CA224-047 Nivolumab and Relatlimab in melanoma
Research type
Research Study
Full title
A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma
IRAS ID
240940
Contact name
Ashita Waterston
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-003583-12
Duration of Study in the UK
1 years, 8 months, 7 days
Research summary
This is a multicentre, phase 3 study of the investigational drug BMS-986213 (a fixed dose combination of Nivolumab and another investigational drug called relatlimab) or Nivolumab alone in patients, who are at least 12 years old, with previously untreated metastatic, or unresectable melanoma.
Both Nivolumab and relatlimab are types of immunotherapy drug that are designed to stimulate the body’s own immune system to help attack cancer cells.
This study will assess if BMS-986213 delays the progression of previously untreated metastatic, or unresectable melanoma for longer than Nivolumab alone.
700 patients will take part globally in this study, 30 of them will be in the UK.
This is a double blind study, so patients and doctors will not know what treatment patients will receive. Following a screening period, eligible patients will be randomly assigned to either receive BMS-986213 (Nivolumab plus Relatlimab) or Nivolumab through a vein every 4 weeks, during a hospital visit.
Throughout the study, patients will have the following procedures: up to 3 biopsies, CT/MRI scans, physical exams, ECGs, vital signs, blood sampling and pregnancy testing. They will also have to complete questionnaires regularly. They will have follow-up visits after the end of their treatment.
Patients will receive the drugs for as long as they benefit or until they withdraw their consent to receive the study drugs, or they no longer tolerate the study treatment or their cancer progresses.
The study is paid by Bristol-Myers Squibb (BMS).REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/0439
Date of REC Opinion
8 May 2018
REC opinion
Further Information Favourable Opinion