CA209-848 Nivolumab and Ipilimumab in TMB high tumours
Research type
Research Study
Full title
A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination with Ipilimumab or Nivolumab Monotherapy in Participants with Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
IRAS ID
250421
Contact name
Harpreet Wasan
Contact email
Sponsor organisation
Bristol Myers Squibb
Eudract number
2016-002898-35
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CANC 40183, NIHR Number
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is a multicentre, phase 2 study of nivolumab given alone or in combination with ipilimumab in patients with Advanced or Metastatic cancers (metastatic means that the cancer has spread). The cancers must be classified as having a high tumour mutational burden (TMB-H) (please see below).
Recent scientific data has found that patients whose tumours have a lot of DNA mutations may activate the immune system and therefore respond better to immunotherapies such as nivolumab. In order to be eligible for this trial, the patient’s particular cancer must be determined to be TMB-H. This study will assess if nivolumab, given alone or together with ipilimumab, helps reduce the tumour burden of the patient by a certain amount and improve their outcome.
Nivolumab and ipilimumab are immunotherapy drugs designed to stimulate the body’s own immune system to help attack cancer cells.
159 patients, aged 12 years or older (or 18 years in certain geographies) will take part globally in this study; 6 of them will be in the UK.
After a screening period, patients will randomly receive one of the following treatments:
• Nivolumab plus ipilimumab or
• Nivolumab on its own
Both of the drugs are given intravenously (through a vein). This is an open label study, which means both the patient and the doctor will know what treatment(s) they are receiving.
During their study participation, patients will have physical examinations (including vital signs [e.g. heart rate and blood pressure] and weight), scans (i.e. CT scans and/or MRIs), biopsies (if needed), ECGs and blood samples for safety and for study-specific tests. Patients will receive the drugs for up to 24 months, withdrawal of their consent, they are no longer able tolerate the study treatment(s) or their cancer gets worse (whichever comes first).
The study is paid for by Bristol-Myers Squibb (BMS).REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0591
Date of REC Opinion
27 Nov 2018
REC opinion
Favourable Opinion