← Back to Search

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 below
Select...
My cancer is microsatellite stable or has normal mismatch repair.
Select...
My cancer does not have mutations in specific genes (KRAS, NRAS, BRAF).
Select...
My kidney function tests are within the required range.
Select...
I am not pregnant and agree to use birth control or abstain from sex during and 5 months after treatment.
Select...
My colorectal cancer is advanced and cannot be removed by surgery.
Select...
My recent liver tests meet the study's requirements.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

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

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 more

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
2020
Completed Phase 3
~6490
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,276 Total Patients Enrolled
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,632 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,458 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic purposes is panitumumab generally employed for?

"Panitumumab is used to treat diseases that have not responded to anti-angiogenic therapies, such as malignant neoplasms and squamous cell carcinoma. It may also be useful for treating unresectable melanomas."

Answered by AI

Are there still opportunities for participants to join this experiment?

"This medical trial is no longer searching for participants. Initially posted on March 9, 2018 and last updated November 11, 2022; alternative trials are available with 243 actively recruiting patients suffering from colon cancer and 796 wherein Panitumumab is being trialled."

Answered by AI

Are there any Canadian sites participating in the trial?

"At present, this medical trial is accepting participants from 5 clinical sites. Indianapolis, Tampa and Seattle are some of the cities hosting these centres while two other locations remain undisclosed. Prospective patients should look for a site close to them in order to lessen travelling requirements."

Answered by AI

Is eligibility for this trial open to me?

"This cancer research is seeking 56 individuals aged between 18 and 120 who are struggling with colon malignancy. The study also requires that patients exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1."

Answered by AI

Has Panitumumab gained sanction from the FDA?

"Despite the lack of evidence for its efficacy, panitumumab is believed to have a certain degree of safety due to being in clinical trials and thus was given a rating of 2."

Answered by AI

Is this trial open to geriatric participants?

"This medical trial is searching for participants who are of legal age or older, but not exceeding 120 years."

Answered by AI

What is the aggregate number of individuals who have enrolled in this research?

"This research project is no longer recruiting participants, having been posted on March 9th 2018 and last updated November 11th 2022. If looking for alternatives studies, there are presently 243 trials concerning colorectal cancer enrolling people and 796 that use Panitumumab as an intervention actively admitting patients."

Answered by AI

Have any other research projects been conducted with Panitumumab?

"Currently, 89 Phase 3 Panitumumab trials are taking place out of the 796 clinical studies that have been set up for this drug. While mostly based in Pittsburgh, Pennsylvania, 43228 different sites offer access to these experiments."

Answered by AI
~8 spots leftby Apr 2025