Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05710406
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2023-01-24
Brief Title:
Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage IIIII BRAF V600E Colon Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IIIII trial compares treatment with encorafenib and cetuximab to usual care patient observation for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer Encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Cetuximab is in a class of medications called monoclonal antibodies It binds to a protein called EGFR which is found on some types of tumor cells This may help keep tumor cells from growing Giving encorafenib and cetuximab after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation
Detailed Description:
The primary and secondary objectives of the study
PRIMARY OBJECTIVES
I To evaluate and compare 6 month circulating tumor deoxyribonucleic acid ctDNA clearance rate in study patients with detectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy Phase II II To evaluate and compare 6 month ctDNA recurrence-free survival ctDNA-RFS rate in study patients with undetectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy Phase II III To evaluate and compare disease-free survival DFS measured from randomization in patients with resected stage III or high-risk pT4 stage II mismatch repair protein MMR proficient BRAF V600E colon cancer treated with targeted BRAF therapy versus usual care after standard adjuvant chemotherapy Phase III
SECONDARY OBJECTIVES
I To evaluate and compare overall survival OS between the two treatment arms
II To evaluate and compare the toxicity profile between the two treatment arms
III To evaluate and compare the alternative DFS endpoint measured from date of primary tumor resection between the two treatment arms
IV To evaluate and compare DFS in the subset of patients with detectable ctDNA prior to randomization between the two treatment arms
EXPLORATORY OBJECTIVE
I To evaluate and compare patient-reported outcomes for symptoms of rash diarrhea and fatigue according to Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events PRO-CTCAE between the two treatment arms
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive encorafenib orally PO and cetuximab intravenously IV on study Patients also undergo collection of blood samples throughout the study and computed tomography CT or magnetic resonance imaging MRI during screening and follow-up
ARM II Patients undergo observation per usual care on study Patients also undergo collection of blood samples throughout the study and CT or MRI during screening and follow-up
PRIMARY OBJECTIVES
I To evaluate and compare 6 month circulating tumor deoxyribonucleic acid ctDNA clearance rate in study patients with detectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy Phase II II To evaluate and compare 6 month ctDNA recurrence-free survival ctDNA-RFS rate in study patients with undetectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy Phase II III To evaluate and compare disease-free survival DFS measured from randomization in patients with resected stage III or high-risk pT4 stage II mismatch repair protein MMR proficient BRAF V600E colon cancer treated with targeted BRAF therapy versus usual care after standard adjuvant chemotherapy Phase III
SECONDARY OBJECTIVES
I To evaluate and compare overall survival OS between the two treatment arms
II To evaluate and compare the toxicity profile between the two treatment arms
III To evaluate and compare the alternative DFS endpoint measured from date of primary tumor resection between the two treatment arms
IV To evaluate and compare DFS in the subset of patients with detectable ctDNA prior to randomization between the two treatment arms
EXPLORATORY OBJECTIVE
I To evaluate and compare patient-reported outcomes for symptoms of rash diarrhea and fatigue according to Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events PRO-CTCAE between the two treatment arms
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive encorafenib orally PO and cetuximab intravenously IV on study Patients also undergo collection of blood samples throughout the study and computed tomography CT or magnetic resonance imaging MRI during screening and follow-up
ARM II Patients undergo observation per usual care on study Patients also undergo collection of blood samples throughout the study and CT or MRI during screening and follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| NCI-2022-09129 | OTHER | NCI Clinical Trial Reporting Program | None |