Phase 2 Study of Pucotenlimab and Vorolanib Before Surgery for High-risk Clear Cell Renal Cancer Evaluating Safety and Effectiveness in Kidney-Sparing Surgery Candidates

What this Trial Is About

Researchers are evaluating the combination of Pucotenlimab and Vorolanib as a neoadjuvant therapy for patients with localized clear cell renal cell carcinoma ccRCC who have high-risk tumors requiring partial nephrectomy but face challenges preserving kidney function. This phase II single-arm study aims to assess the safety and effectiveness of this treatment approach in enabling kidney-sparing surgery for tumors classified as T1b with a large endophytic component or T2 stage. Participants receive Vorolanib orally at 200 mg once daily, with or without food, and Pucotenlimab through intravenous infusion at 200 mg every three weeks. Treatment cycles last 21 days, with up to four cycles. Imaging evaluations, including renal CT scans and tumor volume measurements, are performed after two cycles to assess response. If disease progression is detected early, the study ends for that participant. Based on tumor shrinkage and surgical evaluation, participants may undergo partial nephrectomy or continue treatment up to four cycles before surgery. Throughout the study, participants undergo regular imaging and laboratory tests to monitor tumor response and organ function. The main outcome measured is the objective response rate after two or four treatment cycles, following RECIST 1.1 criteria. Participants must comply with scheduled visits, treatment plans, and assessments. The study ensures ongoing evaluation of safety and treatment effects over the treatment period, with total participation lasting through the neoadjuvant treatment and surgery phases.

Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC