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OncoMatch/Clinical Trials/NCT06708949

A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

Is NCT06708949 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Drugs Nivolumab and Ipilimumab for renal cell carcinoma, clear cell.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT06708949Data as of May 2026

Treatment: Drugs Nivolumab · Ipilimumab · BMS-986213 (Relatlimab-Nivolumab FDC)This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.

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Extracted eligibility criteria

Cancer type

Renal Cell Carcinoma

Disease stage

Required: Stage IV

Metastatic disease required

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Lab requirements

Blood counts

WBC ≥ 2,000 /µL; ANC ≥ 1,500/µL; Platelets ≥ 100,000/µL

Kidney function

Serum creatinine < 1.5 x ULN or creatinine clearance > 30 mL/min (Cockroft-Gault)

Liver function

Total bilirubin ≤ 1.5 x ULN (except Gilbert Syndrome < 3.0 mg/dL); ALT and AST ≤ 3 x ULN

Cardiac function

Troponin T (TnT) or I (TnI) ≤ 2× ULN (see protocol for repeat testing and exceptions)

Adequate organ function within 28 days prior to first dose... WBC ≥ 2,000 /µL; ANC ≥ 1,500/µL; Platelets ≥ 100,000/µL; Serum creatinine < 1.5 x ULN or creatinine clearance > 30 mL/min; Total bilirubin ≤ 1.5 x ULN (except Gilbert Syndrome < 3.0 mg/dL); ALT and AST ≤ 3 x ULN; Troponin T (TnT) or I (TnI) ≤ 2× ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Beth Israel Deaconess Medical Center · Boston, Massachusetts
  • Duke University Medical Center · Durham, North Carolina
  • Vanderbilt University Medical Center · Nashville, Tennessee
  • University of Texas Southwestern Medical Center · Dallas, Texas
  • The University of Texas M. D. Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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