Ignite Creation Date:
2024-05-06 @ 1:31 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04044430
Status:
TERMINATED
Last Update Posted:
2023-01-09
First Post:
2019-08-01
Brief Title:
Encorafenib Binimetinib and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Phase III Trial of Encorafenib Binimetinib and Nivolumab in Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor funding
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III 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 bodys 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 III 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
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
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2019-04601 | REGISTRY | CTRP Clinical Trial Reporting Program | None |