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Encorafenib + Cetuximab for Colorectal Cancer
Study Summary
This trial is testing a new combination of drugs to treat colorectal cancer that has spread and has a certain type of abnormal gene. The new combination is encorafenib plus cetuximab, which will be taken either alone or with standard chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am eligible for a Phase 3 trial with no specific requirements.My colorectal cancer is stage IV with a BRAF V600E mutation.I have received treatment for cancer after it spread.I have been treated with up to 1 type of therapy for my condition.I have had up to one previous systemic therapy.My cancer can be measured or evaluated by tests.My organs are working well.My colorectal cancer is stage IV with a BRAF V600E mutation.I am 18 years old or older.I am 16 years or older.I am 18 years old or older.I am fully active or can carry out light work.My cancer returned within 6 months after completing early-stage treatment.I am eligible for a Phase 3 trial with no specific requirements.My tumor is MSI-H/dMMR, and I can't take immune checkpoint inhibitors due to a health condition.I have not had any bacterial or viral infections in the last 2 weeks.I have brain metastases that are causing symptoms.I am 16 years old or older.I have received systemic treatment for cancer that has spread.
- Group 1: Safety Lead-in Cohort 1
- Group 2: Safety Lead-in Cohort 2
- Group 3: Phase 3 Arm A
- Group 4: Phase 3 Arm B
- Group 5: Phase 3 Arm C
- Group 6: Cohort 3 Arm D
- Group 7: Cohort 3 Arm E
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
How many people are included in the scope of this research?
"The sponsor, Ono Pharmaceutical Co. Ltd., needs to recruit 765 patients that fit the clinical study's inclusion criteria from locations including The University of Chicago Medicine Center for Advanced Care Orland Park in Orland Park, Illinois and UChicago Medicine at Ingalls - Tinley Park in Tinley Park, Ontario."
What is the official government stance on Cetuximab?
"Cetuximab has received a 3 for safety from our Power team. This is due to the fact that it is a Phase 3 trial, which means that there is not only some data supporting efficacy, but multiple rounds of data affirming its safety."
What are the conditions that Cetuximab is most commonly used to target?
"Cetuximab can be used as a treatment for small cell lung cancer, unresectable melanoma, and rectal carcinoma."
In how many total places is this research being conducted?
"There are 100 clinical trial sites operational for this study, including The University of Chicago Medicine Center for Advanced Care Orland Park in Orland Park, UChicago Medicine at Ingalls - Tinley Park in Tinley Park, and London Regional Cancer Program, London Health Sciences Centre in London."
Are researchers still looking for volunteers for this clinical trial?
"Yes, this is an ongoing study that is recruiting patients from 100 different sites. The trial was posted on December 21st 2020 and the most recent update was on October 4th, 2022. They are looking to enroll 765 people in total."
What does the research say about Cetuximab's efficacy?
"Cetuximab is being trialed in 1275 active studies, with the majority of Phase 3 trials taking place in Guangzhou, Guangdong. In total, there are 51069 locations worldwide where Cetuximab clinical trials are running."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- Barnes- Jewish Hospital: < 48 hours
Average response time
- < 2 Days
Typically responds via
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