CompletedCancerNIHR-supported projectDigestion, Kidneys & Other Organs
A Phase 3 Trial of Fianlimab (anti-LAG-3) and Cemiplimab versus Pembrolizumab in the Adjuvant Setting in Patients with Completely Resected High-risk Melanoma
Recipient organisationNIHR University College London Hospitals Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodMar 2025 — Jun 2025
In plain English
AI plain-English summary
Around 1,530 people with high-risk melanoma will receive either an experimental two-drug combination or an approved single drug after their tumours have been surgically removed, to see which better prevents the cancer from coming back. This matters because even after successful surgery, about 40% of melanoma patients see their disease return, and for 25% it spreads to other parts of the body. Current options to reduce that risk are limited. The trial compares a new combination—fianlimab plus cemiplimab—against the established drug pembrolizumab, both of which work by unleashing the immune system against cancer cells. If the experimental combination proves more effective, it could become a new standard treatment for the roughly 1 in 4 melanoma patients whose disease is caught at a high-risk stage. That would mean fewer people needing further rounds of treatment for recurrent cancer, and longer periods without the disease returning or spreading. For patients and clinicians, that translates into a clearer, more effective option for the critical window right after surgery, when the goal is to stop the cancer before it gets a second chance.
View original technical description
This study will look at how effective an experimental combination of study drugs (fianlimab & cemiplimab) is compared to an approved drug called pembrolizumab in people who have had skin cancer (cutaneous melanoma) surgically removed but remain at high risk of the skin cancer returning. Cutaneous melanoma is one of the most aggressive forms of skin cancer & the amount of people to suffer from the disease has continued to rise over the past 40 years. It accounts for the majority of skin cancer-related deaths.Most patients with newly diagnosed skin cancer are able to have it surgically removed & are potentially cured,however,the 5-year survival rate of these patients following surgery depends on the stage of disease at diagnosis.Despite recent advances in treatment,in approx 40% of patients the disease returns & for 25% it returns to other parts of the body following surgery which intends to cure the disease. Thus,more options are needed for the treatment of resectable melanoma to improve patients survival rates without the disease recurring,also known as relapse free survival or RFS.In view of the significant risk of disease recurrence,there is a strong clinical rationale for further treatment following the surgery with the aim of improving RFS & distant metastasis-free survival for patients with high-risk disease.Therefore,identifying additional effective treatment regimens for patients following surgery is of key importance for prolonging survival in people with skin cancer.This study will include about 1530 participants across 200 sites worldwide. NHS sites will undertake the study in the UK. Participants must be 12 years + with Stage IIC,III,or IV skin cancer & who have had surgery to completely remove their cancer.Patient participation will last up to 5 years & will involve: - Intravenous infusions- CT &/or MRI scans- Brain scans- Questionnaires- Physical examinations- Electrocardiograms- Blood tests- Urine test- Tumour biopsy
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