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Be Part of Research - Trial Details - A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Colorectal Neoplasms
Microsatellite Instability


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2019 Aug 2024

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Specified dose on specified days

Intervention Arm Group : Arm B: Nivolumab + Ipilimumab Combination;

Intervention Type : DRUG
Intervention Description : Specified dose on specified days

Intervention Arm Group : Arm C: Investigator's Choice Chemotherapy;

Intervention Type : DRUG
Intervention Description : Specified dose on specified days

Intervention Arm Group : Arm C: Investigator's Choice Chemotherapy;

Intervention Type : DRUG
Intervention Description : Specified dose on specified days

Intervention Arm Group : Arm C: Investigator's Choice Chemotherapy;

Intervention Type : DRUG
Intervention Description : Specified dose on specified days

Intervention Arm Group : Arm C: Investigator's Choice Chemotherapy;

Intervention Type : DRUG
Intervention Description : Specified dose on specified days

Intervention Arm Group : Arm C: Investigator's Choice Chemotherapy;

Intervention Type : DRUG
Intervention Description : Specified dose on specified days

Intervention Arm Group : Arm C: Investigator's Choice Chemotherapy;

Intervention Type : BIOLOGICAL
Intervention Description : Specified dose on specified days

Intervention Arm Group : Arm A: Nivolumab Monotherapy;Arm B: Nivolumab + Ipilimumab Combination;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Local Institution - 0127
    London
    EC1A 7BE
  • Local Institution - 0049
    Oxford
    OX3 7LE


The study is sponsored by Bristol-Myers Squibb and is in collaboration with Ono Pharmaceutical Co. Ltd.




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Read full details for Trial ID: NCT04008030
Last updated 24 February 2025

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