Phase 2 Study of Adding Stereotactic Radiation Therapy to Immunotherapy for Treating Adults with Metastatic or Unresectable Renal Cell Cancer

What this Trial Is About

Researchers are evaluating whether adding stereotactic ablative radiotherapy SABR to standard immunotherapy improves outcomes in patients with metastatic or unresectable renal cell carcinoma that cannot be surgically removed. This phase II trial compares SABR combined with immunotherapy against immunotherapy alone. The study focuses on nephrectomy and radiographic progression-free survival as primary measures and also assesses safety, response rates, overall survival, and other outcomes over up to 8 years. Participants are randomly assigned to one of two treatment groups. One group receives standard immunotherapy regimens, including combinations of drugs such as nivolumab, ipilimumab, pembrolizumab, avelumab, axitinib, cabozantinib, or lenvatinib administered intravenously or orally at specified intervals. The other group receives SABR on three days over 1 to 3 weeks plus the same immunotherapy options. Imaging scans such as CT or MRI, and sometimes bone scans and blood collections, are done throughout the trial. Participants undergo regular assessments including imaging and blood tests to monitor the cancers response and safety of treatments. After treatment completion, follow-up visits occur every 6 months for 5 years, then annually for 3 more years, totaling up to 8 years of monitoring. Researchers measure outcomes such as progression-free survival, response rates, nephrectomy rates, and adverse events during this time to evaluate the treatments.

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial