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Nivolumab + Standard Treatment for Colorectal Cancer
Study Summary
This trial is testing whether adding nivolumab to the usual treatment of encorafenib and cetuximab works better at shrinking tumors in patients with colorectal cancer that has spread or cannot be removed by surgery.
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.Side effects data
From 2012 Phase 3 trial • 73 Patients • NCT01177956Trial Design
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Who is running the clinical trial?
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- I have chronic hepatitis B but it's under control with medication.My scans show cancer that cannot be removed or has spread.I have not had any major heart problems recently.I am not on steroids or immunosuppressants for any condition.I have not been treated with specific inhibitors or antibodies.I had hepatitis C but am now cured or have no detectable virus.My blood pressure has been stable for the last month.I have never had a bad reaction to antibody therapy or an organ transplant.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I can swallow and keep down pills.My heart is strong enough for daily activities without discomfort.I have not received a live vaccine in the last 30 days.I had brain surgery or radiation at least 28 days ago and have no neurological symptoms.I do not have HIV and am not on medications that are not allowed in the study.My cancer is microsatellite stable or has proficient mismatch repair.My cancer is confirmed as colon or rectal adenocarcinoma.I am not planning to use other cancer treatments or experimental drugs.My colorectal cancer has a specific BRAF mutation.I do not have another cancer that could affect this treatment's safety or results.My digestive system works well and doesn't affect how my body absorbs medication.I have had 1 or 2 chemotherapy treatments for my advanced cancer that cannot be surgically removed.
- Group 1: Arm I (encorafenib, cetuximab, nivolumab)
- Group 2: Arm II (encorafenib, cetuximab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the governmental authorization status of Cetuximab?
"Cetuximab's safety was given a score of 2 by our team at Power. This is because, although there is some data supporting its safety, none of it points to the medication being effective."
Are you currently looking for participants in this experiment?
"The trial, which is still looking for participants, was first announced on June 6th, 2022 and has had one update on November 11st of the same year."
In how many different geographic areas is this trial being conducted?
"There are 100 sites enrolling patients in this trial. Major cities offering this medication include New york, Miami, and San Francisco."
How many patients are being allowed to enroll in this clinical trial?
"That is correct. The online information portal clinicaltrials.gov has the latest update that this study is still looking for 84 people to participate at 100 different sites. The trial was first posted on 6/6/2022."
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