Kidney/Renal Cancer

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ERICA: Phase 2 Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell Carcinoma


Condition: Renal Cell Carcinoma, Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03562507

Sponsor: University of Michigan Rogel Cancer Center

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologic diagnosis of renal cell carcinoma (any histology except medullary carcinoma or collecting duct carcinoma is acceptable) with radiologic or histologic evidence of metastatic disease.
  • Prior treatment with up to one (and only one) anti-VEGF or VEGFR inhibitor (small molecule or antibody).
  • Must have measurable disease as per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) criteria.
  • Must be of age ≥ 18 years at time of informed consent.
  • Ability to understand and the willingness to sign a written informed consent.
  • Karnofsky Performance Status ≥60. (The Karnofsky Performance Status Scale is an assessment tool for functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. In most serious illnesses, the lower the Karnofsky score, the worse the likelihood of survival.)
  • Most recent systemic therapy or most recent radiation therapy ≥ 2 weeks of first study drug dose.
  • Recovery to baseline or < Grade 1 CTCAE v.4.03 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 28 days prior to registration.
  • Adequate organ and marrow function

Exclusion Criteria:

  • Prior treatment for metastatic disease with >1 anti-VEGF/VEGFR inhibitor.
  • Prior treatment with anti-PD/PD-L1/CTLA4/IDO antibody or ESK981.
  • Prior mTOR inhibitors or glutaminase inhibitors are allowed.
  • Untreated brain metastases or spinal cord compression.
  • Uncontrolled hypertension defined as blood pressure >150/90 despite at least 2 anti-hypertensive medication(s) as assessed by 2 blood pressure readings taken at least 1 hour apart during screening.
  • Major surgical procedure or significant traumatic injury within 6 weeks prior to study registration (> 6 weeks prior to registration is permitted as long as they have fully recovered from any such procedure).
  • History of another primary malignancy except for: malignancy treated with curative intent and no known active disease for ≥2 years, adequately treated non-melanoma skin cancer without current evidence of active disease, adequately treated carcinoma in situ without current evidence of active disease, Gleason ≤6 prostate cancer.
  • Angina, myocardial infarction symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous angioplasty or coronary arterial bypass surgery within the past 3 months.
  • History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved (e.g. through surgical resection or repair).
  • The patient has known hypersensitivity to gelatin or lactose monohydrate.
  • The patient has received any investigational drug within 28 days prior to registration or 5 half-lives of the investigational drug, whichever is shorter.
  • History of bleeding disorders (e.g. pulmonary hemorrhage, significant hemoptysis, menometrorrhagia not responding to hormonal treatment) ≤ 6 weeks before Cycle 1 Day1.
  • The patient is on a chronic daily medication known to be a severe or moderate inhibitor or inducer by Micromedex of CYP1A2, CYP2C8, or CYP3A4 at registration.
  • Systemic corticosteroids greater than the equivalent of 10 mg of prednisone or equivalent alternative steroid (except physiologic dose for adrenal replacement therapy) or other immunosuppressive agents (such as cyclosporine or methotrexate) and any other medications that could potentially impact the efficacy or safety of the study as judged by the treating investigator are NOT permitted from time of registration to subjects completing protocol therapy unless clinically indicated to manage adverse events or life threatening or serious conditions as determined by the treating investigator.
  • Have any condition that, in the opinion of the investigator, would compromise the ability of the subject to meet or perform study requirements.

View trial on ClinicalTrials.gov


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Phase I/II Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03172754

Sponsor: Fox Chase Cancer Center

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced RCC with predominantly clear cell subtype.
  • Archival tumor biospecimen (when available) must be procured for correlative evaluation. If tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study.
  • Formalin fixed, paraffin embedded [FFPE] tissue block(s) or at least 12 unbaked, unstained slides are required. Tissue samples taken from a metastatic lesion prior to the start of screening are acceptable.
  • At least one measureable lesion as defined by RECIST version 1.1.
  • Age > 18 years.
  • ECOG performance status 0 or 1
  • Adequate bone marrow, kidney, and liver function as defined by: WBC ≥ 2000/μL. Neutrophils ≥ 1500/μL. Platelets ≥ 100 x103/μL. Hemoglobin > 9.0 g/dL. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula): Female CrCl = (140
  • age in years) x (weight in kg x 0.85)/(72 x serum creatinine in mg/dL). Male CrCl = (140
  • age in years) x (weight in kg x 1.00)/(72 x serum creatinine in mg/dL). AST/ALT ≤ 3 x ULN. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).
  • No evidence of pre-existing uncontrolled hypertension as documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart. The baseline systolic BP readings must be ≤ 150 mm Hg, and the baseline diastolic BP readings must be ≤ 90 mm Hg
  • Patients enrolled to the prior treatment arm of the expansion cohort must have been exposed to a TKI for metastatic disease. Exposure to TKI as part of (neo)adjuvant treatment that completed within 1 year of study qualifies as prior exposure as well.

Exclusion Criteria:

  • Prior therapy with axitinib
  • Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to the expansion cohort, treatment naïve arm. If prior (neo)adjuvant treatment given as part of a clinical trial, this would be allowed as long as last dose was > 1 year prior to start of treatment
  • Patients enrolled to the prior treatment arm of the dose escalation cohort must not have received anti-cancer therapy less than 14 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • Patients are excluded if they have active, symptomatic brain metastases or leptomeningeal metastases. Subjects with known brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for four weeks (after treatment is complete and within 28 days prior to study drug administration.
  • Second malignancy requiring active systemic treatment
  • Diagnosis of immunodeficiency
  • Active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Patients have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Major surgery <4 weeks or radiation therapy <2 weeks of study entry. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
  • Gastrointestinal abnormalities including: Inability to take oral medication; Requirement for intravenous alimentation; Prior surgical procedures affecting absorption including total gastric resection; Treatment for active peptic ulcer disease in the past 6 months; Active gastrointestinal bleeding as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; Malabsorption syndromes.
  • Evidence of inadequate wound healing.
  • Active bleeding disorder or other history of significant bleeding episodes within 30 days before study entry.
  • Known prior or suspected hypersensitivity to study drugs or any component in their formulations.
  • Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice. The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.
  • Current use or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort.
  • As there is potential for hepatic toxicity with nivolumab, drugs with a predisposition to hepatotoxicity should be used with caution in patients treated with nivolumab-containing regimen.
  • Known hepatitis B virus (HBV) or hepatitis C virus (HBV) infection.
  • Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • History of any of the following cardiovascular conditions within 12 months of screening: Myocardial infarction, Unstable angina pectoris, Cardiac angioplasty or stenting, Coronary/peripheral artery bypass graft, Class III or IV congestive heart failure per New York Heart Association, Cerebrovascular accident or transient ischemic attack
  • History of deep vein thrombosis or pulmonary embolism within 6 months of screening. Patients who are currently taking anticoagulation therapy for a prior history (> 6 months from screening) of thrombosis may still be eligible.
  • Pregnant or breast feeding.

View trial on ClinicalTrials.gov


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Pilot Study of Renal Neoplasms With Perfusion Magnetic Resonance Imaging


Condition: Stage I Renal Cell Cancer, Stage II Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02526511

Sponsor: Rutgers, The State University of New Jersey

Eligibility:

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

Inclusion Criteria:

  • Patients must be able to read, understand, and voluntarily sign an informed consent document
  • For patients with organ confined renal tumors to be enrolled, the renal mass must be >= 1 cm in diameter on computed tomography (CT) or magnetic resonance imaging (MRI) and can be any clinical stage T1a-T4 (non-metastatic); a histologic diagnosis is not required for enrollment; the primary imaging site would be kidney
  • For patients with metastatic renal tumors to be enrolled, a histologic diagnosis of renal cell carcinoma must exist and any burden of disease >= 1 cm by CT or MRI is acceptable; the metastatic sites may be kidney, intra-abdominal (such as liver), brain, bone, or lymph nodes; lung lesions are NOT eligible because of the motion artifact caused by respiration
  • Patients with metastatic disease may have received prior nephrectomy and/or prior systemic therapy (no limit on number); their baseline pMRI would be performed prior to starting a new treatment
  • Negative pregnancy test if female of child-bearing age
  • Able to undergo contrast enhanced MRI

Exclusion Criteria:

  • Severe concurrent disease, infection, or medical co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment
  • Severe renal function impairment (estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73 m^2) would make the patient inappropriate for enrollment due to the increased risk of nephrogenic systemic fibrosis (NSF) with higher dose of IV gadolinium-based contrast agents (GBCA) administration
  • Women who are pregnant or breastfeeding
  • Subjects who are unable to tolerate or are not eligible for MR imaging (claustrophobia, metal implantable devices such as pacemaker, aneurysm clips, etc)
  • Subjects with established allergy to IV GBCA

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A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups


Condition: Metastatic Renal Cell Carcinoma, Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Unresectable Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03595124

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

  • Age: minimum 12 Months maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patients must have a body surface area (BSA) >= 0.53 m^2
  • Histologically confirmed unresectable or metastatic translocation morphology renal cell carcinoma diagnosed using World Health Organization (WHO)-defined criteria. Patients may be newly diagnosed or have received prior cancer therapy
  • Patients must have had histologic verification of the malignancy
  • Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
  • Patients must have a tumor showing the appropriate morphologic appearance, and either confirmed TFE3 nuclear protein expression by immunohistochemistry with appropriate positive and negative controls performed at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, or evidence of TFE3 or TFEb translocation by either fluorescence in situ hybridization (FISH) or reverse transcriptase- polymerase chain reaction (RT-PCR) performed at a CLIA-certified laboratory. For TFE3 immunohistochemistry, any nuclear positivity in the presence of appropriate positive and negative controls should be considered as evidence of TFE3 immunohistochemical expression. NOTE: If the institution is unable to perform these studies, unstained slides may be submitted to Dr. Elizabeth Perlman, who will perform TFE3 analysis at no charge. The slide will be returned to the referring institution for local evaluation, to be included in their institutional report
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients must have a life expectancy of >= 8 weeks
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
  • Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (6 weeks if prior nitrosourea)
  • Immunotherapy: Must not have received within 4 weeks of entry onto this study
  • Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent
  • Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL (performed within 7 days prior to enrollment)
  • Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment)
  • Urine protein: =< 30 mg/dL in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hours (h) urine sample (performed within 7 days prior to enrollment)
  • For patients < 18 years of age: Serum creatinine =< 1.5 x upper limit of normal (ULN), or measured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 for patient with creatinine levels > 1.5 x institutional ULN, or a serum creatinine based on age/gender as follows (performed within 7 days prior to enrollment):
  • 1 to < 2 years
  • 0.6 mg/dL (male, female)
  • 2 to < 6 years
  • 0.8 mg/dL (male, female)
  • 6 to < 10 years
  • 1 mg/dL (male, female)
  • 10 to < 13 years
  • 1.2 mg/dL (male, female)
  • 13 to < 16 years
  • 1.5 mg/dL (male), 1.4 mg/dL (female)
  • >= 16 years
  • 1.7 mg/dL (male), 1.4 mg/dL (female)
  • Creatinine clearance should be calculated per institutional standard
  • For patients >= 18 years of age: Serum creatinine =< 2 x ULN, or measured or calculated creatinine clearance or radioisotope GFR >= 40 mL/min/1.73 m^2 for patient with creatinine levels > 2 x institutional ULN (performed within 7 days prior to enrollment)
  • Creatinine clearance should be calculated per institutional standard
  • Serum total bilirubin =< 1.5 x ULN for age, or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 X ULN (performed within 7 days prior to enrollment)
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN for age (performed within 7 days prior to enrollment)
  • Albumin > 2.5 mg/dL (performed within 7 days prior to enrollment)
  • Shortening fraction of >= 27% by echocardiogram, or
  • Ejection fraction of >= 50% by radionuclide angiogram
  • No history of myocardial infarction, severe or unstable angina, or peripheral vascular disease
  • Corrected QT (QTc) =< 480 msec. Note: Patients with grade 1 prolonged QTc (450-480 msec) at the time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications)
  • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN. However, if patient is receiving anticoagulant therapy, PT or partial thromboplastin time (PTT) should be within therapeutic range of intended use of anticoagulants
  • Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • A baseline blood pressure (BP) =< the 95th percentile for age, height, and gender for patients < 18 years old, or =< 150 mmHg (systolic) and =< 90 mmHg (diastolic) for patients >= 18 years old
  • Note: 2 serial blood pressures should be taken at least 1 hour apart and averaged to determine baseline BP
  • Patients are eligible if on stable doses (>= 7 days) of anti-hypertensive medications with a baseline BP meeting the criteria above

