Randomized Phase II Trial Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
University of California, San Diego
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)
Description
Patients will be treated with 4 cycles of neoadjuvant Nivolumab + Relatlimab (Opdualag, cohort 1) or Nivolumab (cohort 2) given every 4 weeks followed by surgical resection. There will be an option to proceed directly to surgery after 2 cycles of therapy should patients have frank progression of disease based on clinical evaluation. There will also be an option to continue with Opdualag or Nivolumab beyond 4 cycles if there is ongoing clinical benefit per investigator discretion. If there is clinical evidence of a clinical complete response, patients may forgo surgery per investigator discreti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent document. 2. Participants must have histologically or cytologically confirmed basal cell carcinoma. 3. 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. 4. 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. 5…
Interventions
- DrugNivolumab
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).
- DrugRelatlimab 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).
Locations (3)
- University of California, IrvineIrvine, California
- University of California, San Diego Moores Cancer CenterLa Jolla, California
- University of California, San FranciscoSan Francisco, California