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Checkpoint Inhibitor
Nivolumab Combination Therapy for Colorectal Cancer (CheckMate142 Trial)
Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Histologically confirmed recurrent or metastatic colorectal cancer
Must not have
Active brain metastases or leptomeningeal metastases are not allowed
Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if Nivolumab can effectively treat colon cancer that has returned or spread, specifically in patients whose tumors have a certain biomarker.
Who is the study for?
This trial is for adults with colorectal cancer that has returned or spread, and who haven't been treated for metastatic disease. They should be relatively active (ECOG 0-1), have measurable disease, and tumors with a specific biomarker (microsatellite instability). People can't join if they've had certain cancers in the last 3 years, need steroids or other immune-suppressing drugs, have autoimmune diseases, brain metastases, or previous treatments targeting immune checkpoints.
What is being tested?
The study tests whether Nivolumab alone or combined with Daratumumab, Ipilimumab, BMS-986016, or Cobimetinib shrinks tumors in colon cancer patients. It's exploring different mixtures of these drugs to see which might work best at reducing tumor size when the standard treatment isn’t enough.
What are the potential side effects?
Nivolumab and its combination therapies may cause fatigue, skin reactions like rash or itching; gastrointestinal issues such as diarrhea; liver problems; hormonal gland changes leading to mood swings or tiredness; inflammation of organs like lungs causing coughing or shortness of breath.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My colorectal cancer has returned or spread to other parts.
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My cancer shows microsatellite instability.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have cancer that has spread to my brain or its coverings.
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I have previously been treated with drugs targeting immune system checkpoints.
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I have not had any cancer, except for treatable local cancers, in the last 3 years.
Select...
I haven't taken steroids or immunosuppressants in the last 14 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Nivolumab MonotherapyExperimental Treatment1 Intervention
Nivolumab administered as IV infusion at a dose of 3mg/kg every 2 weeks until disease progression
Group II: Nivolumab + Ipilimumab Cohort C3Experimental Treatment2 Interventions
Group III: Nivolumab + Ipilimumab + Cobimetinib Cohort C4Experimental Treatment3 Interventions
Group IV: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group V: Nivolumab + Daratumumab Cohort C6Experimental Treatment2 Interventions
Group VI: Nivolumab + BMS-986016 Cohort C5Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Daratumumab
2014
Completed Phase 3
~2380
Ipilimumab
2015
Completed Phase 3
~3420
BMS-986016
2018
Completed Phase 2
~520
Cobimetinib
2017
Completed Phase 3
~3630
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,686 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have previously been treated with drugs targeting immune system checkpoints.I haven't taken steroids or immunosuppressants in the last 14 days.I do not have cancer that has spread to my brain or its coverings.You have a condition where your immune system attacks your own body and it is currently active or suspected to be active.I have not had any cancer, except for treatable local cancers, in the last 3 years.My cancer shows microsatellite instability.My colorectal cancer has returned or spread to other parts.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab + Ipilimumab + Cobimetinib Cohort C4
- Group 2: Nivolumab + Daratumumab Cohort C6
- Group 3: Nivolumab Monotherapy
- Group 4: Nivolumab + Ipilimumab
- Group 5: Nivolumab + Ipilimumab Cohort C3
- Group 6: Nivolumab + BMS-986016 Cohort C5
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.