CA224-048 Triple drug combinations in various tumour types
Research type
Research Study
Full title
A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS- 986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
IRAS ID
252055
Contact name
Mark Middleton
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-000058-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 25 days
Research summary
CA224-048 study is designed as a multicentre, phase 1/2 comparing 2 combinations of 3 study drugs, in suitable men and women participants (who are at least 18 yrs or over) and have advanced cancers that may also have spread to other parts of the body. Overall 150 participants will take part in this global study, with an estimate 14 participants coming from the UK.
The study drug combinations used in this study are Relatlimab with Nivolumab and BMS-986205 or Relatlimab with Nivolumab and Ipilimumab.
We know that cancer cells can sometimes go undetected and escape destruction by the immune system. Relatlimab, Nivolumab & Ipilimumab have been developed to modify the immune system, such that cancer cells can be recognised and destroyed.
This study will evaluate if either or both of the above triple drug combinations delay or stop the growth of various cancers. This study has 2 parts:
Part 1 Designed to determine the acceptable dose(s) for the drug combinations in participants with various advanced cancers
Part 2 Examines if either of the drug combinations used, delays or stops the growth of various advanced cancers. UK will only participate in Part 2 of the study, and help gather safety assessments and tolerability of the dose identified in Part 1 of the study.
Participants will complete up to 4 periods of the study: screening, treatment, clinical safety follow-up (FU) and survival FU. A participant in the study will know which study drugs they will receive. Some of the drugs administered via a drip into a vein, whilst others given orally in the form of a pill.
After the treatment period, participants may have tests that can include removing a small amount of tissue (a biopsy). All tests and procedures will be explained and consent sought.The study is sponsored and paid for by Bristol-Myers Squibb (BMS)
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/2015
Date of REC Opinion
20 Dec 2018
REC opinion
Further Information Favourable Opinion