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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
Must not have
Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Has known history of Hepatitis B or known active Hepatitis C virus infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 27 months
Awards & highlights
Summary
This trial is testing a new combination treatment for patients with advanced colorectal cancer. The treatment aims to boost the immune system's ability to fight cancer more effectively than current options.
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).
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a muscle disorder that causes high levels of creatine kinase.
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I have a history of Hepatitis B or an active Hepatitis C infection.
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I have received an organ or tissue transplant from another person.
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I have been treated for an autoimmune disease in the last 2 years.
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I have been treated with specific immune-targeting cancer drugs before.
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I have taken regorafenib or TAS-102 before.
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I have another cancer that is getting worse or was treated in the last 3 years.
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I have or had lung inflammation that needed steroids.
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I have cancer that has spread to my brain or spinal cord.
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I do not have an active infection needing treatment.
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I haven't had serious heart problems in the last year.
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My tumor is identified as having high microsatellite instability.
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I have had pancreatitis before.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS)
Secondary study objectives
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include immune checkpoint inhibitors like pembrolizumab (anti-PD-1) and favezelimab (anti-LAG-3), which work by blocking proteins that inhibit immune responses, thereby enhancing the body's ability to attack cancer cells. This is particularly important for colorectal cancer patients as it can lead to improved overall survival and response rates.
Other treatments include chemotherapy agents like regorafenib and TAS-102, which target cancer cell division and DNA synthesis, respectively. These mechanisms are vital as they offer multiple avenues to control and potentially reduce tumor growth.
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,840 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,965 Previous Clinical Trials
5,175,923 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,849 Previous Clinical Trials
8,080,375 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.
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