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.
University of California, San Diego
Lead sponsor
Bristol-Myers Squibb
Collaborator