The SEAMARK Study
Research type
Research Study
Full title
A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB ANDCETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE INPARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT,MSI-H/DMMR METASTATIC COLORECTAL CANCER
IRAS ID
1005249
Contact name
Adam Schayowitz
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2021-003715-26
Clinicaltrials.gov Identifier
Research summary
The purpose of this world-wide 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.
This study is to evaluate whether encorafenib plus cetuximab with pembrolizumab can improve outcomes compared to pembrolizumab alone in previously untreated participants with metastatic colorectal cancer.
All participants in this study will receive pembrolizumab at the study clinic once every 6 weeks 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 once every two weeks 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 for up to about 2 years. Pfizer, Inc is funding the study.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0074
Date of REC Opinion
30 May 2022
REC opinion
Further Information Favourable Opinion