Phase 12 Study of Pumitamig Alone or Combined With Ipilimumab or Cabozantinib in Adults With Advanced Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of the drug Pumitamig alone or combined with Ipilimumab or Cabozantinib in adults with advanced Renal Cell Carcinoma RCC. This study focuses on participants with locally advanced, unresectable, or metastatic RCC, including both clear cell and non-clear cell types in the initial phase, and only clear cell RCC in later phases. The trial is conducted in phases 1 and 2 to gather detailed information about these treatments. Participants receive specified doses of Pumitamig, Ipilimumab, and Cabozantinib according to study group assignments. The study uses a randomized, parallel design with multiple experimental arms to compare these treatments alone or in combination. Participants may be assigned to one of several groups receiving different drug combinations, with dosing schedules specified by the protocol. During the study, participants undergo regular safety monitoring for adverse events and serious adverse events for up to approximately two years after treatment ends. Effectiveness is assessed by measuring tumor response using established criteria and tracking progression-free survival and duration of response over time. The study includes ongoing evaluations and follow-up visits to observe treatment impact and monitor participant health until the studys completion in 2031.

A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)