Fianlimab & Cemiplimab compared with Pembrolizumab in resectable advanced stage Melanoma
Research type
Research Study
Full title
A Phase 2 and Phase 3 Peri-operative Trial of Fianlimab and Cemiplimab Compared with Anti-PD1 Alone in Patients with Resectable Stage III and IV Melanoma.
IRAS ID
1009590
Contact name
Muriel O'Byrne
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
The study is focused on participants with a type of skin cancer known as melanoma. Patients with melanoma will typically have surgery to remove the affected tumour area. The patients are also given pembrolizumab before and after surgery. However this study would like to see if the combination of fianlimab and cemiplimab is an effective treatment, compared to pembrolizumab. Fianlimab and cemiplimab are both considered experimental drugs.
Patients must meet specific criteria to participate in this study, which the study doctor will check. Eligible patients will be in the study for up to 5 years. This includes the
- screening period to determine if the patient is eligible to participate,
- treatment period when participants receive the study drug ( 1 year)
- follow up period once the treatment period is complete (4 years)During Part 1, participants will be randomly assigned to receive one of two treatment options; fianlimab with cemiplimab or cemiplimab with placebo (a dummy drug). There is a 50:50 chance of being allocated to either treatment option. Participants assigned to fianlimab and cemiplimab will receive a lower dose or a higher dose. Participants cannot decide which dose they receive. This is to help understand which dose of fianlimab and cemiplimab should be used for Part 2 of the study.
In part 2 of the study, participants will be assigned one of two treatment options fianlimab and cemiplimab or pembrolizumab. Participants in the finalimab and cemiplimab will receive a lower dose or a higher dose based on the information obtained in part 1 of the study.
During the study, participants will also be asked to provide blood and urine samples, an old sample of their tumour (or undergo a biopsy if the study doctor feels it is safe), and some scans (CT or MRI). The study team will also ask a series of questions called Quality of Life Assessments.
REC name
Wales REC 3
REC reference
24/WA/0314
Date of REC Opinion
18 Nov 2024
REC opinion
Further Information Favourable Opinion