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Checkpoint Inhibitor

VO + Nivolumab for Advanced Melanoma

Phase 3
Recruiting
Research Sponsored by Replimune Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has at least 1 measurable and injectable tumor of ≥1 cm in longest diameter (or shortest diameter for lymph nodes).
Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to january 2029, approximately 55 months
Awards & highlights

Summary

This trial is comparing a combination of VO and nivolumab to standard treatment for patients with advanced melanoma that has not responded to other treatments or who cannot receive certain other therapies.

Who is the study for?
This trial is for adults and children over 12 with advanced melanoma that worsened after treatment with anti-PD-1 and anti-CTLA-4 drugs, or those unsuitable for anti-CTLA-4 therapy. Participants must have at least one measurable tumor, proper organ function, and a documented BRAF V600 mutation status.
What is being tested?
The study compares VO (Vusolimogene Oderparepvec) combined with Nivolumab against treatments chosen by the patient's physician in cases of Stage IIIb to IV melanoma. It aims to find out if this combination is more effective than standard options after previous therapies fail.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, skin issues like rash or itching, liver inflammation (hepatitis), lung inflammation (pneumonitis), hormone gland problems (like thyroid disorders), and potential kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a tumor larger than 1 cm that can be measured and injected.
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My melanoma is at an advanced stage and cannot be surgically removed.
Select...
My cancer progressed after treatment with specific immunotherapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to january 2029, approximately 55 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to january 2029, approximately 55 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Secondary study objectives
Objective Response Rate (ORR)
Progression Free Survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VO + nivolumabExperimental Treatment2 Interventions
Group II: Physicians ChoiceActive Control4 Interventions
Choosing from 1 of the following (to be consistent with approved label and/or applicable local clinical guidelines): * Nivolumab + relatlimab (as Opdualag) * Anti-PD-1 monotherapy (nivolumab or pembrolizumab) * Single-agent chemotherapy (dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

Replimune Inc.Lead Sponsor
11 Previous Clinical Trials
1,215 Total Patients Enrolled
4 Trials studying Melanoma
710 Patients Enrolled for Melanoma
Giuseppe Gullo, MDStudy DirectorReplimune Inc.
~267 spots leftby Jan 2029
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