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BRAF-Targeted Therapy for Colon Cancer
Phase 2 & 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Summary
This trial compares encorafenib + cetuximab (which may stop tumor growth) to usual care for reducing colon cancer recurrence after standard surgery + chemo.
Who is the study for?
This trial is for adults with stage IIB-III colon cancer that has been surgically removed and treated with specific chemotherapy. Participants must have a BRAF V600E mutation, stable microsatellite status, proper organ function, no severe heart conditions or uncontrolled hypertension, not be pregnant or nursing, and cannot have other active cancers or serious medical issues.
What is being tested?
The study compares the effectiveness of encorafenib plus cetuximab (targeting enzymes and proteins to stop tumor growth) against usual care after surgery and chemotherapy in preventing cancer recurrence in patients with certain genetic mutations in their colon cancer.
What are the potential side effects?
Encorafenib can cause fatigue, joint pain, skin changes, hair loss; Cetuximab may lead to an acne-like rash on the face and chest, tiredness, nausea. Both drugs might affect liver enzymes and could potentially prolong QT interval leading to heart rhythm problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Circulating tumor deoxyribonucleic acid (ctDNA) clearance rate (Phase II; ctDNA positive cohort)
Disease free survival (DFS) (Phase III)
tDNA recurrence-free survival rate (ctDNA-RFS) (Phase II; ctDNA negative cohort)
Secondary study objectives
Alternative disease free survival
Incidence of adverse events after randomization
Overall Survival
Other study objectives
• Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events for symptoms of rash, diarrhea, and fatigue
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (encorafenib, cetuximab)Experimental Treatment5 Interventions
Patients receive encorafenib PO and cetuximab IV on study. Patients also undergo collection of blood samples throughout the study and CT or MRI during screening and follow-up.
Group II: Arm II (patient observation)Active Control4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Cetuximab
2011
Completed Phase 3
~2480
Computed Tomography
2017
Completed Phase 2
~2740
Biospecimen Collection
2004
Completed Phase 3
~2020
Encorafenib
2022
Completed Phase 3
~970
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,078 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,606 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is microsatellite stable.I don't have any severe health issues like uncontrolled infections or heart disease.My blood pressure is under control.My heart function is classified as class 2B or better, despite my history of cardiac issues or treatments.My cancer's BRAF V600 status has been or will be tested.I've completed at least 3 months of specific chemotherapy for my cancer.I am not taking medications that can cause heart rhythm problems.I have no active cancer except for non-dangerous skin cancer or treated cervical cancer.I have not received any treatments for my current colon cancer.I am not taking strong CYP3A4 inducers, or I can stop them 14 days before the study starts.My cancer is at stage III or high-risk stage II.My cancer is located in the colon.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I am 18 years old or older.I am able to care for myself and perform daily activities.I can swallow pills without any medical issues.My cancer has the BRAF V600E mutation.My colon cancer is stage III or high-risk stage II and was completely removed.My cancer is not active if it was a small carcinoid, non-invasive breast or endometrial cancer.I am not taking strong CYP3A4 inhibitors, or can stop them 14 days before the study.I finished my additional cancer treatment less than 8 weeks ago.I don't have lasting side effects from past chemotherapy, except for possible hair loss or nerve pain.I am not pregnant or breastfeeding and, if capable of bearing children, have a recent negative pregnancy test.My kidney function, measured by creatinine clearance, is good.I had a noninvasive skin cancer that is not currently active.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (encorafenib, cetuximab)
- Group 2: Arm II (patient observation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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