A Randomized Phase 2 Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
Brian Rini
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. Karnofsky Performance Status ≥ 70% within 14 days prior to registration. 4. Histological or cytological evidence of renal cell carcinoma having a clear cell component 5. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV \[version 9\]) renal cell carcinoma. 6. Treatment naïve for sys…
Interventions
- DrugFianlimab
Fianlimab will be co-administered by IV.
- DrugIpilimumab
Ipilimumab will be administered by IV.
- DrugNivolumab
Nivolumab will be administered by IV. Maintenance nivolumab will then be administered by IV.
- DrugCemiplimab
Cemiplimab will co-administered by IV.
Location
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee