Vusolimogene Oderparepvec in combination with Nivolumab vs Physician's Choice in Advanced Melanoma
Research type
Research Study
Full title
A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician’s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]
IRAS ID
1011536
Contact name
Kari Jeschke
Contact email
Sponsor organisation
Replimune Limited
Clinicaltrials.gov Identifier
Research summary
Advanced melanoma is a form of cancer that can spread unpredictably to almost any organ. Common areas include
the skin, lungs, brain & liver. Current treatments available for advanced melanoma have improved survival and slowed disease
progression, however only about half of patients respond to initial treatment, highlighting a significant unmet need to discover novel
therapies. Nivolumab is a therapeutic treatment approved for advanced melanoma. The purpose of this study is to determine if the
study medication, vusolimogene oderparepvec (VO) in combination with nivolumab is more effective against standard of care (SoC)
medications currently available for patients with advanced melanoma. Persons who are 12 years of age or older with advanced
melanoma and wish to participate in the study, will have a series of evaluations to determine if they are eligible to enrol and receive
medication. Persons who are eligible to enrol in the study, will be randomly assigned to receive either the study medication, VO and
nivolumab, or 1 of the following SoC treatments: nivolumab alone, pembrolizumab, nivolumab with relatlimab or a chemotherapy
agent. Participants assigned in the VO and nivolumab group will at first receive VO alone, this will be done via injection into
injectable tumours. Dosing with nivolumab will begin with the second dose of VO via intravenous (IV) infusion. Participants assigned
to the SoC treatment group will receive an IV infusion of the treatment. During treatment, participantd will have assessments
regularly performed such as physical exams, blood sampling, tumour assessments & quality of life questionnaires. If a participant
discontinues from the medication, they are encouraged to continue to have visits & contact with their study doctor to monitor their
health. This study is being funded by Replimune, Inc & will be conducted at 120 sites globally. This study will be overseen by an
independent data monitoring committee to monitor safety.REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0300
Date of REC Opinion
2 Jul 2025
REC opinion
Further Information Favourable Opinion