The CheckMate 8HW study: 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)

Locations: BC, AB, ON, QC

Status: currently recruiting

Trial description: The purpose of this study is to compare the clinical benefits and compare the efficacy (how well the drug works), harmlessness (safety), and tolerability of the immunotherapy drug nivolumab in combination with the immunotherapy drug ipilimumab OR by nivolumab alone among patients with Microsatellite-Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare the effectiveness of nivolumab and the combination of nivolumab and ipilimumab with the effectiveness of chemotherapy (the standard treatment).

Clinical benefit is measured by:

• Progression-Free Survival: the length of time during and after treatment of the cancer that a patient lives with the disease but it does not worsen
• Objective Response Rate: the percentage of people who have a partial or complete response to treatment in a specific period of time
• Overall Survival: the length of time from diagnosis/start of treatment that patients are still alive

Who is eligible to participate in this study?

• Participants must be 18 years or older
• Have recurrent or metastatic colorectal cancer (mCRC)
• Can have received previous treatment with chemotherapy and/or targeted therapies, or no previous treatment
• Known tumour microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status
• Able to perform light to moderate physical activity without restriction

What does participation in this study look like?

Participants will be randomly assigned to one of three study groups:

• Experimental Arm A: Participants will receive nivolumab alone
• Experimental Arm B: Participants will receive nivolumab in combination with ipilimumab
• Control arm: Participants will receive standard chemotherapy (oxaliplatin, leucovorin, fluorouracil, irinotecan plus bevacizumab/cetuximab) and would be allowed to receive nivolumab + ipilimumab if their disease worsens

How much does it cost to participate?

There is no cost associated with enrollment in this study, however, there may be indirect costs such as parking fees.

If you would like to learn more about the CheckMate 8HW study, please email or call the study team.

Contact information:

BMS Study Connect Contact Center

Email: www.BMSStudyConnect.com

Note: First line of the email MUST contain NCT # NCT04008030 and Site # (refer to link below to determine the desired site # under “Locations”.

Telephone: 855-907-3286

Full trial description: https://clinicaltrials.gov/ct2/show/NCT04008030