CA017-055 Nivolumab and BMS-986205 in melanoma
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined with Nivolumab versus Nivolumab in Participants with Metastatic or Unresectable Melanoma that is Previously Untreated.
IRAS ID
235558
Contact name
James Larkin
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-002499-14
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
UTRN, U1111-1197-9148
Duration of Study in the UK
4 years, 10 months, 3 days
Research summary
This is a multicentre, phase 3 study of the investigational drug called Nivolumab, given alone or in combination with another investigational drug called BMS-986205 in patients, who are at least 12 years old, with previously untreated metastatic, or unresectable melanoma.
Nivolumab is a type of immunotherapy drug that is designed to stimulate the body’s own immune system to help attack cancer cells. BMS986-205 helps make cancer cells more sensitive to an attack by the immune system.
This study will assess if BMS-986205 given with Nivolumab delays the progression of previously untreated metastatic, or unresectable melanoma for longer than Nivolumab alone.
933 patients will take part globally in this study, 60 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 Nivolumab with BMS-986205 or Nivolumab with placebo (dummy drug identical to BMS-986205 in taste and in appearance).
All patients will take a dose of BMS-986205 or placebo, as a pill every day after a meal at home, and will receive 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, oxygen saturation, blood sampling and pregnancy testing. They will also have to complete questionnaires regularly and, every day during their treatment, a pill diary. They will have follow-up visits after the end of their treatment.
Patients will receive the drugs for up to 2 years 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
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0643
Date of REC Opinion
8 Jan 2018
REC opinion
Further Information Favourable Opinion