RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-07-11

Study Completion:2034-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06264180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Clinical Trials at Replimune

CONTACT

1-781-222-9570

clinicaltrials@replimune.com

Principal Investigator

Giuseppe Gullo, MD

STUDY_DIRECTOR

Replimune Inc.

Study Locations (Sites)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143

United States

University of Iowa

Iowa City, Iowa, 52242

United States

University of Louisville Brown Cancer Center

Louisville, Kentucky, 40202

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Morristown Medical Center - Atlantic Health System

Morristown, New Jersey, 07960

United States

Stony Brook University Cancer Center

Stony Brook, New York, 11794

United States

Duke Cancer Center

Durham, North Carolina, 27710

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

UPMC

Pittsburgh, Pennsylvania, 15232

United States

West Cancer Center and Research Institute

Germantown, Tennessee, 38138

United States

University of Tennessee

Knoxville, Tennessee, 37920

United States

Intermountain Health

Murray, Utah, 84107

United States

Collaborators and Investigators

Sponsor: Replimune Inc.

Giuseppe Gullo, MD, STUDY_DIRECTOR, Replimune Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-11

Study Completion Date2034-08-31

Study Record Updates

Study Start Date2024-07-11

Study Completion Date2034-08-31

Terms related to this study

Additional Relevant MeSH Terms

Advanced Melanoma