Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05217446
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2022-01-19
Brief Title:
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 2 RANDOMIZED OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT MSI HDMMR METASTATIC COLORECTAL CANCER
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEAMARK
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003715-26 | EUDRACT_NUMBER | None | None |
| SEAMARK | OTHER | None | None |
| MK-3475-D31 | OTHER | None | None |
| KEYNOTE-D31 | OTHER | Merck | None |