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Pembrolizumab/Quavonlimab for Advanced Colorectal Cancer
Phase 2
Recruiting
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 a histologically confirmed diagnosis of Stage IV CRC adenocarcinoma (as defined by American Joint Committee on Cancer [AJCC] version 8)
Has locally confirmed dMMR/MSI-H
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 50 months
Awards & highlights
Study Summary
This trial will compare the effectiveness and safety of co-formulated pembrolizumab/quavonlimab with other treatments for people with MSI-H or dMMR metastatic stage IV colorectal cancer.
Who is the study for?
This trial is for adults with Stage IV colorectal cancer that's either MSI-H or dMMR. They should have measurable disease, adequate organ function, and a life expectancy of at least 3 months. Women must not be pregnant/breastfeeding and use effective contraception if of childbearing potential. Excluded are those with recent treatments/surgeries, live vaccines, other cancers within 2 years, CNS metastases, severe drug hypersensitivity, active infections like HIV/Hepatitis B/C, certain heart diseases or conditions that could affect study participation.Check my eligibility
What is being tested?
The trial tests the effectiveness and safety of a combined treatment (pembrolizumab/quavonlimab) against other therapies in patients with advanced colorectal cancer characterized by MSI-H/dMMR. It compares this combination to pembrolizumab alone or with favezelimab/vibostolimab/MK-4830 to see which works best.See study design
What are the potential side effects?
Potential side effects include allergic reactions to the drugs' components; immune-related issues such as inflammation in organs; increased risk of infections due to weakened immunity; fatigue; digestive problems; skin reactions; hormonal gland changes leading to hormone deficiencies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is Stage IV colon cancer.
Select...
My cancer is confirmed to have a specific genetic feature (dMMR/MSI-H).
Select...
I have Stage IV colon cancer that is MSI-H/dMMR and have not received any treatment.
Select...
My cancer can be measured by scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 50 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 50 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
DOR per RECIST 1.1 as assessed by Investigator
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
Number of Participants Discontinuing Study Treatment Due to an AE
+5 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab/VibostolimabExperimental Treatment1 Intervention
Participants receive co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
Group II: Pembrolizumab/QuavonlimabExperimental Treatment1 Intervention
Participants receive co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
Group III: Pembrolizumab/FavezelimabExperimental Treatment1 Intervention
Participants receive co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
Group IV: Pembrolizumab Plus MK-4830Experimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
Group V: PembrolizumabActive Control1 Intervention
Participants receive pembrolizumab 400 mg intravenously (IV) every 6 weeks (Q6W) for up to approximately 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab/Quavonlimab
2017
Completed Phase 2
~420
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,815 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,351 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,420 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide a recent (within 5 years) tumor sample that hasn't been exposed to radiation.I had radiotherapy less than 2 weeks before starting the study treatment.I have been treated with specific chemotherapy drugs for my condition.I am currently being treated for an active infection.I have had pancreatitis before.I have another cancer that is growing or was treated in the last 2 years.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have left-sided, RAS wild-type cancer and received EGFR therapy.I have a muscle disorder that causes high levels of creatine kinase.I have been treated for an autoimmune disease with medication in the last 2 years.I have fluid buildup needing drainage or medication in the last 2 weeks.My cancer progressed after standard treatments including specific chemotherapy drugs.I have cancer that has spread to my brain or spinal cord.I do not have severe heart problems or recent heart attacks.I have not received a live vaccine in the last 30 days.I am still recovering from a recent surgery or have complications from it.My condition is Stage IV colon cancer.I can provide a recent (within 5 years) tumor sample that hasn't been exposed to radiation.I have been diagnosed with HIV.My organs are functioning well.I am highly allergic to specific cancer drugs or their ingredients.My cancer is confirmed to have a specific genetic feature (dMMR/MSI-H).I have Stage IV colon cancer that is MSI-H/dMMR and have not received any treatment.I haven't had cancer treatment or been in a trial within the last 4 weeks.I have been treated with drugs targeting immune cells before.My cancer can be measured by scans.I am not pregnant, breastfeeding, and if able to bear children, I use effective birth control or practice abstinence.I have had pneumonitis treated with steroids or have it now.I have received an organ or tissue transplant from another person.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab Plus MK-4830
- Group 2: Pembrolizumab
- Group 3: Pembrolizumab/Quavonlimab
- Group 4: Pembrolizumab/Favezelimab
- Group 5: Pembrolizumab/Vibostolimab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any know adverse effects of Pembrolizumab/Quavonlimab?
"Pembrolizumab/Quavonlimab falls into the category of being a Phase 2 trial medication, which means while there is data supporting its safety, none backing up its efficacy. Consequently, our team at Power has given it a score of 2."
Answered by AI
How many people are currently participating in this trial?
"A total of 320 patients are required to partake in this clinical trial. These individuals must meet the pre-specified inclusion criteria. Patients have the opportunity to enroll at various locations, such as McGill University Health Centre-CIM - Oncology ( Site 0306) located in Montréal, Quebec and The University of Kansas Cancer Center - Westwood ( Site 1557) situated in Westwood, Kansas."
Answered by AI
Are other healthcare facilities in this state also participating in this experiment?
"Enrolment for this study is currently taking place at 11 sites, which are located in cities including Montréal, Westwood and Athens. If you wish to enroll, it may be most convenient to choose a location nearest you to minimize travel requirements."
Answered by AI
What is the most popular reason why patients are prescribed Pembrolizumab/Quavonlimab?
"Pembrolizumab/Quavonlimab can be used as an effective treatment against malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
Can patients still sign up for this research project?
"The clinicaltrials.gov website shows that this study is looking for volunteers right now. This trial was first announced on June 25th, 2021 and the most recent update was October 28th, 2022."
Answered by AI
What is the history of Pembrolizumab/Quavonlimab in medical research?
"City of Hope first studied pembrolizumab/quavonlimab in 2010 and there are now 250 completed studies. Out of the 1000 live trials, a large number are based out of Montréal, Quebec."
Answered by AI
Who else is applying?
What state do they live in?
Nova Scotia
How old are they?
18 - 65
What site did they apply to?
The Moncton Hospital-Oncology ( Site 0307)
What portion of applicants met pre-screening criteria?
Met criteria
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