Actively Recruiting
Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
Led by University of California, San Diego · Updated on 2026-02-05
30
Participants Needed
3
Research Sites
140 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Histologically or cytologically confirmed basal cell carcinoma
- High risk BCC defined as tumor size 20 mm or greater in head/neck or 40 mm or greater on trunk/extremities
- Surgically resectable BCC with increased risk for cosmetic or functional issues or need for grafting/reconstruction
- Treatment-naive basal cell carcinoma
- Age 18 years or older
- Eastern Cooperative Oncology Group Performance Status 0 or 1
- Adequate bone marrow, liver, and kidney function as defined by specific laboratory values
- HIV-positive patients on effective therapy with undetectable viral load and no recent opportunistic infections, CD4 count ≥ 350 cells/microliter
- Controlled chronic hepatitis B with undetectable viral load if on therapy
- Treated and cured hepatitis C or undetectable viral load if on treatment
- No active malignancy requiring treatment; prior malignancies must be in remission for at least 2 years
- Women of childbearing potential must use highly effective contraception during and 5 months after treatment, with no egg donation during this time
- Women not of childbearing potential must provide documentation or negative pregnancy test before treatment
You will not qualify if you...
- Receiving other investigational agents currently
- Received investigational treatment or device within 4 weeks before study treatment
- Allergic or hypersensitive to Opdualag, nivolumab, or their components
- Untreated symptomatic brain metastases or leptomeningeal disease
- Vaccinated with live or attenuated vaccine within 30 days before treatment
- Radiation therapy within 2 weeks before treatment without full recovery
- Need for systemic corticosteroids (>10 mg prednisone daily) or other immunosuppressants recently
- Active autoimmune disease requiring systemic treatment (except some stable conditions)
- History of allogeneic tissue or organ transplant
- Severe uncontrolled heart disease within 6 months
- History or current myocarditis
- Elevated troponin levels above institutional limits unless cleared by cardiologist
- Other severe medical or psychiatric conditions that increase risk or interfere with study
- Pregnant or breastfeeding women due to potential risks from study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of California, Irvine
Irvine, California, United States, 92868
Actively Recruiting
2
University of California, San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
C
Catherine O'Neil, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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