NCT06624475

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Patients will be treated with 4 cycles of neoadjuvant Nivolumab + Relatlimab (Opdualag, cohort 1) or Nivolumab (cohort 2) given every 4 weeks followed by surgical resection. There will be an option to proceed directly to surgery after 2 cycles of therapy should patients have frank progression of disease based on clinical evaluation. There will also be an option to continue with Opdualag or Nivolumab beyond 4 cycles if there is ongoing clinical benefit per investigator discretion. If there is clinical evidence of a clinical complete response, patients may forgo surgery per investigator discretion. The primary outcome of pathologic response rate will be assessed at the time of resection. Patients will then be monitored for disease recurrence and other secondary outcomes.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	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).
DRUG	Relatlimab 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).

Timeline

• Start date: 2025-08-21
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2024-10-03
• Last updated: 2026-02-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study