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NCT05710406 Clinical Trial

Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer

Colon Adenocarcinoma Clinical Trial

Official title:
Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage II/III BRAF V600E Colon Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05710406
Other study ID # A022004
Secondary ID NCI-2022-09129
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 30, 2023
Est. completion date August 2034

Study information
Verified date May 2024
Source Alliance for Clinical Trials in Oncology
Contact Rona Yaeger, MD
Phone 646-888-5109
Email yaegerr@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

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Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other • Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events for symptoms of rash, diarrhea, and fatigue summarized for each patient. up to 6 years
Primary Circulating tumor deoxyribonucleic acid (ctDNA) clearance rate (Phase II; ctDNA positive cohort) defined as the proportion of patients with undetectable ctDNA status at 6 months after randomization among patients with detectable ctDNA status at randomization. The ctDNA clearance rate at 6 months after randomization in experimental arm will be compared to control arm by Chi-squared test. The one-sided p-value will be reported. Due to small sample size, Cochran and Mantel-Haenszel test, stratified by stratification factors will be performed as sensitivity analysis. At 6 months after randomization
Primary tDNA recurrence-free survival rate (ctDNA-RFS) (Phase II; ctDNA negative cohort) Defined as the proportion of patients who remained undetectable ctDNA status, recurrence-free, and alive at 6 months after randomization among patients with undetectable ctDNA status at randomization. The ctDNA-RFS in experimental arm will be compared to control arm by Cochran and Mantel-Haenszel test, stratified by stratification factors. The one-sided p-value will be reported. at 6 months after randomization
Primary Disease free survival (DFS) (Phase III) Defined as the time from the date of randomization to the date of first documented recurrence or death due to all cause, whichever occurs first. Patients without events observed at the end of the study will be censored at the date of last disease evaluation which shows no evidence of disease. At each analysis (Interim #1, Interim #2, and Final), stratified Cox model will be conducted to compare DFS in the experimental arm to DFS in the control arm with stratification factors as stratum, based on all data collected at the analysis time point. Assessed up to 6 years after randomization
Secondary Overall Survival Defined as the time from the date of randomization to death due to all causes. The distributions of time-to-event endpoints will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model. Assessed up to 6 years
Secondary Incidence of adverse events after randomization The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be summarized for each patient. The frequency tables will be reviewed to determine the patterns. The overall adverse event rates for grade 4 or higher adverse events will be compared between two treatment groups using Chi-square test (or Fisher's exact test if the data in the contingency table is sparse). up to 6 years
Secondary Alternative disease free survival Defined as the time from the date of primary tumor resection to the date of first documented recurrence or death due to all cause, whichever occurs first. The distributions of time-to-event endpoints will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model. assessed up to 6 years
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