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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 (Jun 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 Jun 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

Treatments studied

Immunotherapy

Drugs NivolumabIpilimumabBMS-986213 (Relatlimab-Nivolumab FDC)

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 →

Frequently asked questions

Is NCT06708949 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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