Exclusion Criteria:

  • Patients unable to swallow whole tablets
  • Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible
  • Prior Therapy
  • Patients who have received prior therapy with axitinib, nivolumab, or other PD1/PD-L1 targeted therapies
  • Patients who have received prior therapy with more than one anti VEGF based agent (antibody or tyrosine kinase inhibitor)
  • Patients with hypersensitivity to axitinib, nivolumab, or any of its excipients
  • Patients who previously received an allogeneic stem cell transplant (SCT) or solid organ transplant are not eligible
  • Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)
  • Patients who have received prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study enrollment or who have not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks prior to enrollment
  • Surgery: Patients who have had or who are planning to have the following invasive procedures are not eligible:
  • Major surgical procedure, laparoscopic procedure, open biopsy, core biopsy, fine needle aspirate, or significant traumatic injury within 7 days prior to enrollment. NOTE: External central lines must be placed at least 3 days prior to planned treatment initiation and subcutaneous ports must be placed at least 7 days prior to planned treatment initiation
  • Patients who are planning cytoreductive surgery within the first 12 weeks following therapy initiation
  • Patients who have a serious or non-healing wound or ulcer at the time of study enrollment are not eligible
  • Patients who have a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment are not eligible
  • Patients who have received prior targeted small molecule therapy within 2 weeks of enrollment or have not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks prior to enrollment. NOTE: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
  • Pre-existing conditions, which may include:
  • Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer
  • Patients with underlying immune deficiency, chronic infections including hepatitis, tuberculosis (TB), or autoimmune disease
  • Human immunodeficiency virus (HIV)-infected patients with the exception of patients on an effective anti-retroviral therapy with an undetectable viral load within 6 months prior to enrollment
  • Patients with underlying hematologic issues including congenital bleeding diathesis, known previous gastrointestinal (GI) bleeding requiring intervention within the past 6 months, history of hemoptysis within 42 days prior to study enrollment, active pulmonary emboli, or deep vein thromboses (DVT) that are not stable on anticoagulation regimen
  • Patients must not have had significant vascular disease (i.e. Moya-Moya, aortic aneurysm requiring surgical repair)
  • A known history of, or any evidence of active, non-infectious pneumonitis
  • Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study enrollment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study enrollment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
  • Any uncontrolled, intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
  • Any serious medical or psychiatric illness/condition including substance use disorders likely in the judgment of the investigator(s) to interfere or limit compliance with study requirements/treatment
  • Patients with active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Treatments and/or medications the patient is receiving or has received that would make her/him ineligible, including:
  • Concomitant (or receipt of) treatment with medications that may affect the metabolism of nivolumab and/or axitinib within 7 days prior to planned first dose of protocol therapy
  • A live vaccine within 30 days of planned first dose of protocol therapy. NOTE: Inactivated flu vaccines are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
  • Pregnancy and breast feeding
  • Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of study drug
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of study therapy
  • Male patients of reproductive potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy. Prior history of vasectomy does not replace requirement for contraceptive use
  • Regulatory requirements
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

View trial on ClinicalTrials.gov


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Endoscopic Robot-Assisted Simple Enucleation Versus Standard Robot-Assisted Partial Nephrectomy in the Treatment of T1 Renal Cell Carcinoma: A Non-inferiority Randomized Controlled Trial


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03624673

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: All

Inclusion Criteria:

  1. patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
  2. ECOG score <=1
  3. RENAL score <=9
  4. patients with normal contralateral renal function
  5. patients giving consent to the participation in the current clinical trial

Exclusion Criteria:

  1. intolerance of robotic surgery
  2. metastastic renal cell carcinoma
  3. RENAL score >=10
  4. entry into collection system or hematuria
  5. patients with a history of other renal diseases, such as urinary lithiasis
  6. patients with a history of renal surgery

View trial on ClinicalTrials.gov


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A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic Renal Cell Cancer


Condition: Renal Cell Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03876925

Sponsor: Sunshine Lake Pharma Co., Ltd.

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

Inclusion Criteria:

  • Histologically or cytologically confirmed renal cell cancer.Patients must be diagnosed with advanced or metastatic disease,disease progressed to previous treatment .
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • Toxicity recovered to NCI CTCAE v.4.03 Grade ≤1 from previous treatments (except alopecia)
  • ECOG performance status (PS) 0 or 1
  • Life expectancy of ≥ 12 weeks
  • Adequate organ function
  • Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion Criteria:

  • Chemotherapy,radiotherapy,immunotherapy and targeted therapy less than 4 months prior to administration.
  • Symptomatic, untreated or unstable central nervous system metastases
  • Uncontrolled hypertension that require anti-hypertensive agents to control, or systolic blood pressure (BP) >140mmHg or diastolic BP >90 mmHg before the first administration (BP is the mean blood pressure of two measures that 1 hours interval or above)
  • Doppler ultrasound evaluation:Left ventricular ejection fraction < 50%
  • Significantly clinical arrhythmia or symptomatic bradycardia, or male with QTCF > 450 ms or female with QTCF > 470 ms, or patients with a history of torsion or congenital QT prolonged syndrome long QT syndrome
  • Certain factors that would preclude adequate absorption of CT053PTSA and gefitinib (eg. unable to swallow, chronic diarrhea, intestinal obstruction)
  • Patients with evidence of bleeding tendency, including the following cases: gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above; or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator
  • History of organ transplantation
  • Any disease of the following bellowed within 12 months prior to administration: Myocardial infarction, severe angina, or unstable angina, coronary or peripheral artery bypass graft, congestive heart failure
  • Pulmonary embolism or cerebrovascular events (including transient ischemic attack)within 6 months prior to administration
  • Infection of HIV
  • Patients with infection of HBV or HCV. Patients with positive of HBsAg or HBcAb,and HBV-DNA can be measured (>500IU/ml). Patients with positive of anti-HCV,and HCV-RNA can be measured by PCR.
  • Other malignancies within 5 years prior to enrollment, with the exception of carcinoma in situ of the cervix, basal or squamous cell skin cancer
  • Pregnant or lactating woman
  • Any other reason the investigator considers the patient is not suitable to participate in the study

View trial on ClinicalTrials.gov


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Denosumab and Pembrolizumab in Clear Cell Renal Carcinoma: a Phase II Trial (ANZUP 1601)


Condition: Renal Cell Carcinoma, Clear Cell, Metastatic Kidney Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03280667

Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Adults, aged 18 years and older, with histologically confirmed unresectable or metastatic renal cell carcinoma with a clear cell component
  • Disease progression during or after VEGFR TKI treatment
  • At least 1 target lesion according to RECIST v1.1
  • ECOG performance status of 0-2
  • Adequate bone marrow function (done within 14 days prior to registration
  • Haemoglobin ≥ 90g/L
  • Platelet ≥ 75x109/L
  • Neutrophil count ≥ 1.5x109/L
  • Adequate liver function (done within 14 days prior to registration and with values within the ranges specified below):
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome
  • AST or ALT ≤ 3.0 x ULN (or ≤ 5.0x ULN in the presence of liver metastases)
  • Adequate renal function (done within 14 days prior to registration and with values within the ranges specified below):
  • Creatinine ≤ 1.5x ULN OR
  • Creatinine clearance (CrCl) ≥ 30mL/min
  • Serum calcium or albumin-adjusted serum calcium ≥2.0 mmol/L
  • Tumour tissue available for tertiary correlative studies
  • Willing and able to start treatment within 14 days of registration, and to comply with all study requirements, including the timing and/or nature of the required treatment and assessments
  • Signed, written informed consent

Exclusion Criteria:

  • Prior treatment with pembrolizumab, or with any other anti-PD-1, anti-PD-L1, Anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Any condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone or equivalent dose of alternative corticosteroid) or other immunosuppressive medications within 14 days of pembrolizumab administration. Intranasal, inhaled or topical steroids are permitted in the absence of active autoimmune disease.
  • Prior treatment with denosumab.
  • Untreated brain or leptomeningeal metastases or current clinical or radiological progression of known brain metastases, or requirement for steroid therapy for brain metastases. Patients with treated brain metastases are eligible if they have been stable and off steroids for ≥ 3 weeks.
  • Prior allogeneic organ transplant, inflammatory bowel disease, pneumonitis, tuberculosis, or primary immunodeficiency
  • Active infection requiring systemic therapy within 14 days before the first dose of pembrolizumab
  • Receipt of live attenuated vaccination within 30 days of the planned first dose of pembrolizumab
  • Active dental or jaw condition that precludes administration of denosumab: i) Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, or; ii) Active dental or jaw condition which requires oral surgery, or; iii) Non-healed dental/oral surgery, or; iv) Planned invasive dental procedures during the course of the study
  • Clinically significant hypersensitivity to denosumab or any components of denosumab
  • Targeted small molecule therapy, surgery or radiation therapy within 2 weeks before registration, or persisting adverse event(s) of Grade 2 or more due to a previously administered agent. Note that participants who have had recent major surgery must have recovered adequately before registration.
  • Life expectancy of less than 3 months.
  • History of an active malignancy within the previous 5 years, except for locally curable cancers that have been apparently cured, such as low-grade thyroid carcinoma, prostate cancer not requiring treatment (Gleason grade ≤ 6), basal or squamous cell skin cancer, superficial bladder cancer, melanoma in situ, or carcinoma in situ of the prostate, cervix, or breast. Patients who have been free of other malignancies for ≥ 5 years prior to registration are eligible for this study.
  • Significant infection, including chronic active hepatitis B, hepatitis C, or HIV.
  • Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
  • Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception. Subject is excluded if pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment. Female subject of child bearing potential is excluded if they are not willing to use, in combination with her partner, highly effective contraception during treatment and for 5 months after the end of treatment.

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Single Arm Phase Ib/II Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer: Big Ten Cancer Research Consortium BTCRC-GU16-043


Condition: Advanced Kidney Cancer, Kidney Cancer, Clear Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03308396

Sponsor: Ajjai Alva, MD

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • Subject must meet all of the following applicable inclusion criteria to participate in this study:
  • Written informed consent and HIPAA authorization for release of personal health information.
  • ECOG Performance Status 0-1 within 28 days prior to registration.
  • Histological diagnosis of clear cell renal cell carcinoma (pure or mixed) with radiologic or histologic evidence of metastatic disease.
  • At least 1 lesion, not previously irradiated that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have a short axis ≥ 15mm) with a computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements as per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) guidelines.
  • For cohort 1, subjects may have received up to 1 and no more than 1 prior line of systemic therapy (not counting any neoadjuvant/adjuvant therapy) including anti-VEGF, VEGFR inhibitor, MET inhibitor or mTOR inhibitor for metastatic disease. They cannot have received any prior anti-PD-1/PD-L1/CTLA4 therapy including durvalumab.
  • For cohort 2, subjects may have received up to 2 prior systemic therapies which should include 1 (and only 1) prior anti-PD-1/PD-L1 therapy but did not have an objective response to the prior anti-PD-1/Pd-L1 therapy. The treating investigator must document that the patient did not have an objective response to prior anti-PD-1/PD-L1 therapy. They may have received prior anti-CTLA4 therapy.
  • Subjects may not have had radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
  • Prior cancer treatment must be completed at least 14 days prior to study registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤Grade 1 or baseline.
  • Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to registration: Hematological:
  • White blood cell (WBC) ≥ 3 K/mm^3
  • Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm^3
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Platelets (Plt) ≥ 100,000/mm^3 Renal:
  • Calculated creatinine clearance ≥ 40 cc/min using the Cockcroft-Gault formula Hepatic:
  • Bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) ≤ 2.5 × ULN
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN
  • Females of childbearing potential must have a negative serum pregnancy test within 28 days prior to registration.
  • Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use at least 1 highly effective methods of contraception from the time of informed consent until 30 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.
  • Life expectancy ≥ 12 weeks (in the opinion of the Investigator)
  • Body weight >30kg
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

  • Subjects meeting any of the criteria below may not participate in the study:
  • Active infection requiring systemic therapy.
  • Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry. Patients whose brain metastases have been treated may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration provided they show radiographic stability (defined as 1 brain image, obtained after treatment to the brain metastases). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable without the use of steroids for at least 14 days prior to the start of treatment.
  • Pregnant or breastfeeding
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease.
  • Treatment with any investigational drug within 14 days prior to study registration.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]) within the last 3 years prior to study registration. The following are exceptions to this criterion: The following are exceptions to this criterion:
  • Subjects with vitiligo or alopecia.
  • Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
  • Any chronic skin condition that does not require systemic therapy.
  • Subjects without active disease in the last 5 years may be included but only after consultation with the study physician.
  • Subjects with celiac disease controlled by diet alone.
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection).
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
  • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca/ MedImmune staff and/or staff at the study site).
  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • Any concurrent chemotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable (e.g., local surgery or radiotherapy).
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to study registration. Note: local surgery of isolated lesions for palliative intent is acceptable.
  • History of allogenic organ transplantation that requires use of immunosuppressive agents.
  • Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • History of leptomeningeal carcinomatosis.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug. Note: patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of study drug.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of study drug.
  • Known allergy or hypersensitivity to study drugs or other humanized monoclonal antibodies.
  • Patient ≤30kg in weight.
  • Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction.
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:
  • Subjects with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
  • Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.

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Genetic Evaluation of Renal Cell Carcinoma; Predicting Biomarkers for Renal Cell Carcinoma


Condition: Kidney Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03414827

Sponsor: Zealand University Hospital

Phase:

Eligibility:

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

Inclusion Criteria:

  • Patients who have been diagnosed with kidney cancer.

Exclusion Criteria:

  • Patients without signs of malignancy at final histology report.
  • Incapacitated patients.

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Targeting PIM1 and CDK4/6 Kinases in Renal Cell Carcinoma (PICKRCC): A Phase Ib Study of Abemaciclib (VerzenioTM) in Combination With Sunitinib in Metastatic Renal Cell Carcinoma


Condition: Renal Cell Carcinoma Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03905889

Sponsor: Milton S. Hershey Medical Center

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  1. Has histologic or cytologic evidence of metastatic renal cell carcinoma with histology predominantly (>50%) clear cell renal cell carcinoma solid neoplasm.
  2. Has evidence of metastatic disease. Intermediate and poor risk patients according to International Metastatic Renal Cell Carcinoma Database criteria (IMDC) must have received prior combination ipilimumab and nivolumab therapy and subsequently experienced disease progression, or been offered ipilimumab and nivolumab combination therapy and refused, or be ineligible for combination ipilimumab and nivolumab therapy. Patients with favorable risk disease have no eligibility requirement for prior use of ipilimumab and nivolumab immunotherapy.
  3. Intermediate and poor risk patients (according to IMDC criteria) must also have received prior cabozantinib therapy and subsequently experienced disease progression, or been offered cabozantinib therapy and refused, or be ineligible for cabozantinib therapy. Patients with favorable risk disease have no eligibility requirement for prior use of cabozantinib. Cytoreductive nephrectomy is allowed but not mandatory.
  4. Has in the opinion of the investigator, a predicted life expectancy of more than 3 months.
  5. Has presence of at least 1 lesion that is measurable or evaluable using RECIST v1.
  6. This is defined in at least one dimension as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT, MRI or calipers by clinical exam
  7. Has either archival tissue for analysis or will require confirmation of disease with fresh biopsy. Tissue will not be required pre/post treatment for biomarker analysis.
  8. Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or
  9. Patients with central nervous system metastases must have received surgical and/or radiation treatment, the metastases must be neurologically stable, and patients must be off corticosteroids or receiving a stable low-dose regimen of corticosteroids (i.e., a daily dose of 10 mg or less of prednisone or equivalent) for at least 4 weeks prior to the first dose of study drug.
  10. Has completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy, at least 3-4 weeks from prior VEGFR/mTOR/ or immunotherapy or any other tyrosine kinase inhibitor (TKI) therapy, and at least 4 weeks for treatment with investigational drugs
  11. Must be able to swallow capsules and tablets.
  12. Has adequate organ function (i.e. lung, liver, kidney, bone marrow), as evidenced by multiple laboratory value results within specific parameters.
  13. Women of childbearing potential (WOCP) as defined as not surgically sterile or not postmenopausal) must have a negative result for a serum pregnancy test before study drug administration on cycle 1 day
  14. WOCP must use a medically accepted method of contraception and must agree to continue use this method for the duration of the study and for 30 days after discontinuation of study drug.
  15. If male, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the study (and for 30 days after taking the last dose of study drug because of the possible effects on spermatogenesis).

Exclusion Criteria:

  1. Predominately non-clear cell renal cell carcinoma histology (i.e. >50%)
  2. Has had chemotherapy within 4 weeks or radiotherapy within 1 week prior to first dose of study drug or those who have not recovered from toxicities due to agents administered more than 4 weeks earlier.
  3. Has ongoing or active infection requiring parenteral antibiotics.
  4. Has uncontrolled hypertension despite adequate therapy (i.e., systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
  5. Has diabetes mellitus with occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
  6. Has an active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers for which they are treated with curative intent, and no known active disease in the 3 years prior to enrollment.
  7. Has a primary brain tumor or has brain metastases from a non-renal cell cancer.
  8. Has a QTcF interval greater than 470 msec, has a known history of QTcF prolongation, or has a history of torsade de pointes.
  9. Has a known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
  10. Has a known history of pulmonary fibrosis or any other restrictive lung disorder.
  11. Has any other concurrent conditions including a medical, psychiatric, or social condition that, in the opinion of the investigator, could preclude the patient's participation in the study, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to, patients with congestive heart failure (New York Heart Association [NYHA] Class III or IV), cardiac arrhythmia, or acute coronary syndromes within 6 months of enrollment.
  12. Has used an investigational drug within 4 weeks prior to first dose of study drug or is currently participating in another investigational study.
  13. Has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery or bariatric surgery).
  14. Has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Abemaciclib or Sunitinib.
  15. Has previous use of a CDK4/6 kinase inhibitor (eg. ribociclib, palbociclib)
  16. Has previous use of a PIM1 kinase inhibitor

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CABRAMET: A Phase 2 Study of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases


Condition: Metastatic Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03967522

Sponsor: Centre Leon Berard

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • I1. Age ≥ 18 years. I2. Histologically proven metastatic Renal Cell Carcinoma. I3. Brain metastases not requiring corticosteroids at dose > 40 mg/day. I4.At least 1 brain lesion ≥8mm in longest diameter or >5mm if > 1 lesion. I5.Not previously treated by cabozantinib. I6.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1. I7.Life expectancy ≥ 3 months I8.Adequate organ function as defined by the following criteria:
  • Total serum bilirubin ≤ 2 x ULN (Gilbert's disease exempted)
  • Serum transaminases and alkaline phosphatases ≤ 2.5 x ULN, or in case of liver or bone metastasis ≤ 5.0 x ULN
  • Serum creatinine ≤ 2 x ULN, creatinine clearance ≥ 50 ml/min
  • Absolute neutrophil count (ANC) ≥ 1 500/mm3
  • Platelets ≥ 100 000/mm3 (100 G/l)
  • Hemoglobin ≥ 9.0 g/dl. I9. Covered by a medical/health insurance. I10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. I11. Signed and dated IRB/ICE approved informed consent form. I12. Accepting to use effective contraception (barrier contraceptives) during study treatment and within at least 4 months after final dose of study therapy. Oral contraceptives are not acceptable.

Exclusion Criteria:

  1. E
  2. Any local previous treatment of current brain metastases. E
  3. Any anti-coagulation therapy (except preventive treatment at low dose). E
  4. Contra-indication of Magnetic Resonance Imaging (MRI) (i.e. : pace-maker). E
  5. Uncontrolled seizures. E
  6. Any symptoms of intracranial hypertension. E
  7. Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, ischemic or hemorrhagic stroke including transient ischemic attack. E
  8. Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical treatment. E
  9. Ongoing cardiac dysrhythmia of grade ≥ 2, atrial fibrillation of any grade, QTc interval > 0.
  10. E
  11. Pregnant or breast feeding woman (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential). E
  12. Any acute or chronic medical or psychiatric condition or laboratory abnormality that would make the patient unsuited to study participation. E
  13. Any second malignancy within the last 3 years with the exception of basal cell carcinoma, in situ cervical cancer and pT1/a bladder cancer with no evidence of recurrent disease for 12 months. E
  14. Patients receiving strong inhibitor or inducer of CYP3A4 especially some anti-epileptic drugs. E
  15. Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements. E
  16. Participation to another clinical trial that might interfere with the evaluation of the main criterion. E
  17. Known hypersensitivity to the active substance or to any of the excipients of cabozantinib. E
  18. Patient requiring tutorship or curatorship.

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A Phase I Trial of Interleukin-2 (Aldesleukin) and Pembrolizumab Combination Therapy for Patients With Advanced Renal Cell Carcinoma


Condition: Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03260504

Sponsor: University of Washington

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Be willing and able to provide written informed consent for the trial
  • Have histologic confirmation of RCC with a clear cell component
  • Have advanced (not amenable to potentially curative surgery) or metastatic RCC
  • Available tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
  • May have received previous systemic treatments or regimens for metastatic RCC. Prior therapy can include checkpoint blocking antibodies targeting PD-1, PD-L1, or cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) and/or targeted agents including TKIs, mTOR inhibitors, or bevacizumab. Patients may choose to receive study treatment as their initial therapy
  • Previously treated patients must have documented disease progression after their last line of therapy
  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Absolute neutrophil count (ANC) >= 1,500 /mcL (within 14 days of treatment initiation)
  • Platelets >= 100,000/mcL (within 14 days of treatment initiation)
  • Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (within 14 days of treatment initiation)
  • Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) >= 40 mL/min for subject with creatinine levels > 1.5 X institutional ULN; creatinine clearance should be calculated by Cockcroft-Gault (within 14 days of treatment initiation)
  • Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (within 14 days of treatment initiation)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases (within 14 days of treatment initiation)
  • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 14 days of treatment initiation)
  • Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (within 14 days of treatment initiation)
  • Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >= 65% of predicted (dose level 2 and 3)
  • Left ventricular ejection fraction (LVEF) >= 50% measured by multigated acquisition (MUGA) scan, echo, or stress test study with myocardial perfusion imaging
  • Normal/negative cardiac stress testing with myocardial perfusion imaging OR cardiac catheterization with non-significant angiogram findings reviewed by a cardiology consultant (dose level 2 and 3)
  • Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
  • Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy

Exclusion Criteria:

  • Has received prior therapy with IL-2 or other investigational systemic cytokine therapy signaling through a common γ-chain cytokine receptor including IL-7, IL-15 or IL-21
  • Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
  • Has had a prior monoclonal antibody within 4 weeks prior to study day 1. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1
  • Adverse events due to prior treatment must be resolved to < grade 1 * Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • For patients previously treated with checkpoint blocking antibodies, no history of myocarditis, pneumonitis or nephritis of any grade associated with the prior treatment
  • Has had autoimmune toxicity associated with prior checkpoint blocking antibodies requiring more than one drug class of immune suppressive therapy to resolve (e.g. steroid-refractory toxicity requiring infliximab, mycophenolate mofetil, tacrolimus or other immune suppressive agent) or requiring continuous immune suppression > 12 weeks, or having a severity judged to be life threatening by the investigator
  • Has a known additional malignancy that is progressing or requires active treatment; exceptions include locally curable cancers such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • (Dose level 1) subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment
  • (Dose Level 2 and 3) subjects may not have any history of or current CNS metastases; baseline imaging of the brain is required within 28 days prior to the start of study treatments
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
  • Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study
  • Has history of (non-infectious) pneumonitis that required steroids or active, non-infectious pneumonitis
  • Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial fibrillation, or prolongation of the corrected QT interval defined as > 450 msec for males and > 470 msec for female
  • History of any of the following cardiovascular conditions within 6 months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, class III or IV congestive heart failure as defined by the New York Heart Association, symptomatic peripheral vascular disease, cerebrovascular accident, or transient ischemic attack
  • Has an active infection requiring systemic therapy
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
  • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment; Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

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Monitoring of Treatment Related Toxicities From Oral Targeted Agents and Immunotherapy Among Patients With Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study


Condition: Advanced Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03229083

Sponsor: University of Rochester

Eligibility:

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

Inclusion Criteria:

  • Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
  • Greater than 18 years of age
  • A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
  • Able to provide written informed consent
  • Proficient in the English language and self-reports as literate
  • Must have an active email address or access to a smart device on which text messages can be received

Exclusion Criteria:

  • Women cannot be breast-feeding
  • Does not have regular access to the internet
  • Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
  • Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change

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Phase II Clinical Study of PD-1 Monoclonal Antibody Combination With Autologous Cytokine-induced Killer Cell Immunotherapy in the Second-line Treatment of Metastatic Clear Cell Renal Cell Carcinoma


Condition: Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03987698

Sponsor: Tianjin Medical University Cancer Institute and Hospital

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

Inclusion Criteria:

  1. Subjects who must meet all the following criteria should be selected:
  2. Agreeing to participate in this study and signing a written informed consent.
  3. Male or female,from 18 to 75 years (including 18 and 75 years).
  4. The life expectancy will be longer than 3 months and can be followed up.
  5. Patients with metastatic clear cell renal cell carcinoma were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
  6. Patients with disease progression after treatment with interferon or TKI.
  7. ECOG score will be 0 or 1 within 7 days before randomization.
  8. Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria: White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range.
  9. The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).
  10. Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period.
  11. Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.

Exclusion Criteria:

  1. Subjects who meet any of the following criteria could not participate in this study:
  2. Other malignant tumors needed treatment within five years.
  3. Allogeneic tissue/organ transplantation.
  4. Participating in research drug therapy within 4 weeks before the first administration of the trial.
  5. Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy.
  6. Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug.
  7. Previous treatment with PD-1/PD-L1 antibodies.
  8. Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment.
  9. Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA > 10^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method.
  10. Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.
  11. Patients with active infections requiring systemic intravenous therapy.
  12. Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
  13. Subjects who are known to be allergic to any of the constituents of the drug being studied.
  14. Subjects with a recent history of drug abuse (including alcohol) within one year.
  15. Compliance is poor and can not cooperate with clinical research.
  16. Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.

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Pilot Study Using Parametric PET to Assess Early Treatment Response to Targeted Therapy for Renal Cell Carcinoma


Condition: Metastatic Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04020978

Sponsor: University of California, Davis

Eligibility:

  • Age: minimum 21 Years maximum 80 Years
  • Gender: All

Inclusion Criteria:

  • Patients with pathologically confirmed clear cell renal cell carcinoma who have primary RCC. For those patients whose primary kidney cancer is removed, they must have index metastatic cancer lesion(s) within the PET field of view for 18F-FDG parametric PET/CT analysis to determine response.
  • Patients are scheduled for targeted cancer therapy, including sunitinib, pazopanib, cabozantinib, everolimus, and others.
  • Ability to understand and willingness to sign an informed consent form.
  • Ability to adhere to the study visit schedule and other protocol requirements.
  • Men and women ≥21 years of age.
  • Life expectancy ≥ 6months.
  • Female subjects who are of non-reproductive potential (i.e., post-menopausal by history
  • no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Or, female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first drug administration.
  • Male and female subjects who agree to use highly effective method of birth control (e.g., implants, injectables, birth control pills with two hormones, intrauterine devices [IUDs], complete abstinence or sterilized partner, and female sterilization) and a barrier method (e.g., condoms, vaginal ring, sponge, etc.) during the period of therapy and for 90 days after the last dose of drug.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Any condition that would prohibit the understanding or rendering of informed consent.
  • Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that would prevent the subject from participating and adhering to study related procedures.
  • Prior treatment with any investigational drug within the previous 4 weeks
  • Unable to lie supine for 1-hour imaging with PET
  • Prisoners

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Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses


Condition: Renal Malignant Tumor, Renal Tumor

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04096534

Sponsor: Saint Petersburg State University, Russia

Eligibility:

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

Inclusion Criteria:

  • Suspected by computed tomography or another instrumental method renal mass
  • Clinical stage T1-2N0-2M0-1 (distant metastases must be resectable)
  • Indications for partial nephrectomy
  • Eastern Cooperative Oncology Group status 0-2
  • At least 18 years of age
  • Written informed consent

Exclusion Criteria:

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
  • Pregnancy or breast feeding
  • Medical contraindications for surgical treatment
  • Synchronous or metachronous malignancy
  • Non-resectable distant metastases
  • The patient's refusal to perform research procedures.
  • Refusal of the patient to continue participation in the study.

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Effect of Papaverine on Intraoperative Renal Artery Blood Flow Volume in Patients Undergoing Robot-assisted Partial Nephrectomy : a Randomized, Double-blind, Placebo-controlled Study


Condition: Kidney Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04162834

Sponsor: Asan Medical Center

Phase: Phase 4

Eligibility:

  • Age: minimum 20 Years maximum 79 Years
  • Gender: All

Inclusion Criteria:

  • Patients diagnosed with kidney cancer.
  • Patients undergoing robot assisted partial nephrectomy under general anesthesia
  • 20 years old ≤ age <80 years old
  • Patients who voluntarily agreed to this clinical study
  • eGFR ≥ 60 ml / min / 1.73 m2 (Chronic Kidney Disease Epidemiology Patients with Collaboration)

Exclusion Criteria:

  • The tumor ≥ 7 cm in size
  • Multiple renal mass
  • If the surgery plan is changed due to open
  • When surgery is performed together with other surgery
  • Multiple renal artery
  • Patients with hypersensitivity to papaverine
  • Patients with atrioventricular block
  • Pregnant and lactating women
  • Patients using levodopa
  • Refusal of patient

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Pilot Study of Cabozantinib Efficacy, Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients: CABOMAYOR Study


Condition: Old Age; Debility, Renal Carcinoma Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04134390

Sponsor: Spanish Oncology Genito-Urinary Group

Phase: Phase 2

Eligibility:

  • Age: minimum 70 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  1. Documented histological or cytological diagnosis of renal cell cancer.
  2. Measurable disease per RECIST 1.1 as determined by the investigator.
  3. Metastatic disease.
  4. Patient must have signed the informed consent document.
  5. Capable of understanding and complying with the protocol requirements.
  6. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-
  7. Patients aged >70 years old with Society of Geriatric Oncology (SIOG) defined fragile population or patients >75 years with or without SIOG defined fragility.
  8. No previous treatment for Metastatic Renal Cell Carcinoma (mRCC)
  9. Adequate organ function based on standard laboratory tests including haematology, serum chemistry, lipids, coagulation, thyroid function, and urinalysis.
  10. 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 course of the study and for 4 months after the last dose of study treatment.

Exclusion Criteria:

  1. Previous treatment for mRCC.
  2. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before inclusion.
  3. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 3 months before inclusion.
  4. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
  5. Chronic treatment with corticosteroids or other immunosuppressive agents
  6. Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders, Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation, Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 3 months before inclusion, Cavitating pulmonary lesion(s) or known endobronchial disease manifestation and/or Lesions invading major pulmonary blood vessels.
  7. Major surgery within 2 months before inclusion.
  8. Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 msec within 10 days before inclusion.
  9. Inability to swallow tablets or capsules.
  10. Previously identified allergy or hypersensitivity to components of the study treatment formulation.
  11. Diagnosis of another malignancy within 2 years before inclusion, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.

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Phase II Multicenter Open-Label Single-Arm Study of Decitabine Combined With Oxaliplatin in Patients With Relapsed/Metastatic Renal Cell Carcinoma


Condition: Metastatic Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04049344

Sponsor: Zhejiang Cancer Hospital

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: All

Inclusion Criteria:

  1. Age: 18 ~75 years old.
  2. Patients who are diagnosed pathologically with relapsed/metastatic renal cell carcinoma have a disease progression on standard of care.
  3. Performance status: Eastern Cooperative Oncology Group performance status ≦
  4. Life expectancy more than 3 months.
  5. Patients have adequate organ function, accord with following criteria: A. blood routine: Hemoglobin≥90g/L, absolute neutrophil count≥1.5×109/L, platelet count ≥ 80×109/L; B. Biochemical tests: total bilirubin is less than 1.5 times upper limit of normal, alanine aminotransferase and aspartate aminotransferase are less than 2.5 times upper limit of normal; C. creatinine less than 1.25 times upper limit of normal.
  6. Patients agree to use adequate contraception in the period of trial and need negative pregnancy test in childbearing potential women.
  7. Patients agree to receive treatment with epigenetic drugs.
  8. Participant sign an institutional review board—approved, protocol-specific informed consent form in accordance with institutional guidelines. Exclude criteria:
  9. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
  10. Organs failure.
  11. ECOG >
  12. Serious/active infection.
  13. Autoimmune disorders or immunodeficiency diseases.
  14. Patients with allergic constitution, or other disease need take drugs of immunosuppressant or corticosteroids.
  15. Uncontrolled hypertension.
  16. Myocardial ischemia (more than grade II ) or myocardial infarction or uncontrolled arrhythmia.
  17. Cardiac insufficiency of grade III to IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) <50%.
  18. Coagulation disorders, tendency of haemorrhage, undergoing thrombolytic or anticoagulant therapy.
  19. Unhealed wounds, or fractures.
  20. With a history of psychotropic drug abuse or mental disorders.
  21. Prior systemic therapies with any antitumor agents within 4 weeks.
  22. With other uncurable cancers simultaneously.

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Japanese Prospective Real World Registry of Nivolumab Plus Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (ARCC) Categorized Into IMDC Intermediate/Poor Risks (J-ENCORE)


Condition: Advanced or Metastatic Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04043975

Sponsor: Bristol-Myers Squibb

Phase:

Eligibility:

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

Inclusion Criteria:

  • Histological confirmation of Renal Cell Carcinoma (RCC)
  • No prior systemic therapy for RCC
  • RCC patients who are anticipated to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date
  • IMDC risk category Intermediate/Poor
  • ≧ 20 years old patients for whom informed consent was obtained from the patient at the time of this study participation

Exclusion Criteria:

  • Patients who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in Japan
  • Pregnant and/or lactating women
  • Patients who are judged to be inappropriate by investigator

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