Search Results
PSCI 26-001: A Randomized Phase 2 Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
The purpose of this voluntary research study is to find out if cemiplimab and fianlimab with or without ipilimumab can shrink or stop advanced or metastatic clear cell kidney cancer from growing. This research study will include a screening period, a treatment period, and a follow up period, and participation may last up to five years
Participant will need to complete several screening tests. If participant qualifies for the study, participant will be asked to receive one of the study treatment combinations. Cemiplimab, fianlimab, and ipilimumab, or Cemiplimab and fianlimab, or Ipilimumab and nivolumab. Participant will continue receiving assigned combination for up to 96 weeks (about 22 months). Have regular tests and assessments, which may include physical exams, blood tests, imaging scans, and other procedures needed for your safety and for study purposes.
Karnofsky Performance Status ≥ 70% within 14 days prior to registration.
Measurable disease according to RECIST 1.1 within 28 days prior to registration.
Platelets: ≥ 100,000 /mm3
Hemoglobin: ≥ 9 g/dL
Participants with a history of myocarditis.
Any condition requiring ongoing ≥ 10 mg prednisone equivalent/day
Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents.
Central nervous system (CNS) metastases.