Immune and Targeted Combination Therapies for Kidney Cancer
Trial Summary
What is the purpose of this trial?
Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.
Eligibility Criteria
This trial is for adults with advanced first line clear cell renal cell carcinoma who haven't had systemic therapy for it. They must be able to take oral meds, have good organ function, and manage contraception if needed. Excluded are those with recent vaccines, multiple cancer treatments, immunodeficiency or other cancers within 3 years.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Belzutifan (Other)
- Favezelimab (Other)
- Lenvatinib (Other)
- Pembrolizumab (Checkpoint Inhibitor)
- Quavonlimab (Other)
- Vibostolimab (Other)
Belzutifan is already approved in United States for the following indications:
- Advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI
- Von Hippel-Lindau disease-associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors