measure: Mean change from baseline in global health status/quality of life scales
  • Time Frame: Up to 25 months
  • Safety Issue:
  • Measure: Time to true deterioration (TTD)
  • Time Frame: Up to 25 months
  • Safety Issue:

Estimated Enrollment: 648

Study Start Date: December 22, 2017

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type.
  • Progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. A participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ≤ 12 months following completion of therapy.
  • Measurable disease based on RECIST v1.1.
  • Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for PD-L1 analysis.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

  • Urothelial carcinoma that is suitable for local therapy with curative intent.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
  • Known history of or is positive for active hepatitis B (HBsAg reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  • Use of protocol-defined prior/concomitant therapy.

Contact:

  • Incyte Corporation Call Center (US)
  • 1.855.463.3463

Locations:

  • Ironwood Cancer & Research Centers
  • Chandler Arizona 85224 United States
  • University of California Irvine Medical Center
  • Orange California 92868 United States
  • University of California San Francisco
  • San Francisco California 94107 United States
  • UCLA Hematology Oncology Santa Monica
  • Santa Monica California 90404 United States
  • Smilow Cancer Center at Yale-New Haven
  • New Haven Connecticut 06510 United States
  • Northside Hospital, Inc. - GCS/Annex
  • Atlanta Georgia 30341 United States
  • University of Chicago
  • Chicago Illinois 60637 United States
  • Quincy Medical Group
  • Quincy Illinois 62301 United States
  • Johns Hopkins University
  • Baltimore Maryland 21287 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • University of Michigan Health System
  • Ann Arbor Michigan 48109 United States
  • NYU Clinical Cancer Center
  • New York New York 10016 United States
  • Oklahoma Cancer Specialists & Research Institute
  • Tulsa Oklahoma 74146 United States
  • Oregon Health & Science University
  • Portland Oregon 97210 United States
  • University of Pennsylvania
  • Philadelphia Pennsylvania 19104 United States
  • Thomas Jefferson University Hospital
  • Philadelphia Pennsylvania 19107 United States
  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111 United States
  • Medical University of South Carolina-Hollings Cancer Center
  • Charleston South Carolina 29425 United States
  • University of Tennessee Medical Center Knoxville
  • Knoxville Tennessee 37920 United States
  • Vanderbilt-Ingram Cancer Center
  • Nashville Tennessee 37232 United States
  • US Oncology and Research
  • Fort Worth Texas 76177 United States
  • VCU Massey Cancer Center
  • Richmond Virginia 23298 United States
  • Southern Medical Day Care Centre
  • Wollongong New South Wales 2500 Australia
  • Austin Health-Austin Hospital
  • Heidelberg Victoria 3084 Australia
  • Adelaide Cancer Centre
  • Kurralta Park 5037 Australia
  • Macquarie University Hospital
  • Macquarie Park 2109 Australia
  • London Health Sciences Centre
  • London Ontario N6A 4L6 Canada
  • The Ottawa Hospital Cancer Centre
  • Ottawa Ontario K1H 8L6 Canada
  • Sunnybrook Research Institute
  • Toronto Ontario M4N 3M5 Canada
  • CIUSSS - Hopital Maisonneuve- Rosemont
  • Montréal Quebec H1T 2M4 Canada
  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
  • Québec Quebec G1R 3S1 Canada
  • Aalborg University Hospital
  • Aalborg 9000 Denmark
  • Aarhus Universitetshospital
  • Aarhus 8000 Denmark
  • Rigshospitalet
  • Copenhagen 2100 Denmark
  • Herlev Hospital
  • Herlev 2730 Denmark
  • Institut de Cancerologie de l Ouest Site Paul Papin
  • Angers 49055 France
  • Clinique Sainte Catherine
  • Avignon 84918 France
  • Centre de Lutte Contre le Cancer Francois Baclesse
  • Caen 14000 France
  • Clinique Victor Hugo
  • Le Mans 72000 France
  • Centre Oscar Lambret
  • Lille 59020 France
  • Centre Leon Berard
  • Lyon 69008 France
  • Institut du Cancer de Montpellier
  • Montpellier 34298 France
  • Hopital Cochin
  • Paris 75014 France
  • Hopital Saint Louis
  • Paris 75475 France
  • Institut Jean Godinot
  • Reims 51726 France
  • Centre Medico-Chirurgical Foch
  • Suresnes 92151 France
  • C.H.U. de Tours - Hopital Bretonneau
  • Tours 37044 France
  • Institut Gustave Roussy
  • Villejuif 94805 France
  • Universitaetsklinikum Schleswig-Holstein. Campus Luebeck
  • Luebeck Schleswig Holstein 23538 Germany
  • Universitaetsklinikum Duesseldorf
  • Duesseldorf 40225 Germany
  • Universitatsklinikum Hamburg-Eppendorf
  • Hamburg 20246 Germany
  • Universitaetsklinikum Jena
  • Jena 07747 Germany
  • Universitaetsklinikum Magdeburg A.o.R.
  • Magdeburg 39120 Germany
  • Klinikum rechts der Isar der Technischen Universitat
  • Muenchen 81675 Germany
  • Universitaetsklinikum Tuebingen
  • Tuebingen 72076 Germany
  • Orszagos Onkologiai Intezet
  • Budapest 1122 Hungary
  • Uzsoki Utcai Korhaz
  • Budapest 1145 Hungary
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Kaposvár 7400 Hungary
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Miskolc 3526 Hungary
  • Pecsi Tudomanyegyetem AOK
  • Pécs 7624 Hungary
  • Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet
  • Szolnok 5004 Hungary
  • Cork University Hospital
  • Cork Ireland
  • Beaumont Hospital
  • Dublin 00009 Ireland
  • Adelaide & Meath Hospital (Incl NCH)
  • Dublin 00024 Ireland
  • University College Hospital Galway
  • Galway H91YR71 Ireland
  • University Hospital Limerick
  • Limerick Ireland
  • Waterford Regional Hospital
  • Waterford X91ER8E Ireland
  • Soroka Medical Center
  • Be'er Sheva 8410101 Israel
  • Rambam Medical Center
  • Haifa 31096 Israel
  • Meir Medical Center
  • Kfar Saba 4428164 Israel
  • Rabin Medical Center
  • Petach-Tikwa 49100 Israel
  • Chaim Sheba Medical Center
  • Ramat Gan 52621 Israel
  • Sourasky Medical Center
  • Tel Aviv 6423906 Israel
  • Assaf Harofeh Medical Center
  • Zerifin 70300 Israel
  • Medical Oncology Ospedale San Donato
  • Arezzo 52100 Italy
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Meldola 47014 Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milano 20133 Italy
  • Istituto Nazionale Tumori Fondazione Pascale
  • Napoli 80131 Italy
  • Istituto Oncologico Veneto
  • Padova 35128 Italy
  • Nagoya University Hospital
  • Nagoya Aichi 466-8560 Japan
  • Nara Medical University Hospital
  • Kashihara Nara 634-8522 Japan
  • Yamaguchi University Hospital
  • Ube Yamaguchi 755-8505 Japan
  • Medical Hospital, Tokyo Medical And Dental University
  • Tokyo 113-8519 Japan
  • Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC)
  • Tokyo 144-0042 Japan
  • Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC)
  • Tokyo 144-0042 Japan
  • Seoul National University Hospital
  • Seoul 03080 Korea, Republic of
  • Severance Hospital Yonsei University Health System
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Samsung Medical Center
  • Seoul 06351 Korea, Republic of
  • Antoni van Leeuwenhoek Ziekenhuis
  • Amsterdam 1066 CX Netherlands
  • VU University Medical Center
  • Amsterdam 1081 HV Netherlands
  • Amphia Ziekenhuis
  • Breda 4819 EV Netherlands
  • Catharina Ziekenhuis
  • Eindhoven 5623 EJ Netherlands
  • University Medical Center Groningen
  • Groningen 9713 GZ Netherlands
  • Leningrad Regional Oncology Dispensary
  • Saint Petersburg Leningrad Region, Vsevolozhsky District 188663 Russian Federation
  • Ivanovo Regional Oncology Dispensary
  • Ivanovo 153013 Russian Federation
  • N.N. Blokhin NMRCO
  • Moscow 115478 Russian Federation
  • Russian Scientific Center of Roentgenoradiology
  • Moscow 117997 Russian Federation
  • National Medical Research Radiological Centre
  • Moscow 125284 Russian Federation
  • Ryazan Regional Clinical Oncology Dispensary
  • Ryazan' 390046 Russian Federation
  • Pokrovskaya City Hospital
  • Saint Petersburg 199106 Russian Federation
  • Clinic of Bashkortostan State Medical University
  • Ufa 450000 Russian Federation
  • Hospital del Mar
  • Barcelona 08003 Spain
  • Hospital Vall D Hebron
  • Barcelona 08035 Spain
  • Hospital de la Santa Creu i Sant Pau
  • Barcelona 08041 Spain
  • Hospital General Universitario Gregorio Maranon
  • Madrid 28007 Spain
  • MD Anderson Cancer Center Madrid
  • Madrid 28033 Spain
  • Hospital Universitario Virgen de la Victoria
  • Málaga 29010 Spain
  • Hospital Clinico Universitario de Santiago
  • Santiago De Compostela 15706 Spain
  • Instituto Valenciano de Oncologia
  • Valencia 46009 Spain
  • Chang Gung Medical Foundation. Kaohsiung Branch
  • Kaohsiung 833 Taiwan
  • China Medical University Hospital
  • Taichung 40447 Taiwan
  • National Cheng Kung University Hospital
  • Tainan 704 Taiwan
  • National Taiwan University Hospital
  • Taipei 100 Taiwan
  • Taipei Veterans General Hospital
  • Taipei 11217 Taiwan
  • Adana Numune Egitim ve Arastirma Hastanesi
  • Adana 01358 Turkey
  • Adana Sehir Hastanesi
  • Adana 01370 Turkey
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH
  • Ankara 06200 Turkey
  • Akdeniz Universitesi Tip Fakultesi
  • Antalya 07059 Turkey
  • Pamukkale Unv. Tip Fak.
  • Denizli 20070 Turkey
  • Trakya Universitesi Tip Fakultesi
  • Edirne 22030 Turkey
  • Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi
  • Istanbul 34899 Turkey
  • Dokuz Eylul University Faculty of Medicine
  • İzmir 35340 Turkey
  • Samsun Medical Park Hastanesi
  • Samsun 55200 Turkey
  • Royal Marsden NHS Trust
  • Sutton Surrey SM2 5PT United Kingdom
  • Queen Elizabeth Hospital
  • Birmingham B15 2TH United Kingdom
  • Barts Health NHS Trust - St Bartholomew s Hospital
  • London EC1A 7BE United Kingdom
  • Royal Free London NHS Foundation Trust
  • London NW3 2QG United Kingdom
  • Imperial College Healthcare NHS Trust
  • London W6 8RF United Kingdom
  • Plymouth Hospitals NHS Trust
  • Plymouth PL6 8DH United Kingdom
  • Sunderland Royal Hospital
  • Sunderland SR4 7TP United Kingdom

View trial on ClinicalTrials.gov


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A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)


Condition: UC (Urothelial Cancer)

Intervention:

  • Drug: Pembrolizumab
  • Drug: Epacadostat
  • Drug: Placebo

Purpose: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03361865

Sponsor: Incyte Corporation

Primary Outcome Measures:

  • Measure: Progression-free survival (PFS) with pembrolizumab + epacadostat versus pembrolizumab + placebo
  • Time Frame: Up to 36 months
  • Safety Issue:
  • Measure: Overall survival (OS) with pembrolizumab + epacadostat versus pembrolizumab + placebo
  • Time Frame: Up to 36 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Number of participants experiencing adverse events (AEs) compared between pembrolizumab + epacadostat versus pembrolizumab + placebo [Safety and Tolerability]
  • Time Frame: Up to 39 months
  • Safety Issue:
  • Measure: Number of participants discontinuing study treatment due to AEs compared between pembrolizumab + epacadostat versus pembrolizumab + placebo [Safety and Tolerability]
  • Time Frame: Up to 39 months
  • Safety Issue:
  • Measure: Objective response rate with pembrolizumab + epacadostat versus pembrolizumab + placebo
  • Time Frame: Approximately 24 months
  • Safety Issue:
  • Measure: Mean change from baseline in global health status/quality of life scales
  • Time Frame: Up to 25 months
  • Safety Issue:
  • Measure: Time to true deterioration (TTD)
  • Time Frame: Up to 25 months
  • Safety Issue:

Estimated Enrollment: 650

Study Start Date: December 22, 2017

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
  • Measurable disease based on RECIST v1.1.
  • Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.
  • Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
  • Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization.
  • Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

  • Disease that is suitable for local therapy administered with curative intent.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
  • Known history of or is positive for active hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  • History of a gastrointestinal condition that in the opinion of the Investigator may affect oral drug absorption.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
  • Use of protocol-defined prior/concomitant therapy.

Contact:

  • Incyte Corporation Call Center (US)
  • 1.855.463.3463

Locations:

  • Arizona Oncology Associates PC- HOPE
  • Tucson Arizona 85704 United States
  • University of California Irvine Medical Center
  • Orange California 92868 United States
  • Yale Cancer Center
  • New Haven Connecticut 06511 United States
  • Woodlands Medical Specialists, PA
  • Pensacola Florida 32503 United States
  • Rush University Medical Center
  • Chicago Illinois 60612 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89169 United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • New York New York 10016 United States
  • Levine Cancer Institute
  • Charlotte North Carolina 28204 United States
  • Willamette Valley Cancer Institute and Research Center
  • Eugene Oregon 97401 United States
  • Abramson Cancer Center of the University of Pennsylvania
  • Philadelphia Pennsylvania 19104 United States
  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111 United States
  • Medical University of South Carolina-Hollings Cancer Center
  • Charleston South Carolina 29425 United States
  • Tennessee Oncology-Chattanooga
  • Chattanooga Tennessee 37404 United States
  • University of Tennessee Medical Center Knoxville
  • Knoxville Tennessee 37920 United States
  • Tennessee Oncology Nashville
  • Nashville Tennessee 37203 United States
  • Vanderbilt-Ingram Cancer Center
  • Nashville Tennessee 37232 United States
  • Texas Oncology PA
  • Houston Texas 77024 United States
  • Calvary Mater Newcastle
  • Waratah New South Wales 2298 Australia
  • Southern Medical Day Care Centre
  • Wollongong New South Wales 2500 Australia
  • Austin Health-Austin Hospital
  • Heidelberg Victoria 3084 Australia
  • Adelaide Cancer Centre
  • Kurralta Park 5037 Australia
  • Macquarie University Hospital
  • Macquarie Park 2109 Australia
  • Institut Jules Bordet
  • Bruxelles 1000 Belgium
  • Grand Hopital de Charleroi - Site Notre Dame - Oncology
  • Charleroi 6000 Belgium
  • AZ Maria Middelares Gent
  • Gent 9000 Belgium
  • Universitair Ziekenhuis Gent
  • Gent 9000 Belgium
  • Hopital de Jolimont
  • Haine-Saint-Paul 7100 Belgium
  • AZ Nikolaas
  • Sint-Niklaas 9100 Belgium
  • GZA Sint Augustinus
  • Wilrijk 2610 Belgium
  • Moncton Hospital - Horizon Health Network
  • Moncton New Brunswick E1C 6Z8 Canada
  • Cancer Centre of Southeastern Ontario at Kingston General Hospital
  • Kingston Ontario K7L 2V7 Canada
  • Ottawa General Hospital
  • Ottawa Ontario K1H 8L6 Canada
  • Sunnybrook Health Science Centre
  • Toronto Ontario M4N 3M5 Canada
  • CIUSSS - Hopital Maisonneuve-Rosemont
  • Montreal Quebec H1T 2M4 Canada
  • CHU de Quebec - Hotel-Dieu de Quebec
  • Québec Quebec G1R 2J6 Canada
  • Institut de Cancerologie de l Ouest Site Paul Papin
  • Angers 49055 France
  • CHU de Besancon
  • Besançon 25030 France
  • Institut Bergonie
  • Bordeaux 33076 France
  • Centre Jean Perrin
  • Clermont-Ferrand 63011 France
  • Institut Paoli Calmettes
  • Marseille 13009 France
  • Centre d Oncologie de Gentilly
  • Nancy 54100 France
  • Hopital Europeen Georges Pompidou
  • Paris 75908 France
  • Centre Hospitalier Lyon Sud
  • Pierre-Bénite 69310 France
  • Institut Jean Godinot
  • Reims 51726 France
  • CHU de Strasbourg - Nouvel Hopital Civil
  • Strasbourg 67091 France
  • Institut Claudius Regaud
  • Toulouse 31059 France
  • C.H.U. de Tours - Hopital Bretonneau
  • Tours 37044 France
  • Institut Gustave Roussy
  • Villejuif 94805 France
  • Universitaetsklinikum Schleswig-Holstein. Campus Luebeck
  • Luebeck Schleswig Holstein 23538 Germany
  • Universitaetsklinikum Duesseldorf
  • Duesseldorf 40225 Germany
  • Kliniken Essen Mitte
  • Essen 45136 Germany
  • Universitatsklinikum Hamburg-Eppendorf
  • Hamburg 20246 Germany
  • Universitaetsklinikum Jena
  • Jena 07747 Germany
  • Universitaetsklinikum Magdeburg A.o.R.
  • Magdeburg 39120 Germany
  • Klinikum rechts der Isar der Technischen Universitat
  • Muenchen 81675 Germany
  • Krankenhaus der Barmherzigen Brueder Trier
  • Trier 54292 Germany
  • Universitaetsklinikum Tuebingen
  • Tuebingen 72076 Germany
  • Cork University Hospital
  • Cork Ireland
  • Adelaide & Meath Hospital (Incl NCH)
  • Dublin 00024 Ireland
  • University College Hospital Galway
  • Galway H91YR71 Ireland
  • University Hospital Limerick
  • Limerick V94 F858 Ireland
  • University Hospital Waterford
  • Waterford X91ER8E Ireland
  • Soroka Medical Center
  • Be'er Sheva 8410101 Israel
  • Rambam Health Care Campus
  • Haifa 31096 Israel
  • Meir Medical Center
  • Kfar Saba 4428164 Israel
  • Rabin Medical Center
  • Petach-Tikwa 49100 Israel
  • Chaim Sheba Medical Center
  • Ramat Gan 52621 Israel
  • Sourasky Medical Center
  • Tel Aviv 6423906 Israel
  • Assaf Harofeh Medical Center
  • Zerifin 70300 Israel
  • Medical Oncology Ospedale San Donato
  • Arezzo 52100 Italy
  • Istituto Tumori Giovanni Paolo II
  • Bari 70124 Italy
  • Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST
  • Meldola 47014 Italy
  • Istituto Nazionale dei Tumori
  • Milan 20133 Italy
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Napoli 80131 Italy
  • Istituto Oncologico Veneto
  • Padova 35128 Italy
  • Nagoya University Hospital
  • Nagoya Aichi 466-8560 Japan
  • National Cancer Center Hospital East
  • Kashiwa Chiba 277-8577 Japan
  • University of Tsukuba Hospital
  • Tsukuba Ibaraki 305-8576 Japan
  • Nara Medical University Hospital
  • Kashihara Nara 634-8522 Japan
  • Kindai University Hospital
  • Osakasayama Osaka 589-8511 Japan
  • Yamaguchi University Hospital
  • Ube Yamaguchi 755-8505 Japan
  • Tokushima University Hospital
  • Tokushima 770-8503 Japan
  • Medical Hospital, Tokyo Medical And Dental University
  • Tokyo 113-8519 Japan
  • The Cancer Institute Hospital of JFCR
  • Tokyo 135-8550 Japan
  • Chungnam National University Hospital
  • Daejeon 35015 Korea, Republic of
  • Seoul National University Hospital
  • Seoul 03080 Korea, Republic of
  • Severance Hospital Yonsei University Health System
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Samsung Medical Center
  • Seoul 06351 Korea, Republic of
  • Amphia Ziekenhuis
  • Breda Brabant 4819EV Netherlands
  • Antoni van Leeuwenhoek Ziekenhuis
  • Amsterdam 1066 CX Netherlands
  • VU University Medical Center
  • Amsterdam 1081 HV Netherlands
  • Catharina Ziekenhuis
  • Eindhoven 5623 EJ Netherlands
  • University Medical Center Groningen
  • Groningen 9713 GZ Netherlands
  • Erasmus MC
  • Rotterdam 3075 EA Netherlands
  • Beskidzkie Centrum Onkologii im. Jana Pawla II
  • Bielsko-Biala 43-300 Poland
  • Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
  • Jelenia Góra 58-506 Poland
  • Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego
  • Katowice 40-514 Poland
  • Europejskie Centrum Zdrowia Otwock
  • Otwock 05-400 Poland
  • Urologica Praktyka Lekarska Adam Marcheluk
  • Siedlce 08-110 Poland
  • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
  • Szczecin 70-111 Poland
  • Magodent Szpital Elblaska
  • Warszawa 01-748 Poland
  • Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne
  • Warszawa 02 616 Poland
  • Leningrad Regional Oncology Dispensary
  • Saint Petersburg Leningrad Region, Vsevolozhsky District 188663 Russian Federation
  • Ivanovo Regional Oncology Dispensary
  • Ivanovo 153013 Russian Federation
  • N.N. Blokhin NMRCO
  • Moscow 115478 Russian Federation
  • Russian Scientific Center of Roentgenoradiology
  • Moscow 117997 Russian Federation
  • National Medical Research Radiological Centre
  • Moscow 125284 Russian Federation
  • Ryazan Regional Clinical Oncology Dispensary
  • Ryazan 390046 Russian Federation
  • Pokrovskaya City Hospital
  • Saint Petersburg 199106 Russian Federation
  • Clinic of Bashkortostan State Medical University
  • Ufa 450000 Russian Federation
  • Hospital Teresa Herrera - Chuac
  • A Coruña 15006 Spain
  • Hospital Infanta Cristina
  • Badajoz 06080 Spain
  • Hospital General Universitari Vall d Hebron
  • Barcelona 08035 Spain
  • ICO L Hospitalet
  • Hospitalet de Llobregat 08908 Spain
  • Hospital Lucus Augusti
  • Lugo 27003 Spain
  • Xarxa Assistencial Universitaria Manresa
  • Manresa 08243 Spain
  • Consorci Hospitalari Parc Tauli de Sabadell
  • Sabadell 08208 Spain
  • Hospital Virgen del Rocio
  • Sevilla 41013 Spain
  • Taipei Veterans General Hospital
  • Taipei Beitou 112 Taiwan
  • Chang Gung Medical Foundation - Kaohsiung
  • Kaohsiung 833 Taiwan
  • China Medical University Hospital
  • Taichung 40447 Taiwan
  • National Cheng Kung University Hospital
  • Tainan 704 Taiwan
  • National Taiwan University Hospital
  • Taipei 100 Taiwan
  • MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov
  • Dnipropetrovsk 49005 Ukraine
  • Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC
  • Dnipropetrovsk 49102 Ukraine
  • Kharkiv Regional Clinical Oncology Center
  • Kharkiv 61000 Ukraine
  • Kyiv City Clinical Oncology Center
  • Kyiv 03115 Ukraine
  • MI Odessa Regional Oncological Centre
  • Odesa 65055 Ukraine
  • RMI Sumy Regional Clinical Oncology Dispensary
  • Sumy 40022 Ukraine
  • Royal Marsden NHS Trust
  • Sutton Surrey SM2 5PT United Kingdom
  • Beatson Institute of Cancer Research
  • Glasgow G120YN United Kingdom
  • Barts Health NHS Trust - St Bartholomew's Hospital
  • London EC1A 7BE United Kingdom
  • Royal Free London NHS Foundation Trust
  • London NW3 2QG United Kingdom
  • Imperial College Healthcare NHS Trust
  • London W6 8RF United Kingdom
  • Plymouth Hospitals NHS Trust
  • Plymouth PL6 8DH United Kingdom
  • Sunderland Royal Hospital
  • Sunderland SR4 7TP United Kingdom

View trial on ClinicalTrials.gov


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A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)


Condition: Renal Cell Carcinoma (RCC)

Intervention:

  • Drug: Pembrolizumab
  • Drug: Epacadostat
  • Drug: Sunitinib
  • Drug: Pazopanib

Purpose: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with clear cell component who have not received prior systemic therapy for their mRCC.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03260894

Sponsor: Incyte Corporation

Primary Outcome Measures:

  • Measure: Progression-free survival of pembrolizumab + epacadostat versus standard of care (SOC)
  • Time Frame: Up to 30 months
  • Safety Issue:
  • Measure: Overall survival of pembrolizumab + epacadostat versus SOC
  • Time Frame: Up to 60 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective response rate of pembrolizumab + epacadostat versus SOC
  • Time Frame: Up to 36 months
  • Safety Issue:
  • Measure: Duration of response of pembrolizumab + epacadostat versus SOC
  • Time Frame: Up to 36 months
  • Safety Issue:
  • Measure: Safety and tolerability of pembrolizumab + epacadostat versus SOC as measured by number of participants experiencing adverse events (AEs)
  • Time Frame: Up to 39 months
  • Safety Issue:
  • Measure: Safety and tolerability of pembrolizumab + epacadostat versus SOC as measured by number of participants discontinuing study drug due to AEs
  • Time Frame: Up to 39 months
  • Safety Issue:
  • Measure: Health-related quality of life (HRQoL) of pembrolizumab + epacadostat versus SOC as measured by time to deterioration (TTD)
  • Time Frame: Up to 36 months
  • Safety Issue:
  • Measure: HRQoL of pembrolizumab + epacadostat versus SOC as measured by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life scale
  • Time Frame: Up to 42 weeks
  • Safety Issue:
  • Measure: HRQoL of pembrolizumab + epacadostat versus SOC as measured by European Quality of Life (EuroQol) EQ-5D™ 3 level version (EQ 5D-3L) assessment
  • Time Frame: Up to 36 months
  • Safety Issue:

Estimated Enrollment: 630

Study Start Date: December 7, 2017

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
  • Must not have received any prior systemic therapy for their mRCC.
  • Measurable disease based on RECIST v1.1.
  • Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
  • Karnofsky performance status ≥ 70%.
  • Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

  • Use of protocol-defined prior/concomitant therapy.
  • Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
  • History of severe hypersensitivity reaction to study treatments or their excipients.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Known additional malignancy that has progressed or has required active treatment in the last 3 years.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
  • History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
  • Significant cardiac event within 12 months before Cycle 1 Day 1.

Contact:

  • Incyte Corporation Call Center (US)
  • 1.855.463.3463

Locations:

  • Pinnacle Oncology Hematology
  • Scottsdale Arizona 85258 United States
  • Arizona Oncology Associates PC- HOPE
  • Tucson Arizona 85711 United States
  • Cedars-Sinai Medical Center
  • Los Angeles California 90048 United States
  • UC Irvine Comprehensive Cancer Center
  • Orange California 92868 United States
  • UC Davis Comprehensive Cancer Center
  • Sacramento California 95817 United States
  • Atlanta Cancer Care - Conyers
  • Conyers Georgia 30094 United States
  • Northwest Georgia Oncology Centers Pc
  • Marietta Georgia 30060 United States
  • Rush University Medical Center
  • Chicago Illinois 60612 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Southeast Nebraska Hematology & Oncology Consultants, P.C.
  • Lincoln Nebraska 68510 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Levine Cancer Institute
  • Charlotte North Carolina 28204 United States
  • University of Tennessee Erlanger Oncology & Hematology
  • Chattanooga Tennessee 37403 United States
  • The West Clinic, P.C.
  • Germantown Tennessee 38138 United States
  • US Oncology and Research
  • The Woodlands Texas 77380 United States
  • Utah Cancer Specialists
  • Salt Lake City Utah 84106 United States
  • Huntsman Cancer Institute
  • Salt Lake City Utah 84112 United States
  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Roanoke Virginia 24014 United States
  • Shenandoah Oncology, P.C.
  • Winchester Virginia 22601 United States
  • Seattle Cancer Care Alliance
  • Seattle Washington 98019 United States
  • Canberra Hospital
  • Garran Australian Capital Territory 2605 Australia
  • Calvary Mater Newcastle
  • Waratah New South Wales 2298 Australia
  • Westmead Hospital
  • Westmead New South Wales 2145 Australia
  • Cabrini Health
  • Malvern Victoria 3144 Australia
  • Fiona Stanley Hospital
  • Murdoch 6150 Australia
  • Centro de pesquisa Porto Alegre
  • Porto Alegre Florianopolis 90610-000 Brazil
  • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Barretos Sao Paulo 14784-400 Brazil
  • Instituto do Cancer de Sao Paulo - ICESP
  • São Paulo Sao Paulo 01246-000 Brazil
  • Hospital Sao Jose
  • São Paulo Sao Paulo 01321-001 Brazil
  • Centro Avancado de Tratamento Oncologico - CENANTRON -
  • Belo Horizonte 30130090 Brazil
  • Hospital de Clinicas de Porto Alegre
  • Porto Alegre 90035-903 Brazil
  • Tom Baker Cancer Centre
  • Calgary Alberta T2N 4N2 Canada
  • Kingston Health Sciences Centre - KGH Site
  • Kingston Ontario K7L 2V7 Canada
  • Sunnybrook Health Sciences, Odette Cancer Centre
  • Toronto Ontario M4N 3M5 Canada
  • CHUM - Hopital Notre-Dame
  • Montreal Quebec H2L 4M1 Canada
  • Jewish General Hospital
  • Montréal Quebec H3T 1E2 Canada
  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
  • Quebec G1R 2J6 Canada
  • Clinica Alemana de Osorno
  • Osorno Region De Los Lagos 5311089 Chile
  • Fundacion Arturo Lopez Perez FALP
  • Santiago 7500921 Chile
  • Pontificia Universidad Catolica de Chile
  • Santiago 8320000 Chile
  • Hospital Clinico Vina del Mar
  • Vina del Mar 2520612 Chile
  • Centre Antoine Lacassagne
  • Nice Cedex 2 06189 France
  • CHU Besancon - Hopital Jean Minjoz
  • Besançon 25030 France
  • Hopital Saint Andre
  • Bordeaux 33075 France
  • Centre Francois Baclesse
  • Caen 14076 France
  • Hopital Prive Toulon Hyeres Sainte Marguerite
  • Hyeres 83400 France
  • Hopital Europeen Georges Pompidou
  • Paris 75015 France
  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Pierre Benite 69495 France
  • Clinique Sainte Anne
  • Strasbourg 67000 France
  • CHU de Strasbourg - Nouvel Hopital Civil
  • Strasbourg 67091 France
  • Institut Gustave Roussy
  • Villejuif 94805 France
  • Helios Klinikum Berlin Buch
  • Berlin 13125 Germany
  • Universitaetsklinikum der Technischen Universitaet Dresden
  • Dresden 01307 Germany
  • Universitaetsklinikum Essen. Klinik und Poliklinik fuer Urologie
  • Essen 45147 Germany
  • Universitaetsklinikum Frankfurt
  • Frankfurt am Main 60590 Germany
  • Medizinische Hochschule Hannover
  • Hannover 30625 Germany
  • Universitaetsklinikum Jena
  • Jena 07747 Germany
  • Universitaetsklinikum Magdeburg. Klinik fuer Urologie
  • Magdeburg 39120 Germany
  • Universitaetsklinikum Tuebingen
  • Tuebingen 72076 Germany
  • Orszagos Onkologiai Intezet
  • Budapest Pest 1122 Hungary
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Kaposvar 7400 Hungary
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Miskolc 3526 Hungary
  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
  • Szolnok 5000 Hungary
  • Markusovszky Egyetemi Oktatokorhaz
  • Szombathely 9700 Hungary
  • Zala Megyei Szent Rafael Korhaz
  • Zalaegerszeg 8900 Hungary
  • Adelaide & Meath Hospital
  • Dublin 00024 Ireland
  • University Hospital Waterford
  • Waterford X91ER8E Ireland
  • National Cancer Center Hospital East
  • Kashiwa Chiba 277-8577 Japan
  • Sapporo Medical University Hospital
  • Sapporo Hokkaido 060-8543 Japan
  • Hokkaido University Hospital
  • Sapporo Hokkaido 060-8648 Japan
  • Nara Medical University Hospital
  • Kashihara Nara 634-8522 Japan
  • Kindai University Hospital
  • Osakasayama Osaka 589-8511 Japan
  • Yamaguchi University Hospital
  • Ube Yamaguchi 755-8505 Japan
  • Niigata University Medical & Dental Hospital
  • Niigata 951-8520 Japan
  • Toranomon Hospital
  • Tokyo 105-8470 Japan
  • Nippon Medical School Hospital
  • Tokyo 113-8603 Japan
  • Keio University Hospital
  • Tokyo 160-8582 Japan
  • Chonnam National University Hwasun Hospital
  • Hwasun Jeollanam Do 58128 Korea, Republic of
  • Severance Hospital Yonsei University Health System
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Samsung Medical Center
  • Seoul 06351 Korea, Republic of
  • Auckland City Hospital
  • Auckland Grafton 1023 New Zealand
  • Helse Bergen HF Haukeland sykehus
  • Bergen 5053 Norway
  • Sykehuset Oestfold
  • Gralum 1714 Norway
  • Sorlandet sykehus HF
  • Kristiansand 4615 Norway
  • Akershus University Hospital
  • Lørenskog 1478 Norway
  • Oslo universitetssykehus
  • Oslo 0450 Norway
  • Universitetssykehuset i Nord Norge. Kreftavdelingen
  • Tromsø 9019 Norway
  • St Olavs Hospital
  • Trondheim 7030 Norway
  • Ivanovo regional oncology dispensary
  • Ivanovo 153040 Russian Federation
  • Russian Scientific Center of Roentgenoradiology
  • Moscow 117997 Russian Federation
  • Central Hospital with Out-patient Clinic of Pres Aff Dept
  • Moscow 121359 Russian Federation
  • National Medical Research Radiology Centre
  • Moscow 125284 Russian Federation
  • Bashkortostan Republican Clinical Oncology Dispensary
  • Ufa 450054 Russian Federation
  • Hospital Parc Tauli
  • Sabadell Barcelona 08208 Spain
  • Hospital Germans Trias i Pujol
  • Badalona 08916 Spain
  • Hospital del Mar
  • Barcelona 08003 Spain
  • Hospital General Universitario Gregorio Maranon
  • Madrid 28007 Spain
  • Hospital Universitario HM Sanchinarro
  • Madrid 28050 Spain
  • Hospital Clinico Universitario de Santiago
  • Santiago de Compostela 15706 Spain
  • Instituto Valenciano de Oncologia
  • Valencia 46009 Spain
  • Chang Gung Med Foundation. Kaohsiung Branch
  • Kaohsiung 833 Taiwan
  • China Medical University Hospital
  • Taichung 40447 Taiwan
  • National Cheng Kung University Hospital
  • Tainan 70457 Taiwan
  • National Taiwan University Hospital
  • Taipei 10048 Taiwan
  • Taipei Veterans General Hospital
  • Taipei 112 Taiwan
  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
  • Adana 01250 Turkey
  • Ankara Numune Education and Research Hospital
  • Ankara 06100 Turkey
  • Hacettepe University Medical Faculty
  • Ankara 06100 Turkey
  • Istanbul Universitesi Onkoloji Enstitusu
  • Istanbul 34093 Turkey
  • Istanbul Medeniyet Universitesi Goztepe EAH
  • Istanbul 34732 Turkey
  • Ege Universitesi Tıp Fakultesi
  • Izmir 35040 Turkey
  • Namik Kemal Universitesi Tip Fakultesi
  • Tekirdag 59100 Turkey
  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council
  • Kryvyi Rih Dnipropetrovsk Region 50048 Ukraine
  • Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov
  • Dnipropetrovs'k 49005 Ukraine
  • Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC
  • Dnipropetrovs'k 49102 Ukraine
  • MI Precarpathian Clinical Oncology Center
  • Ivano-Frankivs'k 76018 Ukraine
  • RMI Sumy Regional Clinical Oncology Dispensary
  • Sumy 40022 Ukraine
  • The Royal Marsden NHS Foundation Trust.
  • Sutton Surrey SM2 5PT United Kingdom
  • Western General Hospital
  • Edinburgh EH4 2XU United Kingdom
  • Beatson Institute of Cancer Research
  • Glasgow G12 0YN United Kingdom
  • Barts Health NHS Trust - St Bartholomew s Hospital
  • London EC1A 7BE United Kingdom
  • The Royal Marsden Foundation Trust
  • London SW3 6JJ United Kingdom
  • The Christie NHS Foundation Trust
  • Manchester MB204BX United Kingdom

View trial on ClinicalTrials.gov


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A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer


Condition: Urothelial Cancer

Intervention:

  • Biological: nivolumab
  • Biological: ipilimumab
  • Drug: gemcitabine
  • Drug: cisplatin
  • Drug: carboplatin

Purpose: The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating patients with previously untreated inoperable or metastatic urothelial cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03036098

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Progression free survival (PFS) in cisplatin-ineligible participants using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Time Frame: Up to 42 months
  • Safety Issue:
  • Measure: Overall survival (OS) of cisplatin-ineligible participants
  • Time Frame: Up to 42 months
  • Safety Issue:
  • Measure: PFS based on BICR assessment of nivolumab combined with standard of care (SOC) chemotherapy to SOC chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic Urothelial Cancer (UC)
  • Time Frame: Up to 42 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression free survival (PFS) in all participants using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Time Frame: Up to 42 months
  • Safety Issue:
  • Measure: Overall survival (OS) in all participants
  • Time Frame: Up to 42 months
  • Safety Issue:
  • Measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Global Health Status score
  • Time Frame: Up to 42 months
  • Safety Issue:
  • Measure: OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC.
  • Time Frame: Up to 42 months
  • Safety Issue:

Estimated Enrollment: 897

Study Start Date: March 24, 2017

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Metastatic or inoperable urothelial cancer
  • Must have at least 1 lesion with measurable disease
  • Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
  • No prior systemic chemotherapy treatment in the metastatic setting Exclusion Criteria:
  • Patients with disease that is suitable for local therapy administered with curative intent
  • Patients with active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol defined inclusion/

Exclusion Criteria:

  • Patients with disease that is suitable for local therapy administered with curative intent
  • Patients with active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 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
  • Birmingham Alabama 35223 United States
  • Local Institution
  • Birmingham Alabama 35233 United States
  • Alaska Urological Institute dba Alaska Clinical Research Center
  • Anchorage Alaska 99503 United States
  • Local Institution
  • Little Rock Arkansas 72205 United States
  • VA of Central California Health Care System
  • Fresno California 93703 United States
  • St Joseph Heritage Healthcare
  • Santa Rosa California 95403 United States
  • Local Institution
  • Boca Raton Florida 33486 United States
  • Holy Cross Hospital
  • Fort Lauderdale Florida 33308 United States
  • Cancer Specialists of North FL
  • Jacksonville Florida 32207 United States
  • University Cancer Blood Ctr
  • Athens Georgia 30607 United States
  • Lewis Hall Singletary Oncology Center
  • Thomasville Georgia 31792 United States
  • Local Institution
  • Chicago Illinois 60612 United States
  • Local Institution
  • Iowa City Iowa 55242 United States
  • Ochsner Clinic
  • New Orleans Louisiana 70121 United States
  • Beth Israel Deaconess Med Ctr
  • Boston Massachusetts 02215 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Local Institution
  • Milford Massachusetts 01757 United States
  • Local Institution
  • South Weymouth Massachusetts 02190 United States
  • St. Joseph Mercy Hospital
  • Ypsilanti Michigan 48197 United States
  • Ridges Cancer Clinic
  • Burnsville Minnesota 55337 United States
  • Hattiesburg Clinic
  • Hattiesburg Mississippi 39401 United States
  • St Lukes Hospital
  • Kansas City Missouri 64111 United States
  • Washington University School Of Medicine
  • Saint Louis Missouri 63110 United States
  • Local Institution
  • Omaha Nebraska 68130 United States
  • Nh Hematology - Oncology
  • Hooksett New Hampshire 03106 United States
  • University Of New Mexico
  • Albuquerque New Mexico 87131 United States
  • Local Institution
  • Buffalo New York 14263 United States
  • Winthrop University Hospital
  • Mineola New York 11501 United States
  • Icahn School Of Medicine At Mount Sinai
  • New York New York 10029 United States
  • Local Institution
  • New York New York 10065 United States
  • Local Institution
  • Durham North Carolina 27710 United States
  • Local Institution
  • Columbus Ohio 43210 United States
  • Providence Portland Med Ctr
  • Portland Oregon 97213 United States
  • Allegheny General Hospital
  • Pittsburgh Pennsylvania 15212-0000 United States
  • Local Institution
  • Houston Texas 77030 United States
  • Local Institution
  • Salt Lake City Utah 84112 United States
  • Seattle Cancer Care Alliance
  • Kirkland Washington 98034 United States
  • Local Institution
  • Milwaukee Wisconsin 53226 United States
  • Instituto Medico Especializado Alexander Fleming
  • Capital Federal Buenos Aires 1426 Argentina
  • Local Institution
  • Mar Del Plata Buenos Aires 7600 Argentina
  • Clinica Viedma S.A.
  • Viedma RIO Negro 8500 Argentina
  • Centro De Diagnostico Urologico S.R.L.
  • Buenos Aires 1120 Argentina
  • Local Institution
  • Cordoba 5000 Argentina
  • Local Institution
  • Cordoba X5004FHP Argentina
  • Local Institution
  • Darlinghurst New South Wales 2010 Australia
  • Local Institution
  • Westmead New South Wales 2145 Australia
  • Local Institution
  • Chermside Queensland 4032 Australia
  • Local Institution
  • Tugun Queensland 4224 Australia
  • Local Institution
  • Heidelberg Victoria 3084 Australia
  • Local Institution
  • Doubleview Western Australia 6018 Australia
  • Local Institution
  • Brasilia Distrito Federal 70200-730 Brazil
  • Local Institution
  • Ijui RIO Grande DO SUL 98700-000 Brazil
  • Local Institution
  • Passo Fundo RIO Grande DO SUL 99010-080 Brazil
  • Local Institution
  • Porto Alegre RIO Grande DO SUL 90610-000 Brazil
  • Local Institution
  • Florianopolis Santa Catarina 88034-000 Brazil
  • Local Institution
  • Barretos SAO Paulo 14780-070 Brazil
  • Local Institution
  • Sao Jose do Rio Preto SAO Paulo 15090-000 Brazil
  • Local Institution
  • Sao Paulo 01509-900 Brazil
  • Nova Scotia Health Authority QEII Health Sciences Centre
  • Halifax Nova Scotia B3H 2Y9 Canada
  • London Regional Cancer Program, London Health Sciences Centre
  • London Ontario N6A 4L6 Canada
  • Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
  • Sherbrooke Quebec J1H 5N4 Canada
  • Local Institution
  • Quebec G1R 2J6 Canada
  • Local Institution
  • Santiago Metropolitana Chile
  • Centro Internacional de Estudios Clinicos
  • Recoleta Santiago DE Chile Chile
  • Hospital Clinico Vina Del Mar
  • Vina Del Mar Valparaiso 2520612 Chile
  • Local Institution
  • Vitacura Chile
  • Local Institution
  • Brno 656 53 Czechia
  • Local Institution
  • Hradec Kralove 500 05 Czechia
  • Local Institution
  • Aalborg 9100 Denmark
  • Local Institution
  • Herlev 2730 Denmark
  • Local Institution
  • Helsinki 00029 Finland
  • Local Institution
  • Lille 59000 France
  • Local Institution
  • Marseille Cedex 9 13273 France
  • Local Institution
  • Nimes Cedex 09 30029 France
  • Local Institution
  • Saint Priest En Jarez 42271 France
  • Local Institution
  • Suresnes 92151 France
  • Local Institution
  • Tours Cedex 37044 France
  • Local Institution
  • Villejuif 94805 France
  • Universitat Dresden
  • Dresden 01307 Germany
  • Universitaetsklinikum Essen
  • Essen 45147 Germany
  • Medizinische Universitaetsklinik Freiburg
  • Freiburg 79106 Germany
  • Asklepios Klinik Altona
  • Hamburg 22763 Germany
  • Medizinische Hochschule Hannover
  • Hannover 30625 Germany
  • Universitaetsklinikum Jena
  • Jena 07747 Germany
  • Local Institution
  • Muenchen 81675 Germany
  • Klinikum Nuernberg Nord, Urologische Klinik
  • Nuernberg 90419 Germany
  • Uniklinik Tuebingen
  • Tuebingen 72076 Germany
  • Kliniken Nordoberpfalz AG
  • Weiden 92637 Germany
  • Univ. Klinikum Wuerzburg
  • Wuerzburg 97080 Germany
  • Local Institution
  • Athens 11528 Greece
  • Local Institution
  • Ioannina 45500 Greece
  • Local Institution
  • Budapest 1122 Hungary
  • Local Institution
  • Budapest 1145 Hungary
  • Local Institution
  • Debrecen Hungary
  • Local Institution
  • Miskolc 3526 Hungary
  • Local Institution
  • Kfar Saba 44281 Israel
  • Local Institution
  • Ramat Gan 52621 Israel
  • Local Institution
  • Arezzo 52100 Italy
  • Local Institution
  • Forli 47014 Italy
  • Local Institution
  • Grosseto 58100 Italy
  • IRCCS Istituto Nazionale Tumori
  • Milano 20133 Italy
  • Local Institution
  • Napoli 80131 Italy
  • Local Institution
  • Hirosaki-shi Aomori 036-8563 Japan
  • Local Institution
  • Chiba-shi Chiba 260-8717 Japan
  • Local Institution
  • Matsuyama-shi Ehime 7910280 Japan
  • Local Institution
  • Fukuoka-shi Fukuoka 8128582 Japan
  • Local Institution
  • Sapporo-city Hokkaido 0608543 Japan
  • Local Institution
  • Tsukuba-shi Ibaraki 3058576 Japan
  • Local Institution
  • Kita-Gun Kagawa 7610793 Japan
  • Local Institution
  • Niigata-shi Niigata 9518520 Japan
  • Local Institution
  • Okayama-shi Okayama 7008558 Japan
  • Local Institution
  • Osaka-shi Osaka 5418567 Japan
  • Local Institution
  • Osakasayama Osaka 589-8511 Japan
  • Local Institution
  • Takatsuki-shi Osaka 5698686 Japan
  • Local Institution
  • Hamamatsu-shi Shizuoka 431-3192 Japan
  • Local Institution
  • Arakawa-ku,tokyo Tokyo 1168567 Japan
  • Local Institution
  • Bunkyo-ku Tokyo 1138519 Japan
  • Local Institution
  • Bunkyo-ku Tokyo 1138602 Japan
  • Local Institution
  • Shinjuku-Ku Tokyo 1608582 Japan
  • Local Institution
  • Ube City Yamaguchi 755-8505 Japan
  • Local Institution
  • Goyang-si 10408 Korea, Republic of
  • Local Institution
  • Seongnam-si 13620 Korea, Republic of
  • Local Institution
  • Seoul 03080 Korea, Republic of
  • Local Institution
  • Seoul 03722 Korea, Republic of
  • Local Institution
  • Seoul 05505 Korea, Republic of
  • Local Institution
  • Seoul 06351 Korea, Republic of
  • Comite Mexicano para la Prevenion de la Osteoporosis A.C.
  • Ciudad de Mexico Distrito Federal 06100 Mexico
  • Local Institution
  • Mexico City Distrito Federal 07760 Mexico
  • Local Institution
  • Tlalpan Distrito Federal 14080 Mexico
  • Local Institution
  • Monterrey Nuevo LEON 64460 Mexico
  • Local Institution
  • Amsterdam 1066 CX Netherlands
  • Local Institution
  • Enschede 7512KZ Netherlands
  • Local Institution
  • Groningen 9713 AP Netherlands
  • Local Institution
  • Leeuwarden 8934 AD Netherlands
  • Instituto Nacional De Enfermedades Neoplasicas
  • Lima 34 Peru
  • Clinica El Golf
  • Lima Lima 27 Peru
  • Local Institution
  • Bydgoszcz 85-796 Poland
  • Local Institution
  • Warszawa 02-781 Poland
  • Local Institution
  • Cluj-Napoca 400015 Romania
  • Local Institution
  • Craiova 200347 Romania
  • Local Institution
  • Moscow 115478 Russian Federation
  • Local Institution
  • Moscow 117997 Russian Federation
  • Local Institution
  • St Petersburg 198255 Russian Federation
  • Local Institution
  • Singapore 169610 Singapore
  • Local Institution
  • A Coruna 15006 Spain
  • Local Institution
  • Barcelona 08025 Spain
  • Local Institution
  • Madrid 28034 Spain
  • Local Institution
  • Madrid 28041 Spain
  • Local Institution
  • Sevilla 41013 Spain
  • Local Institution
  • Valencia 46009 Spain
  • Local Institution
  • Jonkoping 551 85 Sweden
  • Local Institution
  • Linkoping 581 85 Sweden
  • Local Institution
  • Lund 221 85 Sweden
  • Kantonsspital Baden
  • Baden 5404 Switzerland
  • Kantonsspital Graubuenden
  • Chur 7000 Switzerland
  • Local Institution
  • Kaohsiung 883 Taiwan
  • Local Institution
  • Taichung 40705 Taiwan
  • Local Institution
  • Taipei 100 Taiwan
  • Local Institution
  • Taipei 11217 Taiwan
  • Local Institution
  • Taoyuan 333 Taiwan
  • Local Institution
  • Ankara 06590 Turkey
  • Local Institution
  • Istanbul 34300 Turkey
  • Local Institution
  • Izmir 35340 Turkey

View trial on ClinicalTrials.gov


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