Evaluating Primary Tumor Treatments in Metastatic Renal Cell Carcinoma with Immunotherapy Combinations A Phase IV Randomized Study

What this Trial Is About

Researchers are evaluating treatment options for patients with metastatic renal cell carcinoma mRCC who have shown initial benefit from anti-PD1-based immunotherapy. This Phase IV, randomized, multi-arm, multicenter clinical trial aims to determine whether treating the primary kidney tumor can improve overall survival. The study focuses on patients with clear cell histology renal cancer who continue to receive standard immune-based medical therapies without disease progression. Participants with primary kidney tumors 4 cm or smaller will be randomly assigned to one of three groups cytoreductive nephrectomy plus standard care, radiotherapy on the primary tumor plus standard care, or standard care alone. Those with tumors larger than 4 cm will be randomized to either deferred cytoreductive nephrectomy plus standard care or standard care alone. Radiotherapy involves a single 25 Gy dose or equivalent fractions, and nephrectomy options include radical, partial, or lumpectomy. Medical therapy continues alongside these interventions using combinations such as axitinib plus pembrolizumab or nivolumab-based regimens. During the study, participants will undergo regular assessments including survival monitoring over 30 months. Researchers will evaluate overall and progression-free survival, adverse events, quality of life through EQ-5D-5L and FKSI-19 questionnaires, and surgery-related complications. Follow-up includes monitoring laboratory function and imaging to assess tumor response and safety. The entire participation period spans at least 30 months to assess the long-term effects of these treatment strategies.

Primary Tumor Ablation and Outcome in Metastatic Renal Cell Carcinoma Treated With Immunotherapy Combinations.