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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
Must not have
Active infection requiring intravenous systemic therapy
Has evidence of interstitial lung disease or active, non-infectious pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving IV treatment for an infection.
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I have a lung condition not caused by an infection.
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I am unable or unwilling to follow the study's requirements.
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I haven't had major surgery or intense cancer treatment in the last 3 weeks.
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I have been treated with drugs that target the immune system.
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I have been treated with drugs targeting EGFR like cetuximab or panitumumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate
Secondary study objectives
Duration of Response
Length of Overall Survival
Length of Progression Free Survival
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
2017
Completed Phase 3
~7150
Nivolumab
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
364 Previous Clinical Trials
92,328 Total Patients Enrolled
AmgenIndustry Sponsor
1,442 Previous Clinical Trials
1,397,688 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,691 Previous Clinical Trials
4,097,532 Total Patients Enrolled
Michael S. Lee, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Autumn McRee, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
8 Previous Clinical Trials
322 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03442569 — Phase 2
Colon Cancer Research Study Groups: Open-label, single arm, Phase II
Colon Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03442569 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03442569 — Phase 2
~7 spots leftby Dec 2025
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