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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2029

Study Completion Date

November 30, 2030

Conditions
Advanced Renal Cell Carcinoma (aRCC)Metastatic Renal Cell Carcinoma ( mRCC)Clear Cell Renal Cell Carcinoma (ccRCC)
Interventions
DRUG

Fianlimab

Fianlimab will be co-administered by IV.

DRUG

Ipilimumab

Ipilimumab will be administered by IV.

DRUG

Nivolumab

Nivolumab will be administered by IV. Maintenance nivolumab will then be administered by IV.

DRUG

Cemiplimab

Cemiplimab will co-administered by IV.

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

collaborator

Vanderbilt-Ingram Cancer Center

OTHER

lead

Brian Rini

OTHER

NCT07188896 - A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC) | Biotech Hunter | Biotech Hunter