Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)
M.D. Anderson Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Biopsy 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. pT2 (by radiographic/size criteria), Grade 4 or with sarcomatoid/rhabdoid features (on biopsy), N0, M0 2.…
Interventions
- DrugPembrolizumab
Oral administration
- DrugBelzutifan
Oral administration
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas