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NCT06264180 | RECRUITING | Advanced Melanoma

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

Replimune Inc.

Brief 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.

Condition or disease

Advanced Melanoma

Intervention/treatment

Vusolimogene Oderparepvec

Nivolumab

Nivolumab + Relatlimab

Pembrolizumab

Single-agent chemotherapy

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-07-11
Estimated Primary Completion Date : 2029-01-01
Estimated Study Completion Date : 2034-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • * Male or female who is 12 years of age or older at the time of signed informed consent.
  • * Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma.
  • * Confirmed disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab) or in sequence.
  • 1. Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks
  • 2. Patients who in the physician's judgement are not candidates for treatment with an anti-CTLA-4 antibody are eligible
  • * Has documented BRAF V600 mutation status. Patients with BRAF mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to enrollment in the study, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition or prior toxicity.
  • * Has at least 1 measurable and injectable tumor of ≥1 cm in longest diameter (or shortest diameter for lymph nodes).
  • * Has adequate hematologic function.
  • * Has adequate hepatic function.
  • * Has adequate renal function.
  • * Prothrombin time (PT) ≤1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN
  • * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1 for patients 18 years and older or a Lansky performance score (PSc) ≥80 for patients 12 to 17 years of age.
  • * Life expectancy of at least 3 months.
  • * Female and male patients of reproductive potential must agree to avoid becoming pregnant or impregnating a partner and adhere to highly effective contraception requirements during the treatment period and for at least 6 months after the last dose of study treatment.
  • * Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test within 72 hours before the first dose of study treatment.
  • Key Exclusion Criteria
    • * Primary mucosal or uveal melanoma.
    • * More than 2 lines of systemic therapy for advanced melanoma.
    • * Known acute or chronic hepatitis.
    • * Known human immunodeficiency virus (HIV) infection.
    • * Active significant herpetic infections or prior complications of HSV-1 infection.
    • * Had systemic infection requiring IV antibiotics or other serious active infection requiring antimicrobial, antiviral, or antifungal treatment within 14 days prior to dosing.
    • * With active significant herpetic infections or prior complications of HSV-1 infection.
    • * Evidence of spinal cord compression or at high risk of spinal cord compression.
    • * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis at time of screening.
    • * Serum lactate dehydrogenase (LDH) \>2 × ULN.
    • * Major surgery ≤2 weeks prior to starting study drug.
    • * Prior malignancy active within the previous 3 years, except for locally curable cancers that have apparently been cured
    • * History of significant cardiac disease including myocarditis or congestive heart.
    • * History of life-threatening toxicity related to prior immune.
    • * Active, known, or suspected autoimmune disease requiring systemic treatment.
    • * History of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
    • * Prior oncolytic virus or other therapy given by intratumoral administration.
    • * Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
    • * Has received a live vaccine within 28 days prior to the first dose of study treatment.
    • * Systemic anticancer therapies within 5 half-lives or 4 weeks of the first dose, whichever is shorter.
    • * Conditions requiring treatment with immunosuppressive doses (\>10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment.
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)

Location Details

NCT06264180

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

UC San Diego Moores Cancer Center

THE JOLLA, California, United States, 92037

RECRUITING

United States, California

The Angeles Clinic and Research Institute

Los Angeles, California, United States, 90025

RECRUITING

United States, California

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

RECRUITING

United States, California

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, United States, 90095

RECRUITING

United States, California

UC Irvine Health, Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868

RECRUITING

United States, California

Stanford Cancer Institute

Palo Alto, California, United States, 94304

RECRUITING

United States, California

San Francisco Oncology Associates

San Francisco, California, United States, 94115

RECRUITING

United States, California

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States, 94143

RECRUITING

United States, District of Columbia

MedStar Washington Hospital Center

Washington, District of Columbia, United States, 20010

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Georgia

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Illinois

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States, 60068

RECRUITING

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Kansas

University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

RECRUITING

United States, Kentucky

University of Louisville Brown Cancer Center

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Minnesota

The University of Minnesota

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, New Jersey

MD Anderson Cancer Center at Cooper

Cam, New Jersey, United States, 08103

RECRUITING

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

RECRUITING

United States, New Jersey

Morristown Medical Center - Atlantic Health System

Morristown, New Jersey, United States, 07960

RECRUITING

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10461

RECRUITING

United States, New York

Stony Brook University Cancer Center

Stony Brook, New York, United States, 11794

RECRUITING

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

RECRUITING

United States, North Carolina

Duke Cancer Center

Durham, North Carolina, United States, 27710

RECRUITING

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Pennsylvania

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

RECRUITING

United States, Pennsylvania

UPMC

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, Tennessee

West Cancer Center and Research Institute

Germantown, Tennessee, United States, 38138

RECRUITING

United States, Tennessee

University of Tennessee

Knoxville, Tennessee, United States, 37920

RECRUITING

United States, Texas

Texas Oncology

Dallas, Texas, United States, 75246

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

RECRUITING

United States, Utah

Intermountain Health

Murray, Utah, United States, 84107

RECRUITING

United States, Utah

St. George Regional Hospital

Saint George, Utah, United States, 84790

RECRUITING

United States, West Virginia

West Virginia University

Morgantown, West Virginia, United States, 26506