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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

Have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease

Have microsatellite stable disease

Must not have

Patients in whom both mismatch repair and microsatellite stability status are unknown

Patients with known MSI-high status or known mismatch repair deficiency (dMMR)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

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.

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.

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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I have colorectal cancer that has spread and received at least two treatments.

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My cancer is microsatellite stable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't know my cancer's mismatch repair or microsatellite status.

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My cancer is MSI-high or has mismatch repair deficiency.

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I have previously been treated with specific immune therapy drugs.

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My colorectal cancer is on the left side, has not spread, and I haven't had EGFR inhibitor treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR, per RECIST v1.1) (%)

Recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab 1.(mg/kg)

Secondary study objectives

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

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: 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

Pembrolizumab

2017

Completed Phase 3

~2810

Cetuximab

2011

Completed Phase 3

~2480