RecruitingPhase 2NCT06708949

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

15 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two immunotherapy combinations in people newly diagnosed with advanced kidney cancer (metastatic renal cell carcinoma): nivolumab + ipilimumab (the current standard dual immunotherapy) versus a three-drug combination that adds relatlimab (which blocks a different immune checkpoint called LAG-3) to see if the triple combination works better. **You may be eligible if...** - You are 18 or older - You have confirmed clear cell kidney cancer that has spread to other parts of the body (Stage IV) - You have not received any prior systemic therapy for this kidney cancer - You have at least one measurable tumor - You are in good functional condition (Karnofsky score ≥70%) - Your organ function is adequate **You may NOT be eligible if...** - You have already received systemic treatment for kidney cancer - You have received prior neoadjuvant or adjuvant immunotherapy - You have conditions making immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDrugs Nivolumab

Given by IV Infusion

DRUGIpilimumab

Given by IV Infusion

DRUGBMS-986213 (Relatlimab-Nivolumab FDC)

Given by IV Infusion


Locations(5)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06708949