About this trial
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.
Eligibility criteria
Qualifiers
Biopsy proven clear cell renal cell carcinoma (ccRCC).
pT2 (by radiographic/size criteria), Grade 4 or with sarcomatoid/rhabdoid features (on biopsy), N0, M0
pT3 (presence of tumor thrombus, perinephric and/or sinus fat invastion by imaging), any grade, N0, M0 High-risk ccRCC*
pT4, any g.rade, N0, M0
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pembrolizumab
- Belzutifan
Treatment groups
Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator