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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

No Placebo-Only Group

Pivotal Trial

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

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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.

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My cancer progressed after treatment with specific immunotherapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to january 2029, approximately 55 months

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

2015

Completed Phase 3

~4010

0 / 3Eligibility criteria met