Encorafenib + Cetuximab and Pembrolizumab for Colorectal Cancer
(SEAMARK Trial)

Recruiting in Palo Alto (17 mi)

+114 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) * has a certain type of abnormal gene called "BRAF" and; * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Eligibility Criteria

This trial is for adults with metastatic colorectal cancer that has specific genetic features (MSI-H/dMMR and BRAF V600E mutation), no prior treatments for metastatic disease, good performance status (ECOG 0 or 1), measurable disease, and adequate organ function. It excludes those with certain mutations, brain metastases, pancreatitis, recent live vaccines, previous treatment with similar drugs or immunotherapies.

Inclusion Criteria

I haven't had any systemic treatments for my cancer since it spread.

Measurable disease per RECIST 1.1

I am fully active or can carry out light work.

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Exclusion Criteria

I have not received a live vaccine in the last 30 days.

I have pancreatitis.

My cancer has spread to my brain or its coverings.

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Treatment Details

Interventions

Cetuximab (Monoclonal Antibodies)
Encorafenib (Kinase Inhibitor)
Pembrolizumab (PD-1 Inhibitor)

Trial OverviewThe study tests the combination of Encorafenib plus Cetuximab taken orally at home along with Pembrolizumab given via IV at a clinic compared to just Pembrolizumab alone. The goal is to see if this combo is more effective in treating patients who haven't had any previous systemic treatments for their advanced colorectal cancer.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: encorafenib, cetuximab and pembrolizumabExperimental Treatment3 Interventions

Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.

Group II: Arm B: pembrolizumabActive Control1 Intervention

Participants receive pembrolizumab IV.

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erbitux for:

Locally or regionally advanced squamous cell carcinoma of the head and neck
Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
BRAF V600E mutation-positive metastatic colorectal cancer

🇪🇺 Approved in European Union as Erbitux for: