RecruitingPhase 2NCT06624475

Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma

Randomized Phase II Trial Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma


Sponsor

University of California, San Diego

Enrollment

30 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2 clinical trial with a 2:1 randomization comparing neoadjuvant Nivolumab + Relatlimab (Opdualag) vs neoadjuvant Nivolumab in patients with resectable high risk basal cell carcinoma (HR BCC)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a second immunotherapy drug (relatlimab) to nivolumab (a standard immunotherapy drug) before surgery helps reduce tumors more in people with high-risk basal cell carcinoma (BCC) — a type of skin cancer — that can be surgically removed. The goal is to see if the combination shrinks tumors more effectively before surgery than nivolumab alone. **You may be eligible if...** - You are 18 or older - You have been diagnosed with basal cell carcinoma confirmed by biopsy - Your BCC is "high-risk" (at least 20 mm on the head/neck, or at least 40 mm elsewhere) - Your cancer can be surgically removed, but surgery is expected to cause significant cosmetic or functional problems - You have not previously treated this BCC - Your physical health is reasonable (ECOG 0–1) **You may NOT be eligible if...** - You have already received treatment for this BCC - Your BCC cannot be removed with surgery - You have active autoimmune conditions or are on immunosuppressive medications - You are pregnant or breastfeeding 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

DRUGNivolumab

Nivolumab is a fully humanized monoclonal antibody that binds to the Programmed Death-1 (PD-1) receptor, blocking its interactions with Programmed Death-Ligand 1 (PD-L1) and Programmed Death-Ligand 2 (PD-L2), and thus additionally inhibiting PD1-driven immune suppression. Nivolumab: 480 mg via intravenous administration (28 day cycle).

DRUGRelatlimab plus Nivolumab

Relatlimab plus Nivolumab (Opdualag) is supplied as a single dose vial containing 480 mg of Nivolumab and 160 mg Relatlimab for intravenous administration (28 day cycle).


Locations(3)

University of California, Irvine

Irvine, California, United States

University of California, San Diego Moores Cancer Center

La Jolla, California, United States

University of California, San Francisco

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

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NCT06624475


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