A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in Fir… (NCT07188896) | Clinical Trial Compass
RecruitingPhase 2
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
United States120 participantsStarted 2026-04-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV \[version 9\]) renal cell carcinoma.
✓. Treatment naïve for systemic therapy for renal cell carcinoma including no prior neo/adjuvant systemic therapy
✓. Measurable disease according to RECIST 1.1 within 28 days prior to registration.
✓. Patient must have either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, obtained from preferably a metastatic lesion, preferably within 3 months or no more than 12 months with an associated pathology report. If the metastatic lesion biopsy specimen does not contain at least 20 unstained slides, supplementation with primary kidney cancer tissue is acceptable.
Exclusion criteria
✕. Prior systemic therapy against renal cell carcinoma in the neo/adjuvant or metastatic setting
✕. Any condition requiring ongoing ≥ 10 mg prednisone equivalent/day
✕. 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.
✕. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are allowed: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
✕. Central nervous system (CNS) metastases as described in the protocol.
✕. Active infection requiring systemic therapy as described in the protocol.
✕. Pregnant or breastfeeding as described in the protocol.