Phase 3 Study Comparing Immune Checkpoint Inhibitor Combinations and VEGFR Tyrosine Kinase Inhibitors in First-Line Treatment of Metastatic Clear Cell Kidney Cancer

What this Trial Is About

Researchers are investigating treatments for metastatic clear cell renal cell carcinoma RCC, a type of kidney cancer. The study compares two combination therapies one using two immune checkpoint inhibitors ICI-ICI and the other combining an immune checkpoint inhibitor with a vascular endothelial growth factor receptor tyrosine kinase inhibitor ICI-VEGFR TKI. The goal is to determine which approach better improves overall survival and progression-free survival based on PD-L1 biomarker status, addressing the current lack of direct comparison between these treatments. Participants will receive one of two treatment plans. One group will get nivolumab and ipilimumab infusions every three weeks, followed by maintenance nivolumab for up to two years. The other group receives an investigators choice among three combinations axitinib plus pembrolizumab, cabozantinib plus nivolumab, or lenvatinib plus pembrolizumab. Oral and intravenous medications are administered at specified doses and schedules, with treatment continued until progression, unacceptable side effects, or two years of therapy. During the study, participants will undergo evaluations including survival tracking, tumor response assessments, and quality of life questionnaires at regular intervals. Researchers will also monitor treatment duration, adverse events, health economics, and collect biological samples for future research. The study plans to enroll 1,250 patients over four years across multiple European countries, with a total follow-up period extending up to 97 months to assess long-term outcomes.

CARE1 Pragmatic Clinical Trial