Renal cell carcinoma (clear cell & non-clear cell), or kidney cancer MedDRA version: 20.1 Level: LLT Classification code 10023400 Term: Kidney cancer System Organ Class: 100000004864
Conditions
Interventions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Be willing and able to provide written informed consent for the trial - Be > or = 18 years of age on day of signing informed consent - Cohort A (clear cell cohort) must have histologically confirmed diagnosis of clear cell RCC or RCC with clear cell component (with or without sarcomatoid features) - Cohort B (non-clear cell cohort) must have histologically confirmed diagnosis of non-clear cell RCC (with or without sarcomatoid features) by the site pathologist. For Cohort B, sites will submit tissues for histologic confirmation of the diagnosis of non-clear cell RCC by central histology review during the screening phase. Sites should enroll subjects in Cohort B after receiving notice that the submitted tissue was adequate for central review. Confirmation of non-clear cell RCC histology by the central laboratory will be made available to the sites as a later date. - Have locally advanced/metastatic disease, i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer (AJCC) or have recurrent disease - Have measurable disease per RECIST 1.1 as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions - Have received no prior systemic therapy for advanced RCC. Note: Prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed > 12 months prior to allocation. - Provide adequate tissue for biomarker analysis for cohorts A and B - Demonstrate adequate organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 135
Exclusion criteria
Exclusion criteria: - Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to allocation, has had major surgery within 4 weeks or radiation therapy within 2 weeks prior to allocation, or who has not recovered (i.e., < or = Grade 1 or at baseline) from adverse events due to prior treatment - Had prior treatment with any anti-PD-1, or PD-L1, or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD-L1, IL-2R, GITR - Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding 10 mg daily dose of prednisone or equivalent or any other form of immunosuppressive therapy within 7 days prior to allocation, except in the case of central nervous system (CNS) metastases - Has an active autoimmune disease requiring systemic treatment within the past 2 years, (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); OR a documented history of clinically severe autoimmune disease - Has a known additional malignancy that has had progression or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, such as breast cancer in situ, that has undergone potentially curative therapy are acceptable - Has known CNS metastases and/or carcinomatous meningitis - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis - Has had a prior solid organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To estimate the ORR per RECIST 1.1 as assessed by BICR in subjects with clear cell RCC. 2. To estimate the ORR per RECIST 1.1 as assessed by BICR in subjects with non-clear cell RCC.;Secondary Objective: 1. To estimate the duration of response (DOR), disease control rate (DCR), and the progression-free survival (PFS) per RECIST 1.1 as assessed by BICR and overall survival (OS) in subjects with clear cell or non-clear cell RCC by cohort. 2. To determine the safety and tolerability of pembrolizumab in subjects with clear cell or non-clear cell RCC by cohort. 3. To describe the patient population using the International Metastatic RCC Database Consortium (IMDC) risk group : favorable versus intermediate versus poor risk groups in subjects with clear cell or non-clear cell RCC by cohort [1,2,3]. ;Primary end point(s): Objective response rate (ORR) per RECIST 1.1 by BCIR;Timepoint(s) of evaluation of this end point: At Interim & Final Analyses. Interim Analysis to be conducted on the non clear cell RCC cohort and is to be performed at the time when the 30th subject in this cohort has the opportunity to complete the 3rd scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Duration of response (DOR) per RECIST 1.1 by BCIR - Disease control rate (DCR) per RECIST 1.1 by BCIR - Progression-free survival (PFS) per RECIST 1.1 by BCIR - Overall survival (OS);Timepoint(s) of evaluation of this end point: At Interim & Final Analyses | — |
Countries
Canada, Czechia, Czech Republic, Denmark, Germany, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trial Operation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed