drugset / Trial / NCT07188896
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
Phase 2
Recruiting
120 enrolled
Brian Rini
Regeneron Pharmaceuticals · collabVanderbilt-Ingram Cancer Center · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-04-29
- Primary completion
- 2029-11-30
- Completion
- 2030-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cemiplimab | Monoclonal antibody | — | Intravenous |
| Subject | Fianlimab | Monoclonal antibody | — | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | — | Intravenous |
| Comparator | Nivolumab | Monoclonal antibody | — | Intravenous |