Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT04017650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2019-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I/II Trial of Encorafenib, Cetuximab, and Nivolumab in Microsatellite Stable BRAFV600E Metastatic Colorectal Cancer (BMS-MDACC CA209-8P6/ARRAY IST-818-101X)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
None
Brief Summary:
This phase I/II trial studies the best dose and side effects of encorafenib, cetuximab, and nivolumab and how well they work together in treating patients with microsatellite stable, BRAFV600E gene mutated colorectal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Encorafenib and cetuximab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.Giving encorafenib, cetuximab, and nivolumab may work better in treating patients with colorectal cancer compared to cetuximab alone.
Detailed Description:
PRIMARY OBJECTIVES:
I. To describe overall response rate (ORR) upon treatment with encorafenib, cetuximab, and nivolumab.
II. To determine the safety and tolerability of nivolumab, encorafenib, and cetuximab.
SECONDARY OBJECTIVES:
I. To estimate median progression-free survival (PFS) upon treatment with encorafenib, cetuximab, and nivolumab.
II. To estimate median overall survival (OS) upon treatment with encorafenib, cetuximab, and nivolumab.
III. To estimate median time to response (TTR) upon treatment with encorafenib, cetuximab, and nivolumab.
IV. To estimate median duration of response (DOR) upon treatment with encorafenib, cetuximab, and nivolumab.
V. To estimate disease control rate (DCR) upon treatment with encorafenib, cetuximab, and nivolumab.
EXPLORATORY OBJECTIVES:
I. To assess genomic and immune changes upon treatment with encorafenib, cetuximab, and nivolumab.
II. To demonstrate feasibility of establishing humanized patient-derived xenograft models in matched patients with BRAFV600E metastatic colorectal cancer (mCRC).
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive encorafenib orally (PO) once daily (QD) on days 1-28, cetuximab intravenously (IV) over 1 hour on days 1 and 15, and nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 100 days, at 3 months, and then every 3 months thereafter.
I. To describe overall response rate (ORR) upon treatment with encorafenib, cetuximab, and nivolumab.
II. To determine the safety and tolerability of nivolumab, encorafenib, and cetuximab.
SECONDARY OBJECTIVES:
I. To estimate median progression-free survival (PFS) upon treatment with encorafenib, cetuximab, and nivolumab.
II. To estimate median overall survival (OS) upon treatment with encorafenib, cetuximab, and nivolumab.
III. To estimate median time to response (TTR) upon treatment with encorafenib, cetuximab, and nivolumab.
IV. To estimate median duration of response (DOR) upon treatment with encorafenib, cetuximab, and nivolumab.
V. To estimate disease control rate (DCR) upon treatment with encorafenib, cetuximab, and nivolumab.
EXPLORATORY OBJECTIVES:
I. To assess genomic and immune changes upon treatment with encorafenib, cetuximab, and nivolumab.
II. To demonstrate feasibility of establishing humanized patient-derived xenograft models in matched patients with BRAFV600E metastatic colorectal cancer (mCRC).
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive encorafenib orally (PO) once daily (QD) on days 1-28, cetuximab intravenously (IV) over 1 hour on days 1 and 15, and nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 100 days, at 3 months, and then every 3 months thereafter.
Study Oversight
Has Oversight DMC:
False
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?: