Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
NCT06624475 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-02-05
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)
Conditions
Interventions
- DRUG
-
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).
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of California, San Diego
lead OTHER
Principal Investigators
-
Soo Park, MD · UC San Diego Health - Moores Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-21
- Primary Completion
- 2028-05-31
- Completion
- 2028-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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