Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer
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ClinicalTrials.gov Identifier: NCT05710406 |
Recruitment Status :
Recruiting
First Posted : February 2, 2023
Last Update Posted : April 9, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | January 24, 2023 | ||||||||
First Posted Date ICMJE | February 2, 2023 | ||||||||
Last Update Posted Date | April 9, 2024 | ||||||||
Actual Study Start Date ICMJE | May 30, 2023 | ||||||||
Estimated Primary Completion Date | August 2034 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
• Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events for symptoms of rash, diarrhea, and fatigue [ Time Frame: up to 6 years ] summarized for each patient.
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer | ||||||||
Official Title ICMJE | Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage II/III BRAF V600E Colon Cancer | ||||||||
Brief Summary | This phase II/III 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
394 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | August 2034 | ||||||||
Estimated Primary Completion Date | August 2034 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: N/A |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT05710406 | ||||||||
Other Study ID Numbers ICMJE | A022004 NCI-2022-09129 ( Other Identifier: NCI Clinical Trial Reporting Program ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Alliance for Clinical Trials in Oncology | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Alliance for Clinical Trials in Oncology | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Alliance for Clinical Trials in Oncology | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |