Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
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)
detailed 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 discretion. The primary outcome of pathologic response rate will be assessed at the time of resection. Patients will then be monitored for disease recurrence and other secondary outcomes.
official title
Randomized Phase II Trial Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma