RecruitingPhase 3NCT06264180

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]

Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment [IGNYTE-3]


Sponsor

Replimune, Inc.

Enrollment

400 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — vusolimogene oderparepvec (VO, a virus-based cancer therapy injected into tumors) and nivolumab (an immunotherapy drug) — in patients with advanced melanoma whose cancer stopped responding to standard immunotherapy. **You may be eligible if...** - You are 12 years of age or older - You have advanced melanoma (unresectable or metastatic, Stage IIIb-IV) - Your cancer progressed after receiving both anti-PD-1 therapy (e.g., nivolumab or pembrolizumab) and anti-CTLA-4 therapy (e.g., ipilimumab), either together or in sequence - You have injectable tumors accessible for direct injection **You may NOT be eligible if...** - You have active autoimmune disease requiring treatment - You have active brain metastases - You have certain serious infections or significant organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVusolimogene Oderparepvec

Genetically modified Herpes Simplex Type 1 Virus.

BIOLOGICALNivolumab

Anti-PD-1 Monoclonal Antibody

BIOLOGICALNivolumab + Relatlimab

Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody.

BIOLOGICALPembrolizumab

A programmed death receptor-1 (PD-1)-blocking antibody indicated.

DRUGSingle-agent chemotherapy

Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.


Locations(73)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, United States

UC Irvine Health, Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Sutter Medical Group

Sacramento, California, United States

San Francisco Oncology Associates

San Francisco, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, United States

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

University of Louisville Brown Cancer Center

Louisville, Kentucky, United States

Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Dartmouth Hitchcock Cancer Center

Lebanon, New Hampshire, United States

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Morristown Medical Center - Atlantic Health System

Morristown, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Northwell Health, R.J. Zuckerberg Cancer Center

Lake Success, New York, United States

Stony Brook University Cancer Center

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke Cancer Center

Durham, North Carolina, United States

The Ohio State University- Martha Morehouse Tower

Columbus, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

West Cancer Center and Research Institute

Germantown, Tennessee, United States

University of Tennessee

Knoxville, Tennessee, United States

Texas Oncology

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Intermountain Health

Murray, Utah, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

St. George Regional Hospital

St. George, Utah, United States

University of Vermont Medical Center

Burlington, Vermont, United States

West Virginia University

Morgantown, West Virginia, United States

CHU de Lille

Lille, France

Hopital de La Timone

Marseille, France

CHU Nice

Nice, France

Hôpital Saint Louis - AP-HP

Paris, France

Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Institut Gustave Roussy

Villejuif, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Helios Klinik

Erfurt, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Medical Center

Hamburg, Germany

Universitätsklinikum Hospital Heidelberg

Heidelberg, Germany

University of Kiel

Kiel, Germany

Universitatsklinikum Mainz Hautklinik und Poliklinik

Mainz, Germany

Universitätsklinikum of Tübingen

Tübingen, Germany

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

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NCT06264180


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