Phase 3 Study Comparing Casdatifan Plus Cabozantinib to Placebo Plus Cabozantinib in Adults With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating the progression-free survival of casdatifan compared to placebo when each is given alongside cabozantinib in adults with confirmed advanced or metastatic clear cell Renal Cell Carcinoma. This study focuses on patients who have experienced disease progression after prior anti-PD-1 or anti-PD-L1 immunotherapy. The trial is a randomized, double-blind, phase 3 study designed to assess treatment outcomes in this patient population. Participants receive either casdatifan combined with cabozantinib or placebo combined with cabozantinib, both taken orally. The study is conducted in parallel groups with participants randomly assigned to one of these two arms. Treatment and monitoring continue for up to about 33 months to evaluate progression-free survival and other outcomes. During the study, participants will undergo assessments including imaging scans to measure tumors according to RECIST 1.1 criteria, laboratory tests to evaluate organ function, and symptom questionnaires related to kidney cancer. Researchers will monitor treatment-emergent side effects and measure overall survival, response rates, and symptom changes. The total study duration may extend up to approximately 64 months for long-term outcome follow-up.

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma