Checkpoint Inhibitor

Pembrolizumab/vibostolimab coformuation for Blood Cancers

Universitaetsklinikum Essen ( Site 0327), Essen, Germany

Pembrolizumab/vibostolimab coformuationPhase 2Waitlist AvailableResearch Sponsored by Merck Sharp & Dohme LLC

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.

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Uppredose at cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). cycle = 3 weeks

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Blood Cancers

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

If you have PMBCL, DLBCL, FL, or MM, you must have already tried CAR-T-cell therapy and it didn't work, or you can't receive it.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose at cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). cycle = 3 weeks for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,794 Previous Clinical Trials

5,001,826 Total Patients Enrolled

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,577,865 Total Patients Enrolled

Medical DirectorStudy Director

Merck Sharp & Dohme LLC

2,710 Previous Clinical Trials

7,992,223 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05005442 — Phase 2

Blood Cancers Research Study Groups: Pembrolizumab/vibostolimab coformulation

Blood Cancers Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05005442 — Phase 2

Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05005442 — Phase 2

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 maladies that Pembrolizumab/vibostolimab coformulation is used for?

"Pembrolizumab/vibostolimab is most often used to fight cancer. However, it can also be used to treat other health complications like unresectable melanoma and microsatellite instability high."

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

Recent research and studies

clinicaltrials.govStudy

A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)

2021. "A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05005442.