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

NCT06624475 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CA209-1451810617
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Pathologic response rate

  The primary endpoint of this study is to evaluate the pathologic response rate (pathological complete response \[pCR\] plus major pathological response \[MPR\])) and the clinical complete response rate of Opdualag and Nivolumab in patients with resectable High-Risk Basal Cell Carcinoma.

  2 years

• Clinical complete response rate

  Clinical complete response rate, per World Health Organization (WHO) Clinical Response Criteria for externally visible tumor(s) which can only be assessed clinically with bidimensional measurements.

  2 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

Nivolumab 480 mg intravenous and Relatlimab 160 mg intravenous every 4 weeks, up to 4 cycles.

Drug: Relatlimab plus Nivolumab

Cohort 2

EXPERIMENTAL

Nivolumab 480 mg intravenous every 4 weeks, up to 4 cycles.

Drug: Nivolumab

Interventions

Nivolumab 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).

Also known as: Opdivo

Cohort 2

Relatlimab plus Nivolumab DRUG

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).

Also known as: Opdualag

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document.
• Participants must have histologically or cytologically confirmed basal cell carcinoma.
• Participants must have high risk BCC as defined by size 20 mm or greater in the head and neck region or 40 mm or greater for the trunk/extremities.
• Participants must have surgically resectable BCC that is at increased risk for cosmetic disfigurement, functional defects, poor oncologic control, or anticipated to require skin grafting or free flap reconstruction per investigator assessment.
• Participants must have treatment naive BCC.
• Aged 18 years or older.
• Eastern Cooperative Oncology Group Performance Status 0 or 1
• Demonstrates adequate organ function as defined below:
• Adequate bone marrow function
• Absolute neutrophil count ≥ 1,500/microliter
• Platelets ≥ 100,000/microliter
• Adequate hepatic function
• Total bilirubin \>1.5 x institutional upper limit of normal (except participants with Glibert Syndrome who must have a total bilirubin level of \<3.0xULN)
• Aspartate aminotransferase (AST or SGOT) ≤ 3 x institutional upper limit of normal
• Alanine transaminase (ALT or SGPT) ≤ 3 x institutional upper limit of normal

You may not qualify if:

• Is currently receiving any other investigational agents.
• Has participated in a study of an investigational product and received study treatment or used an investigational device within 4 weeks of the first dose of study treatment.
• Hypersensitivity to Opdualag, nivolumab, or any of their excipients.
• Presence of untreated (symptomatic) central nervous system metastases.
• Presence of leptomeningeal metastatic disease.
• Treatment with any live / attenuated vaccine within 30 days of first study treatment.
• Radiation therapy within 2 weeks prior to first study treatment. Participants must have recovered (i.e., Grade ≤1 or at baseline) from radiation related toxicities prior to first study treatment.
• Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Note: Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Participants with an active, known, or suspected autoimmune disease. Note: Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Prior allogeneic tissue/solid organ transplant.
• Severe uncontrolled cardiac disease within 6 months of screening, including but not limited to poorly controlled hypertension , unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, or clinically significant uncontrolled cardiac arrhythmias.
• Any prior history of myocarditis and/or current diagnosis of myocarditis, regardless of etiology.
• Troponin T (TnT) or I (TnI) \> 2 x institutional upper limit of normal (ULN).
• Participants with TnT or TnI levels between \> 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. I f TnT or TnI levels are between \> 1× to 2× ULN within 24 hours, the participant must be evaluated by a cardiologist. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \< 2× ULN, the participant must be evaluated by a cardiologist.
• After cardiologist evaluation, the participant may be considered for randomization if the Investigator assesses a favorable benefit/risk.

Sponsors & Collaborators

• University of California, San Diego: lead
• Bristol-Myers Squibb: collaborator

Study Sites (3)

University of California, Irvine

Irvine, California, 92868, United States

RECRUITING

University of California, San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Nivolumab; relatlimab; Opdualag

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Soo Park, MD

  UC San Diego Health - Moores Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine O'Neil, BS

CONTACT

858-822-5354; CancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist, Associate Professor of Medicine

Model Details: 2:1 randomization

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: October 3, 2024
• Study Start: August 21, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)