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ACTIVE NOT RECRUITING Phase 3

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

NCT05933577 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to learn if intismeran autogene 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 intismeran autogene with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

Conditions Studied

Interventions

  • BIOLOGICAL Pembrolizumab
  • OTHER Placebo
  • BIOLOGICAL Intismeran autogene

Study Locations (20)

Massachusetts

  • Massachusetts General Hospital ( Site 1927) — Boston
  • Beth Israel Deaconess Medical Center ( Site 1957) — Boston
  • Dana-Farber Cancer Institute ( Site 1956) — Boston

New Jersey

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944) — Hackensack
  • Atlantic Health System ( Site 1925) — Morristown
  • Valley Health Systems - Ridgewood Campus ( Site 1947) — Ridgewood

California

  • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918) — Los Angeles
  • UCSF Medical Center at Mission Bay ( Site 1929) — San Francisco

Florida

  • Orlando Health Cancer Institute ( Site 1937) — Orlando
  • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945) — Tampa

Georgia

  • Winship Cancer Institute of Emory University ( Site 1940) — Atlanta
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950) — Marietta

Michigan

  • University of Michigan ( Site 1915) — Ann Arbor
  • Cancer and Hematology Centers of Western Michigan ( Site 1932) — Grand Rapids

New York

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958) — Mineola
  • NYU Langone Health-Perlmutter Cancer Center ( Site 1917) — New York

Arkansas

  • Highlands Oncology Group ( Site 1943) — Springdale

Trial Details

FieldValue
Enrollment Target 1,089 participants
Start Date 2023-07-19
Est. Completion 2030-09-26
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05933577

The ClinicalTrials.gov registry entry for NCT05933577 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,089 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05933577 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Massachusetts, New Jersey, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05933577 about?

NCT05933577 is a clinical study titled "A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)". The purpose of this study is to learn if intismeran autogene 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 k...

What is the current status of trial NCT05933577?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,089 participants. The study started on 2023-07-19. Estimated completion is 2030-09-26.

What conditions does trial NCT05933577 study?

This clinical trial studies the following conditions: Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05933577?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), Intismeran autogene (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05933577?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05933577 being conducted?

This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial