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.
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.
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
Prior systemic therapy against renal cell carcinoma in the neo/adjuvant or metastatic setting
Any condition requiring ongoing ≥ 10 mg prednisone equivalent/day
Participants with a history of myocarditis.
If clinically indicated based on clinical assessment and any ECG abnormalities, optional troponin T (TnT) or troponin I (TnI) may be done as described in the protocol.
Brian Rini
Lead sponsor
Hoosier Cancer Research Network
Sponsor institution
Regeneron Pharmaceuticals
Collaborator
Vanderbilt-Ingram Cancer Center
Collaborator