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Monoclonal Antibodies
MK-4280A for Colorectal Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.
Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 27 months
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of a new two-drug combo (MK-4280A) to the current standard of care for metastatic colorectal cancer. The hypothesis is that MK-4280A will help people live longer.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that's PD-L1 positive and has worsened after standard treatment. They must be able to take oral meds, have a life expectancy of at least 3 months, and an ECOG score of 0-1 (which means they are fully active or restricted in physically strenuous activity but can do light work).Check my eligibility
What is being tested?
The study tests MK-4280A, a combo of favezelimab/pembrolizumab, against the usual treatments regorafenib and TAS-102. The goal is to see if MK-4280A helps patients live longer compared to the standard care.See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, digestive issues such as nausea or diarrhea, skin reactions, hormonal gland problems (like thyroid dysfunction), and potential increase in infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My colorectal cancer has spread and cannot be surgically removed.
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I can swallow pills and don't have major stomach issues affecting medicine absorption.
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I can provide a recent (within 5 years) tumor sample that hasn't been exposed to radiation.
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I can swallow pills and don't have major stomach issues affecting medicine absorption.
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My condition worsened after standard treatment or I couldn't tolerate it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Favezelimab/PembrolizumabExperimental Treatment1 Intervention
Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.
Group II: Standard of Care (Regorafenib or TAS-102)Active Control2 Interventions
At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.
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Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,851 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,542 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,432 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had cancer treatment or been in a cancer study in the last 4 weeks.I have a muscle disorder that causes high levels of creatine kinase.I have a history of Hepatitis B or an active Hepatitis C infection.My organs are functioning well.I haven't had serious heart problems in the last year.I have received an organ or tissue transplant from another person.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant as confirmed by a recent test.I have been treated for an autoimmune disease in the last 2 years.I have been treated with specific immune-targeting cancer drugs before.I have taken regorafenib or TAS-102 before.I have another cancer that is getting worse or was treated in the last 3 years.I have or had lung inflammation that needed steroids.I have cancer that has spread to my brain or spinal cord.I do not have an active infection needing treatment.The patient has a measurable disease according to the RECIST 1.1 guidelines as assessed by the local site investigator.My colorectal cancer has spread and cannot be surgically removed.The life expectancy of this tumor is at least 3 months, according to the investigator's assessment.My tumor is identified as having high microsatellite instability.I can swallow pills and don't have major stomach issues affecting medicine absorption.I can provide a recent (within 5 years) tumor sample that hasn't been treated with radiation.I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well.I can provide a recent (within 5 years) tumor sample that hasn't been exposed to radiation.I can swallow pills and don't have major stomach issues affecting medicine absorption.I have not received a live vaccine in the last 30 days.You have had a serious allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I had radiotherapy over 2 weeks ago, have no side effects, and don't need steroids.I have had pancreatitis before.My condition worsened after standard treatment or I couldn't tolerate it.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (Regorafenib or TAS-102)
- Group 2: Favezelimab/Pembrolizumab
Awards:
This trial has 2 awards, including:- 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.
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.
Could you please share how many hospitals are participating in this trial?
"There are 18 sites in total enrolling patients for this clinical trial, including Memorial Sloan Kettering Cancer Center (Site 1703) in New york, New York, Sibley Memorial Hospital (Site 1143) in Washington, District of Columbia, and Georgetown University Hospital (Site 1148) in Marietta, Georgia."
Answered by AI
What is the primary therapeutic use for favezelimab/pembrolizumab?
"favezelimab/pembrolizumab, while most often used to treat malignant neoplasms, can also be an effective course of treatment for unresectable melanoma, microsatellite instability high, and high risk of recurrence."
Answered by AI
Are there any current openings for subjects in this trial?
"The clinical trial in question was posted on November 10th, 2021 and was last edited on October 12th, 2022. This study is no longer recruiting patients, however there are 2193 other trials that are currently looking for participants."
Answered by AI
Are there any other examples in the medical literature of favezelimab/pembrolizumab?
"There are currently 1093 clinical trials researching favezelimab/pembrolizumab. Of those, 130 are in Phase 3. Most of the trials for this treatment are based in Malaga, California, but there are 36979 locations running studies."
Answered by AI
Could you please elucidate on the potential dangers of favezelimab/pembrolizumab?
"There is both efficacy and safety data from Phase 3 trials, so favezelimab/pembrolizumab was given a safety score of 3."
Answered by AI
How many patients are needed for this research project?
"This research is not admitting patients to the trial at this time. The study was first made available on November 10th, 2021 and was last updated on October 12th, 2022. If you are interested in other studies, there are currently 1100 trials actively recruiting patients with colorectal carcinoma and 1093 studies for favezelimab/pembrolizumab looking for participants."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
Oregon Health & Science University ( Site 1141)
VCU Health Adult Outpatient Pavillion ( Site 1712)
MUSC Hollings Cancer Center ( Site 1715)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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