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Monoclonal Antibodies
Triple Drug Therapy for Colorectal Cancer
Phase 2
Waitlist Available
Led By Christopher Lieu, MD
Research Sponsored by University of Colorado, Denver
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 study beginning to study end; 12 months
Awards & highlights
Summary
This trial is testing a new combination of drugs for people with metastatic colorectal adenocarcinoma who have not responded to other treatments.
Who is the study for?
Adults with metastatic colorectal adenocarcinoma who've had at least two prior treatments without success. They must be in relatively good health, able to follow the study plan, and willing to use effective contraception. Excluded are those with significant heart or lung issues, recent serious medical events like a stroke, uncontrolled high blood pressure, certain other cancers within 3 years, untreated brain metastases, severe allergies to trial drugs or components.
What is being tested?
The trial is testing a combination of three drugs: Pembrolizumab (an immunotherapy), Binimetinib (a targeted therapy), and Bevacizumab (an angiogenesis inhibitor) on patients with advanced colorectal cancer that hasn't responded to previous treatments. It's an open-label phase II trial where all participants receive the same treatment.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs; high blood pressure; bleeding or clotting problems; fatigue; skin rash; liver enzyme changes; gastrointestinal symptoms like diarrhea and abdominal pain; increased risk of infections due to lowered immunity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time (measured in months) from each subject starting treatment until either death (from any cause) or being censored at their last contact.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time (measured in months) from each subject starting treatment until either death (from any cause) or being censored at their last contact.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response
Secondary study objectives
Adverse Events
Overall Survival (OS)
Progression-Free Survival (PFS)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Safety run-inExperimental Treatment3 Interventions
Ten patients will be accrued to stage 1 and treated with standard doses of pembrolizumab, binimetinib and bevacizumab. If the standard doses are not tolerable and 2 or more patients experience a DLT, then patients would be enrolled in dose level -1 which would comprise of standard doses of pembrolizumab and bevacizumab but binimetinib would be at a dose lower of 30 mg PO BID. If 2 or more patients experience a DLT at dose level -1, then patients will be enrolled in dose level -2 which will comprise of standard doses of pembrolizumab and bevacizumab but a lower dose of binimetinib at 15 mg BID. Upon determination of the safety and tolerability of the treatment regimen, the study will proceed to stage 2.
Group II: Cohort BExperimental Treatment3 Interventions
Patients will be treated with pembrolizumab, bevacizumab, and binimetinib together on day 1 of all cycles including cycle 1. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Group III: Cohort AExperimental Treatment3 Interventions
Patients will start with 7-day run-in of binimetinib on day -7 of cycle 1 only. Pembrolizumab and bevacizumab will then be added to binimetinib on cycle 1 day +1. Cycle 1 will end on day 21. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Bevacizumab
2013
Completed Phase 4
~5540
Binimetinib
2018
Completed Phase 3
~1200
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,555 Total Patients Enrolled
Christopher Lieu, MDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
109 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My colorectal cancer cannot be removed by surgery and has spread.My colorectal cancer has worsened after two treatments.I agree to use birth control or remain abstinent and not donate sperm for 6 months after treatment ends.My colorectal cancer cannot be removed by surgery and has spread.I am fully active or restricted in physically strenuous activity but can do light work.I have taken bevacizumab before.You must agree to have tissue samples taken before and after treatment. The doctor will make sure the procedure is safe for you.You are willing and able to follow the study's rules, according to the researcher's opinion.I am willing to have biopsies before and after treatment.I am 18 years old or older.I am 18 years old or older.My cancer can be measured by standard health scans.My previous use of bevacizumab does not affect my eligibility.My blood and organ tests are normal before starting the study drug.You cannot participate if you have a certain type of genetic marker called MSI-high or if you have a specific mutation in your BRAF gene. You also can't participate if you've had surgery or a major injury in the past 60 days, have untreated brain metastases, or have had radiation therapy within 14 days of the start of the study. Additionally, you can't take part if you've had certain types of cancer in the past 3 years, or if you have certain uncontrolled symptoms like pain or fluid buildup. Finally, you can't participate if you're currently taking any experimental or approved treatments.I do not have an autoimmune disease, nor have I needed treatment for one in the last 2 years.I do not have an active infection needing IV antibiotics, hepatitis B or C, HIV, and I follow flu shot guidelines.I do not have a history of eye diseases related to the retina.You cannot participate in the study if you have taken certain medications such as aspirin, clopidogrel, or anticoagulants recently, or had severe allergic reactions to certain types of drugs. You also cannot participate if you are allergic to specific components of Binimetinib, Pembrolizumab, or bevacizumab, or have received certain types of treatments in the past. Additionally, if you have a weakened immune system, or are taking medication to suppress your immune system, you are not eligible for the study.You can sign and date the consent form.My colorectal cancer has worsened after two treatments.I can carry out all my daily activities without help.Your white blood cell count should be between 2.5 and 15.0 billion cells per liter.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Safety run-in
- Group 3: Cohort B
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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