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Checkpoint Inhibitor
Pembrolizumab/Vibostolimab for Blood Cancers
Phase 2
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
For PMBCL, DLBCL, FL, and MM: Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it.
For PMBCL, DLBCL, FL, and MM: - Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose at cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). cycle = 3 weeks
Awards & highlights
Study Summary
This trial will test a new cancer treatment, made of two drugs, to see if it is safe and works well against hematological malignancies.
Who is the study for?
This trial is for adults with certain blood cancers that have come back or haven't responded to treatment. They must have tried standard treatments, be ineligible or intolerant to them, and not pregnant or breastfeeding. Participants need functioning organs and can't join if they've had recent major surgery, live vaccines, other clinical trials within 4 weeks, severe allergies to the drugs tested, active infections needing systemic therapy, HIV/AIDS, uncontrolled diseases or conditions.Check my eligibility
What is being tested?
The study tests a combination drug called pembrolizumab/vibostolimab (MK-7684A) on various relapsed/refractory hematological malignancies. It aims to assess safety and tolerability as well as how well it works (response rate), how long it works (duration of response), disease control rate and its pharmacokinetics—how the body absorbs and processes the drug.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for cancer immunotherapy like pembrolizumab include fatigue, skin reactions at injection site, itching rash all over body; flu-like symptoms including fever chills muscle joint pain; nausea vomiting diarrhea constipation loss of appetite weight changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer did not respond or came back after CAR-T-cell therapy, or I can't receive this therapy.
Select...
My cancer did not respond to or I can't have CAR-T-cell therapy.
Select...
I can provide a recent bone marrow sample for testing.
Select...
I have Mantle cell lymphoma and have been treated with a Bruton's tyrosine kinase inhibitor.
Select...
My cancer is a type of lymphoma or multiple myeloma that has returned or did not respond to treatment.
Select...
My cancer is a type of lymphoma or multiple myeloma that has returned or did not respond to treatment.
Select...
I have Mantle cell lymphoma and have been treated with a specific type of cancer therapy before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose at cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). cycle = 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose at cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). cycle = 3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Discontinued Study Treatment Due to an AE
Number of Participants Who Experienced an Adverse Event (AE)
Number of Participants with a Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Lowest Plasma Concentration (Ctrough) of Vibostolimab
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab/vibostolimab coformulationExperimental Treatment1 Intervention
Participants will receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
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Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,648 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,373 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,306 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have fully recovered from any major surgery before starting the study.I have a known history of HIV.I had radiotherapy less than 2 weeks before starting the study.I have not received a live vaccine in the last 30 days.I have had serious heart problems in the last year.I need urgent treatment to reduce my PMBCL tumor size.I have an autoimmune disease treated with medication in the last 2 years.My cancer did not respond or came back after CAR-T-cell therapy, or I can't receive this therapy.I am not pregnant or breastfeeding and either can't have children or use effective birth control.My condition is a specific type of blood cancer.I have a history of specific blood disorders related to my multiple myeloma.I can provide a recent bone marrow sample for testing.I have DLBCL or NHL and cannot undergo standard treatments anymore.I am currently being treated for an infection.I have had a stem cell or organ transplant in the last 5 years.My cancer did not respond to or I can't have CAR-T-cell therapy.I have Mantle cell lymphoma and have been treated with a Bruton's tyrosine kinase inhibitor.I have a specific type of blood cancer that is not common DLBCL or NHL.My organs are functioning well.I have both active hepatitis B and C infections.My cancer is a type of lymphoma or multiple myeloma that has returned or did not respond to treatment.My cancer is a type of lymphoma or multiple myeloma that has returned or did not respond to treatment.I am HBsAg positive but have been on HBV therapy for 4 weeks with an undetectable viral load.I need treatment for fluid buildup in my chest or abdomen recently.I have DLBCL or NHL and cannot undergo standard treatments anymore.I have had another type of cancer in the past.I have Mantle cell lymphoma and have been treated with a specific type of cancer therapy before.My multiple myeloma has affected my brain or spinal cord.My EBV-positive lymphoma is linked to an organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab/vibostolimab coformulation
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.
Can you tell me how many different locations this trial is taking place?
"There are a total of 13 locations currently recruiting patients for this clinical trial, these include University of Chicago Medical Center (Site 0005) in Chicago, Jewish General Hospital (Site 0032) in Montreal and University of Texas MD Anderson Cancer Center ( Site 0014) in Houston."
Answered by AI
What are the goals of this particular clinical trial?
"The purpose of this trial, which will last for up to 6 weeks, is to document the number of adverse events experienced by participants. Additionally, researchers will be looking at disease control rate (DCR) and duration of response (DOR) as secondary outcomes. Finally, they hope to gain insights into the maximum concentration (Cmax) of Vibostolimab in plasma."
Answered by AI
What are the dangers that come with taking Pembrolizumab/vibostolimab coformulation?
"Pembrolizumab/vibostolimab coformulation is classified as a Phase 2 drug, so there is some data supporting its safety. However, because this trial lacks evidence of efficacy, it received a score of 2."
Answered by AI
How many people have been chosen to participate in this clinical trial?
"One hundred and eighty individuals that meet the pre-specified inclusion criteria are required for this study. These potential participants can be recruited from different hospitals, such as University of Chicago Medical Center in Illinois or Jewish General Hospital in Montreal, Quebec."
Answered by AI
Are there any patients currently being recruited for this study?
"Yes, as of today this clinical trial is still looking for participants. According to the information on clinicaltrials.gov, the study was first posted on September 28th, 2021 and has since been updated on November 17th, 2022."
Answered by AI
Are there other examples in the medical literature of Pembrolizumab and vibostolimab being used together?
"City of Hope first studied the pembrolizumab/vibostolimab coformulation in 2010 and there are now 247 completed studies. At present, 1000 clinical trials are still active; many of these taking place in Chicago, Illinois."
Answered by AI
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