A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
- Trial number:
- NCT05239728
- Trial phase:
- 3
- Study type:
- Immunotherapy, Targeted therapy, Chemotherapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
The main inclusion and exclusion criteria include but are not limited to the following:
Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0 M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous) Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization. Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last Has adequate organ function