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Checkpoint Inhibitor
Triple Drug Combo for Colorectal Cancer
Phase 2
Waitlist Available
Led By Michael S. Lee, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Microsatellite stable as detected by PCR-based assay or CLIA-certified sequencing methodology such as Foundation One; or mismatch repair proficient as detected by immunohistochemistry showing intact nuclear staining of MLH1, MSH2, MSH6, and PMS2
Confirmed wild-type in KRAS and NRAS codons 12, 13, 59, 61, 117, and 146; and BRAF codon 600, by standard of care testing of tumor specimen. Tissue used for testing may have been collected from primary or metastatic site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will test a new combination of cancer drugs to see if it is effective in treating subjects with metastatic colorectal cancer who have not responded to other treatments.
Who is the study for?
Adults with specific colorectal cancer that's spread and can't be removed by surgery. They must have normal organ function, no prior treatments with certain antibodies or immune therapies, not pregnant or breastfeeding, and willing to use contraception. Participants need a performance status showing they're relatively active.Check my eligibility
What is being tested?
The trial tests combining Panitumumab (an antibody) with Nivolumab and Ipilimumab (immune checkpoint inhibitors) in patients whose colorectal cancer hasn't responded to treatment and lacks certain genetic mutations (KRAS/NRAS/BRAF wild-type) and is microsatellite stable.See study design
What are the potential side effects?
Possible side effects include skin reactions, fatigue, diarrhea, liver inflammation from Panitumumab; plus immune-related issues like colitis, thyroid problems or lung inflammation from Nivolumab/Ipilimumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is microsatellite stable or has normal mismatch repair.
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My cancer does not have mutations in specific genes (KRAS, NRAS, BRAF).
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My kidney function tests are within the required range.
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I am not pregnant and agree to use birth control or abstain from sex during and 5 months after treatment.
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My colorectal cancer is advanced and cannot be removed by surgery.
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My recent liver tests meet the study's requirements.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Duration of Response
Length of Overall Survival
Length of Progression Free Survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Open-label, single arm, Phase IIExperimental Treatment3 Interventions
Nivolumab and ipilimumab with panitumumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab
2020
Completed Phase 3
~7130
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2610
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
353 Previous Clinical Trials
90,357 Total Patients Enrolled
AmgenIndustry Sponsor
1,383 Previous Clinical Trials
1,379,865 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,776 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving IV treatment for an infection.I am 18 years old or older.I have HIV, HBV, or HCV, or I had HBV or HCV but it's now cleared.I haven't had major surgery or intense cancer treatment in the last 3 weeks.I am a male and will use effective birth control during and for 7 months after the study.My cancer does not have mutations in specific genes (KRAS, NRAS, BRAF).My kidney function tests are within the required range.I am not pregnant and agree to use birth control or abstain from sex during and 5 months after treatment.My colorectal cancer is advanced and cannot be removed by surgery.I haven't needed strong medication for an autoimmune disease in the last 3 months.I've had 1-2 treatments before, or my cancer returned within 6 months after specific chemotherapy.My recent liver tests meet the study's requirements.I can provide tumor tissue samples or agree to a biopsy for the study.I am unable or unwilling to follow the study's requirements.I have brain metastasis that hasn't been treated or was treated within the last 3 months.I haven't had cancer treatment in the last 21 days and have recovered from past treatments.I have a lung condition not caused by an infection.I have another cancer, but it's either inactive or a minor type that doesn't require treatment.My cancer is microsatellite stable or has normal mismatch repair.I have not had an organ transplant, immune system issues, or taken immune-weakening medicines in the last week.I have been treated with drugs that target the immune system.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with drugs targeting EGFR like cetuximab or panitumumab.
Research Study Groups:
This trial has the following groups:- Group 1: Open-label, single arm, Phase II
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.
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