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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Alternative disease free survival
Incidence of adverse events after randomization
Overall Survival
Other outcome measures
• 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
Encorafenib
2021
Completed Phase 3
~960
Cetuximab
2011
Completed Phase 3
~2480
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,244 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,047 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locations in the state are actively conducting this research?
"This experiment is presently being conducted at 55 different centres, scattered across Canton, Carthage and Decatur as well as other cities. It would be beneficial for participants to choose the closest site to minimize travel requirements when they enroll in this trial."
Answered by AI
Is this medical experiment currently recruiting participants?
"Indeed, current records on clinicaltrials.gov show that this medical trial is open for enrollment. The experiment was first posted in May 30th 2023 and has been revised recently on August 2nd 2023 with the aim of recruiting 394 volunteers across 55 sites worldwide."
Answered by AI
What is the projected enrollment of this trial?
"Affirmative, data available on clinicaltrials.gov reveals that this trial is currently seeking out participants. It was initially posted online on 30th May 2023 and last modified on 2nd August 2023. Participants are being recruited from 55 medical centers with a total of 394 people required for the study."
Answered by AI
Who else is applying?
What site did they apply to?
Emory University Hospital/Winship Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
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