M.D. Anderson Cancer Center
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.
Primary Objective: 1\. A composite primary endpoint of objective response rate (ORR) or pathologic response rate (PRR) at 12 weeks after neoadjuvant therapy. objective response - defined as partial \[≥ 30% decrease in largest diameter\] or complete response on imaging at 12 weeks after neoadjuvant therapy (according to Response Evaluation Criteria In Solid Tumors \[RECIST\] criteria) (Appendix 14.2) Pathologic response - defined as ≤25% residual viable tumor in post-therapy pathology specimen. Secondary Objectives: 1. Relapse-Free Survival (RFS) - defined as the length of time after random…
Inclusion Criteria: Patient must meet the following criteria to be eligible for participation in the trial: * Biopsy or archival tissue proven clear cell renal cell carcinoma (ccRCC). a. Extra tissue should be submitted if available for correlative analysis. Formalin-fixed paraffinembedded (FFPE) tissue blocks are preferred to slides. Details pertaining to tumor tissue submission can be found in the Lab Procedures Manual. * Has intermediate-high risk, high risk, or M1 ccRCC as defined by the following pathological tumor-node metastasis and tumor grading: Intermediate-high risk ccRCC\* 1…
Oral administration
Oral administration
Arctuva estimate
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