CA224-098: Adjuvant Immunotherapy Combo vs Mono after Complete Resection of Stage III-IV Melanoma
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma
IRAS ID
1003930
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2021-001641-13
Clinicaltrials.gov Identifier
Research summary
This is a multicentre, phase 3 study of the investigational drug relatlimab in a fixed-dose combination (FDC) with nivolumab compared to nivolumab alone in patients ≥ 18 years with completely resected Stage III A/B/C/D or Stage IV no evidence of disease melanoma.
Relatlimab and nivolumab are types of immunotherapy drugs that are designed to stimulate the body’s own immune system to help attack cancer cells. This study will assess if relatlimab-nivolumab FDC delays cancer recurrence in melanoma. 1050 patients will take part globally in this study, 40 of them in the UK.
The study is double-blind, so patients and doctors will not know what treatment patients are on. Following a screening period, eligible patients will be randomly assigned to receive relatlimab-nivolumab FDC (160 mg/480 mg) or nivolumab (480mg) as an infusion through a vein every 4 weeks, during a hospital visit.
During the study, patients will have the following procedures: CT/MRI scans, ultrasounds, physical exams, ECG, vital signs (blood pressure, heart rate and temperature), blood sampling and pregnancy testing (if applicable). They will have to submit a tumour sample from their resection surgery and complete questionnaires regularly. They will have follow-up visits after they end treatment.
While on the study drug, visits will be every 4 weeks. Patients will receive study drug for max. 1 year (max. 13 doses), until they withdraw their consent, they no longer tolerate the study drug, or their cancer recurs. After study treatment is done, the 1st follow-up visit will be 30 days from the last dose and the 2nd visit will be 135 days from the last dose of study drug. Long-term follow up visits will be every 3 months afterwards (in clinic or by phone) for a min. of 6 years or until a participant meets end-of-study criteria.
In-person biomarker collections are required every 6 months during long-term follow up until end of study or first recurrence, whichever is first.REC name
East of England - Essex Research Ethics Committee
REC reference
21/EE/0238
Date of REC Opinion
16 Nov 2021
REC opinion
Further Information Favourable Opinion