Study of Nivolumab with or without Relatlimab for High-Risk Basal Cell Carcinoma
This study is looking at two different treatments for high-risk basal cell carcinoma (a type of skin cancer) that can be removed by surgery. You might be eligible if you are 18 or older and have a basal cell carcinoma that is 20 mm or larger on your head/neck, or 40 mm or larger on your body/limbs. The study compares Nivolumab alone to a combination of Relatlimab plus Nivolumab (Opdualag). Both treatments work by blocking signals that can stop your immune system from fighting cancer. Researchers will give you one of these treatments for about 4 cycles before surgery, and they will measure how much the cancer shrinks or disappears. The goal is to see which treatment leads to a better response in the cancer before surgery, and how well patients do over two years.
- Study design
- This is a Phase 2 study where participants are randomly assigned to receive either Nivolumab or Relatlimab plus Nivolumab (Opdualag). About 30 people are planned to join this study.
- What's involved
- Participants will receive 4 cycles of treatment every 4 weeks before surgery. There is an option to have surgery earlier or continue treatment longer, depending on how you respond.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for disease recurrence and other outcomes for at least 2 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
At a glance
Conditions
Where it's being run
3 sites across 1 statesStudy leadership
- Soo Park, MD · PRINCIPAL_INVESTIGATOR · UC San Diego Health - Moores Cancer Center
Who to contact
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What this trial measures
- Pathologic response rate2 years
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 rate2 years
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.