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Monoclonal Antibodies
Encorafenib + Cetuximab + Nivolumab for Colorectal Cancer
Phase 1 & 2
Recruiting
Led By Van K Morris
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum Creatinine ≤ 1.5 x ULN, or calculated creatinine clearance (determined as per Cockcroft-Gault) ≥ 50mL/min at screening;
Histologically (or cytologically) confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or metastatic disease that is measurable according to RECIST1.1 criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat patients with colorectal cancer that has spread and cannot be removed by surgery. The drugs work by blocking enzymes needed for cell growth and by helping the body's immune system attack the cancer.
Who is the study for?
Adults with microsatellite stable, BRAFV600E mutated colorectal cancer that's inoperable or has spread can join. They must be able to take pills, have certain blood and organ function levels, not be pregnant or fathering a child, and agree to use contraception. Exclusions include HIV, hepatitis B/C infection, uncontrolled hypertension, recent live vaccines, certain heart conditions, brain metastases symptoms.Check my eligibility
What is being tested?
The trial is testing the combination of encorafenib (blocks enzymes for cell growth), cetuximab (stops tumor cells), and nivolumab (boosts immune attack on cancer) in patients with specific colorectal cancer. It aims to find the best dose and observe side effects compared to using cetuximab alone.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to monoclonal antibodies like nivolumab and cetuximab; skin issues from encorafenib; plus common chemotherapy-related effects such as fatigue, digestive problems, blood disorders which could affect organ functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
My colon or rectum cancer is confirmed, cannot be surgically removed, and can be measured.
Select...
My tumor has the BRAFV600E mutation as confirmed by a certified lab.
Select...
My cancer is microsatellite stable (MSS) as confirmed by a certified lab.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best radiographic response
Incidence of treatment-related grade 3 adverse events
Secondary outcome measures
Duration of response
Overall survival
Progression-free survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (encorafenib, cetuximab, nivolumab)Experimental Treatment3 Interventions
Patients receive encorafenib PO QD on days 1-28, cetuximab IV over 1 hour on days 1 and 15, and nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,283 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,035 Total Patients Enrolled
Van K MorrisPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,566 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My stomach or intestines do not work well, affecting how I absorb medicine.I have previously been treated with a BRAF, MEK, or ERK inhibitor.I had severe side effects from previous cancer treatments targeting specific genes.My kidney function, measured by creatinine levels, is within the normal range.My blood tests show my organs and bone marrow are working well.You have a medical, psychological, or cognitive condition that may affect your ability to understand the study information, give informed consent, follow the study's instructions, or complete the study.I am not pregnant or at risk of becoming pregnant, or I agree to use birth control during the study.I have brain metastases but no current symptoms without needing steroids or anti-seizure meds.I do not have inflammatory bowel disease or autoimmune conditions, except for Graves' disease.I have had pancreatitis but no attacks in the last 2 years.I haven't had cancer, except for certain skin cancers or other minor cancers, in the last 3 years.My blood pressure is very high despite taking medication.I have had a transplant of tissue or an organ from another person.I can take pills by mouth.I am not on steroids or immunosuppressants, except for low-dose daily steroid replacement.I have previously been treated with anti-EGFR therapies.I have previously received immunotherapy for cancer treatment.I have not received a live vaccine in the last 30 days, except for the seasonal flu shot.I have had a severe allergic reaction to certain antibody treatments.I am currently taking antibiotics for an infection.My cancer has spread to the lining of my brain and spinal cord.My heart health is good and I don't have major heart diseases.I haven't had a heart attack or any major heart procedure in the last 6 months.I do not have serious heart issues like chronic heart failure or arrhythmias in the last 6 months.I have not had major surgery in the last 6 weeks or still have side effects from it.My colon or rectum cancer is confirmed, cannot be surgically removed, and can be measured.I am 18 years old or older.My tumor has the BRAFV600E mutation as confirmed by a certified lab.My cancer is microsatellite stable (MSS) as confirmed by a certified lab.I have had 1-2 chemotherapy treatments for metastatic colorectal cancer or it came back within 6 months after surgery.I have had treatments targeting specific genes for my colorectal cancer.I am fully active and can carry on all my pre-disease activities without restriction.I have had pneumonitis treated with steroids.If the doctor thinks that it's not safe for you to participate in the study or you may not be able to follow the study procedures, you will not be allowed to join.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (encorafenib, cetuximab, nivolumab)
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.
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT04017650 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What past examinations have been conducted centering on Cetuximab?
"Presently, 851 trials are running on Cetuximab with 112 of them in the latter Phase 3. While most of these studies have been based out of Pittsburgh, Pennsylvania there is an expansive network encompassing over 46,000 sites testing this medication."
Answered by AI
To what extent is this experiment involving human test subjects?
"Correct. Data hosted on clinicaltrials.gov indicates that this medical investigation, which was initially posted on June 14th 2019, is still actively looking for enrollees. About 38 patients need to be enlisted from a single site."
Answered by AI
Are there any open slots available for the research trial?
"As per clinicaltrials.gov, this particular medical trial is seeking new members to join their research team and is currently open for recruitment. This experiment was first posted on June 14th 2019 with the most recent modifications occurring August 31st 2022."
Answered by AI
To what ailments are practitioners most often prescribing Cetuximab?
"Cetuximab can be deployed to treat unresectable melanoma, squamous cell carcinomas, and those at an elevated risk of relapse."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I saw this trial and was interested in it. I have Stage 4 Colon Cancer that metastasized to my liver where I had 7 lesions but after 6 months of chemotherapy I am down to 3 lesions in my liver. However, the chemotherapy is wearing me down. I hurt all over, most the time I just want to sleep all day because I am so tired. I am still working a full time job but financially, physically and mentally I can not do another 6 months of the 5FU chemotherapy. I am just looking into this trial to see if it would get rid of my last 3 lesions faster without as many side affects. My CEA level is currently at 3.5 and it started at 57.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
If I am able to do the trial will you provide a place to stay while I am in Texas?
PatientReceived 2+ prior treatments
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