Clinical Trials Directory

Trials / Terminated

TerminatedNCT04044430

Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer

Phase I/II Trial of Encorafenib, Binimetinib, and Nivolumab in Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
2 (actual)
Sponsor
University of California, San Francisco · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib 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, binimetinib, and nivolumab may work better in treating patients with colorectal cancer compared to standard treatments.

Detailed description

This was intended to be a phase I/II study of Encorafenib, Binimetinib, and Nivolumab for treating participants with Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer. The study was terminated before Phase II was initiated. The study did not open Phase II for enrollment. PRIMARY OBJECTIVES: I. To describe overall response rate (ORR) upon treatment with encorafenib, binimetinib, and nivolumab in patients with BRAFV600E, microsatellite stable (MSS) metastatic colorectal cancer (mCRC). II. To determine the safety and tolerability of nivolumab, encorafenib, and binimetinib in patients with BRAFV600E, MSS mCRC. SECONDARY OBJECTIVES: I. To estimate median progression-free survival (PFS) upon treatment with encorafenib, binimetinib, and nivolumab. II. To estimate median overall survival (OS) upon treatment with encorafenib, binimetinib, and nivolumab. III. To estimate median time to response (TTR) upon treatment with encorafenib, binimetinib, and nivolumab. IV. To estimate median duration of response (DoR) upon treatment with encorafenib, binimetinib, and nivolumab. V. To estimate disease control rate (DCR) upon treatment with encorafenib, binimetinib, and nivolumab. EXPLORATORY (CORRELATIVE) OBJECTIVES: I. To assess genomic and immune changes upon treatment with encorafenib, binimetinib, and nivolumab in tumor tissue, blood and stool. II. To correlate genomic and immune changes upon treatment with encorafenib, binimetinib, and nivolumab in tumor tissue, blood and stool with radiographic response. III. To evaluate contrast-enhanced computed tomography (CT) imaging for disease burden that is not measurable by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) and to correlate location and patterns of metastatic disease with clinical outcomes. OUTLINE: Participants in received encorafenib orally (PO) once daily (QD) on days 1-28, binimetinib PO twice daily (BID) on days 1-28, and nivolumab intravenously (IV) on day 1. Cycles repeat every 28 days for a maximum of 24 cycles of treatment. If disease progression or recurrence occurs, treatment may be resumed outside of the context of the clinical trial. After completion of study treatment, patients are followed up at 30 and 100 days, then every 3 months thereafter. Only participants in Phase 1 were enrolled.

Conditions

Interventions

TypeNameDescription
DRUGBinimetinibGiven PO
DRUGEncorafenibGiven PO
BIOLOGICALNivolumabGiven IV
OTHERQuestionnaire AdministrationAncillary studies

Timeline

Start date
2020-08-31
Primary completion
2022-07-31
Completion
2022-07-31
First posted
2019-08-05
Last updated
2023-01-09

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04044430. Inclusion in this directory is not an endorsement.