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Monoclonal Antibodies

Evorpacept + Cetuximab + Pembrolizumab for Colorectal Cancer

Phase 2
Waitlist Available
Led By Wells Messersmith, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hematologic and end organ function
Have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

This trial will test a new combo treatment for a particularly stubborn form of colorectal cancer.

Who is the study for?
This trial is for adults with metastatic colorectal cancer that's microsatellite stable and has resisted at least two previous treatments. They must have good blood counts and organ function. It's not for those with certain genetic features (MSI-high or dMMR), severe allergies to study drugs, prior treatment with similar immune-targeting drugs, or specific types of untreated left-sided colorectal cancer.Check my eligibility
What is being tested?
The study tests Evorpacept (ALX148) combined with Cetuximab and Pembrolizumab in patients whose metastatic colorectal cancer hasn't responded to other treatments. This Phase 2 trial aims to see how well these medications work together against this type of cancer.See study design
What are the potential side effects?
Possible side effects include allergic reactions, immune system complications affecting organs, skin problems from cetuximab like acneiform rash, and pembrolizumab-related fatigue, itching or joint pain. Each drug can also cause unique side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood and organs are functioning well.
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I have colorectal cancer that has spread and received at least two treatments.
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My cancer is microsatellite stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR, per RECIST v1.1) (%)
Recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab 1.(mg/kg)
Secondary outcome measures
Disease control rate per RECIST v1.1. (%)
Duration of response per RECIST v1.1. (months)
First cycle dose-limiting toxicities in the safety run-in stage
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Evorpacept (ALX148) + cetuximab + pembrolizumabExperimental Treatment3 Interventions
Evorpacept (ALX148) + cetuximab + pembrolizumab. Evorpacept (ALX148) 15 mg/kg IV weekly, cetuximab 400 mg/m2 once then 250 mg/m2 weekly, and pembrolizumab 200 mg every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Criterium, Inc.Industry Sponsor
16 Previous Clinical Trials
694 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,620 Total Patients Enrolled
Academic GI Cancer Consortium (AGICC)OTHER
2 Previous Clinical Trials
163 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05167409 — Phase 2
Colorectal Cancer Research Study Groups: Evorpacept (ALX148) + cetuximab + pembrolizumab
Colorectal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT05167409 — Phase 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05167409 — Phase 2

Frequently Asked Questions

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

How is ALX148 used to help patients?

"ALX148 is most often used to treat unresectable melanoma. Additionally, this medication can be useful for patients with microsatellite instability high, a high risk of recurrence, and those who cannot tolerate irinotecan."

Answered by AI

Is this a unique clinical trial?

"As of now, 1123 clinical trials for ALX148 are ongoing in 65 nations and 3235 cities. The first trial for this medication was conducted back in 2005 by Bristol-Myers Squibb. It completed Phase 2 drug approval after involving 154 patients. Since then, 616 more trials have been concluded."

Answered by AI

Has ALX148 been cleared by the FDA for public use?

"While there is some data indicating that ALX148 is safe, as this is only a Phase 2 trial, it scored a 2."

Answered by AI

Does the research on ALX148 build upon other scientific literature?

"There are a total of 1123 ongoing clinical trials for ALX148. Of these, 149 are in Phase 3. Most of the trials are being conducted out of Scottsdale, Arizona; however, there are 41336 locations running studies for ALX148."

Answered by AI

Are there any current openings for individuals who want to participate in this trial?

"The clinical trial is actively looking for participants and has been doing so since it was originally posted on 8/1/2022. The most recent update to the listing was on 7/28/2022."

Answered by AI

How many people are being given this experimental medication?

"Yes, the data hosted on clinicaltrials.gov supports that this trial is currently seeking patients. This particular study was posted on August 1st, 2020 and updated as recently as July 28th, 2020. 80 individuals are needed to enroll at 5 different sites."

Answered by AI

In how many different medical care facilities is this clinical trial taking place?

"Currently, this research is taking place in Fairway, New Brunswick, Tucson and 5 additional locations. If you are thinking of participating it might be beneficial to choose the clinical site that is closest to your home to cut down on travel time."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
~16 spots leftby Sep 2024