CA209-76K Nivolumab vs Placebo in early-stage Melanoma
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CA209-76K)
IRAS ID
270232
Contact name
Head of Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-001230-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
115,195, IND Number; 41548, NIHR CPMS ID
Duration of Study in the UK
4 years, 4 months, 8 days
Research summary
This is a multicentre, phase 3 study to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab. The study is for patients with early stage (IIB/C) melanoma (a type of skin cancer) who have had their tumours completely removed via surgery, but could possibly have their cancer return in the future.
Nivolumab is a type of immunotherapy drug that is designed to boost the body’s own immune system to fight cancer cells.
Around 1000 participants over the age of 12 will be enrolled in this study, with approximately 50 patients participating from the UK. Participants will be randomly assigned to one of two treatment arms to receive either nivolumab (66% chance) or placebo (33% chance). A placebo is a “dummy treatment” that looks like the real one but contains no active study drug.
Participants will receive study treatment for a maximum of 12 months, and will then enter an initial follow up phase of up to approximately 100 days, then an additional follow up period of up to approximately 5 years. The treatment will be blinded, i.e., neither the participants, nor the study doctor will know which treatment the participant is receiving. Participants who have their cancer return and meet certain criteria, may be able to receive nivolumab as part of this study.
Participants will undergo the following procedures during the study: imaging assessments (CT/MRI scans), physical examinations, provide urine blood samples for routine safety and study-specific testing and complete questionnaires relating to their health/quality of life. Participants will also need to have adequate tumour sample from previous surgery or biopsy.
This study is sponsored by Bristol-Myers Squibb.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0219
Date of REC Opinion
6 Dec 2019
REC opinion
Further Information Favourable Opinion