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Checkpoint Inhibitor

V940 Vaccine + Pembrolizumab for Melanoma

Q: What is the current enrollment for this trial?

<p>Merck Sharp &#x26; Dohme LLC is responsible for the organization and execution of this trial, which requires a total 1089 participants matching its eligibility criteria. The investigation will be conducted in two sites: Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo located in Montréal and Centre intégré de cancérologie du CHU de Québec Université L-Hemato-<a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> (Site 1101) situated in Quebec City's M. De Santiago region.</p>

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 85 months

Awards & highlights

Study Summary

This trial studies if a customized cancer vaccine plus a drug can prevent cancer from coming back in high-risk melanoma patients.

Who is the study for?

This trial is for individuals with high-risk melanoma who have had surgery but no other systemic therapy. Participants must be disease-free post-surgery, not more than 13 weeks from their last resection, and if HIV-positive, well-controlled on ART. It excludes those with ocular/mucosal melanoma, active heart failure within 6 months, prior cancer therapies or vaccines, another recent or active spreadable cancer.Check my eligibility

What is being tested?

The study tests V940 (an individualized neoantigen therapy) combined with pembrolizumab against pembrolizumab alone to see which is better at preventing the return of melanoma after surgical removal. The safety of this combination and its effectiveness in keeping patients cancer-free are being evaluated.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fatigue, skin issues, flu-like symptoms and possible organ inflammation due to pembrolizumab; specific side effects of V940 are not detailed but may involve similar immune-related responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 85 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 85 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 85 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence-Free Survival (RFS)

Secondary outcome measures

Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: V940 + PembrolizumabExperimental Treatment2 Interventions

Participants receive up to 9 doses of V940 via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.

Group II: Placebo + PembrolizumabActive Control2 Interventions

Participants receive up to 9 doses of dose matched placebo to V940 via an IM injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,057 Total Patients Enrolled

120 Trials studying Melanoma

20,594 Patients Enrolled for Melanoma

ModernaTX, Inc.Industry Sponsor

108 Previous Clinical Trials

61,378,228 Total Patients Enrolled

1 Trials studying Melanoma

257 Patients Enrolled for Melanoma

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,315 Total Patients Enrolled

35 Trials studying Melanoma

10,215 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of V940 and Pembrolizumab received endorsement from the Food & Drug Administration?

"V940 in conjunction with Pembrolizumab garnered a score of 3 due to its existing clinical data which supports both efficacy and safety."

Answered by AI

What is the scope of medical practices currently participating in this clinical trial?

"Currently, 12 different medical centres are participating in this clinical trial. This includes facilities located in Montréal, Quebec City and Santiago as well as other locations across the globe. To reduce any travel burden associated with participation, it is best for patients to select a clinic closest to their residence."

Answered by AI

Are there still openings for volunteers to partake in this trial?

"Confirmative. Clinicaltrials.gov reports that this medical project, initially posted on July 19th 2023, is currently recruiting potential patients. A total of 1089 participants need to be recruited at a dozen different sites."

Answered by AI

What is the current enrollment for this trial?

"Merck Sharp & Dohme LLC is responsible for the organization and execution of this trial, which requires a total 1089 participants matching its eligibility criteria. The investigation will be conducted in two sites: Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo located in Montréal and Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology (Site 1101) situated in Quebec City's M. De Santiago region."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

2023. "A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05933577.

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