CWoW - CA209-8HW Nivolumab, Ipilimumab, chemotherapy in participants with mCC
Research type
Research Study
Full title
A Phase 3b Randomized Clinical Trial of Nivolumab alone, Nivolumab in Combination with Ipilimumab, or an Investigator’s Choice Chemotherapy in Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer
IRAS ID
269702
Contact name
Head of Global Clinical Trial Submission Unit
Contact email
Sponsor organisation
Bristol Mayers Squibb
Eudract number
2018-000040-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
119,381, IND Number
Duration of Study in the UK
5 years, 7 months, 12 days
Research summary
This is a multicentre, phase 3 study in patients with colorectal cancer known as Metastatic Colorectal Cancer (mCRC), i.e., cancer that has spread to other parts of the body. This study will evaluate whether treatment with nivolumab plus ipilimumab will improve progression-free survival (PFS) when compared with nivolumab on its own in participants with mCRC.
PFS means the length of time a patient lives with their cancer from the point of diagnosis or start of treatment without it getting worse.
494 patients will be enrolled in this study globally, with 12 patients in the UK. Participants will be randomly (by chance) assigned to 3 treatment arms:
Arm A: Nivolumab
Arm B: Nivolumab + ipilimumab
Arm C: Investigator’s choice chemotherapy (standard of care)In addition, participants in Arm C who experience disease progression (when the cancer worsens) on or after treatment will be able to switch treatment to receive both nivolumab and ipilimumab, this group will be known as the Crossover Cohort.
This study is open-label, meaning that both the patient and their study doctor will know which treatment they are receiving.
Patients will receive treatment until disease progression, discontinuation for other reasons or reaching the maximum treatment duration. Patients in Arms A and B will be in the study for a maximum period of 2 years, except for patients with late response during second year of treatment, who will continue for up to an additional year. Patients in Arm C will have a maximum treatment duration of 2 years; those who enroll in the Crossover Cohort will have an additional 2 years’ treatment from the first dose in the Crossover Cohort.
Participants will undergo the following procedures during the study: at least one biopsy if they do not have adequate tumour sample from a previous biopsy, imaging assessments, physical examinations, blood, urine and stool sampling for routine safety and study-specific testing, and questionnaire completion.
This study is sponsored by Bristol-Myers Squibb.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0561
Date of REC Opinion
29 Oct 2019
REC opinion
Further Information Favourable Opinion