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)
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.
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.
Parallel
Nivolumab
DrugNivolumab 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).
Relatlimab plus Nivolumab
DrugRelatlimab 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).
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.
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.
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University of California, San Diego
Lead sponsor
Bristol-Myers Squibb
Collaborator
