Trials / Recruiting
RecruitingNCT07188896
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
A Randomized Phase 2 Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Brian Rini · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Advanced Renal Cell Carcinoma (aRCC)
- Metastatic Renal Cell Carcinoma ( mRCC)
- Clear Cell Renal Cell Carcinoma (ccRCC)
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2029-11-30
- Completion
- 2030-11-30
- First posted
- 2025-09-23
- Last updated
- 2026-04-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07188896. Inclusion in this directory is not an endorsement.