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

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.

Trial Details

NCT ID
NCT07188896
Phase
PHASE2
Sponsor
Brian Rini
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Fianlimab
  • Ipilimumab
  • Nivolumab
  • Cemiplimab
Locations (sample)
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Milwaukee, Wisconsin, United States|43.0389,-87.90647

Key Eligibility Criteria

  • Signed informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be …
  • Age ≥ 18 years at the time of consent.
  • Karnofsky Performance Status ≥ 70% within 14 days prior to registration.
  • Histological or cytological evidence of renal cell carcinoma having a clear cell component

For full eligibility, visit ClinicalTrials.gov.

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