Phase II Trial Comparing IBR854 Plus Pazopanib to Pazopanib Alone for Advanced Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating treatments for Advanced Renal Cell Carcinoma RCC in this multicenter, randomized, open-label Phase II clinical study. The study compares the combination of IBR854 with Pazopanib against Pazopanib alone, aiming to assess their efficacy and safety. Participants with advanced clear cell RCC who meet specific health criteria will be enrolled to better understand treatment outcomes. Participants will be assigned randomly in a 21 ratio to either receive IBR854 combined with Pazopanib or Pazopanib alone. IBR854 is given by intravenous infusion on day 1 and day 8 of each 21-day cycle at a fixed dose, while Pazopanib is taken orally daily without food at a fixed dose of 800mg. Treatment continues until criteria for stopping are met, with ongoing data collection on effectiveness and safety. During the study, participants will undergo regular assessments including tumor measurements per RECIST 1.1 criteria, laboratory tests to monitor organ function, and evaluations of adverse events. The main outcome measured is progression-free survival over about two years, along with secondary outcomes like overall survival, response rates, and duration of response. Participants are followed closely to monitor health and treatment effects throughout the trial.

A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma