To learn if belzutifan alone, pembrolizumab alone, or belzutifan and pembrolizumab in combination given before a total or partial nephrectomy (surgery to remove all or part of a kidney) can help to control locally advanced ccRCC.
Biopsy or archival tissue proven clear cell renal cell carcinoma (ccRCC).
T2 (by radiographic/size criteria), Grade 4 or with sarcomatoid/rhabdoid features (on biopsy), N0, M0
T3 (presence of tumor thrombus, perinephric and/or sinus fat invastion by imaging), any grade, N0, M0 High-risk ccRCC*
T4, (by radiographic criteria), any grade, N0, M0
A pulse oximeter reading <92% at rest, or
Requires intermittent supplemental oxygen, or
Requires chronic supplemental oxygen
Diagnosis of immunodeficiency, active autoimmune disease (per Investigator's discretion), history of pneumonitis, active infection, or known additional malignancy other than RCC.
Single group
Pembrolizumab
DrugOral administration
Belzutifan
DrugOral administration
1. Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
