Clinical Trial

A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)

Recruiting Phase 2
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Summary
This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab/ cemiplimab/ ipilimumab), Arm B (fianlimab/ cemiplimab), or Arm C (standard ipilimumab/ nivolumab), respectively.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-09-16; most recent amendment 2026-07-01.
Status change: Not Yet Recruiting → Recruiting 2026-02-20
Trial Details
NCT Number NCT07188896
Lead Sponsor Brian Rini
Collaborators: Regeneron Pharmaceuticals, Vanderbilt-Ingram Cancer Center
Conditions Advanced Renal Cell Carcinoma (aRCC), Metastatic Renal Cell Carcinoma ( mRCC), Clear Cell Renal Cell Carcinoma (ccRCC)
Enrollment 120 participants
Start Date 2026-04-29
Primary Completion 2029-11-30 (estimated)
Study Completion 2030-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06