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

Study Purpose

The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma.

- Has not received any prior systemic therapy for their melanoma beyond surgical resection.

- No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab.

- Is disease free at the time of providing documented consent for the study.

- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following: - Has ocular or mucosal melanoma.

- Has cancer that has spread to other parts of the body and cannot be removed with surgery.

- Has heart failure within the past 6 months.

- Has received prior cancer therapy or another cancer vaccine.

- Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years.

- Has severe reaction to study medications or any of their substance used to prepare a drug.

- Have not recovered from major surgery or have ongoing surgical complications

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05933577
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Merck Sharp & Dohme LLC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Director
Principal Investigator Affiliation	Merck Sharp & Dohme LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Greece, Israel, Italy, New Zealand, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: V940 + Pembrolizumab

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.

Active Comparator: Placebo + Pembrolizumab

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.

Interventions

Biological: - V940

IM injection

Biological: - Pembrolizumab

IV infusion

Other: - Placebo

IM injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Highlands Oncology Group ( Site 1943), Springdale, Arkansas

Status

Recruiting

Address

Highlands Oncology Group ( Site 1943)

Springdale, Arkansas, 72762

Site Contact

Study Coordinator

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