Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Paclitaxel

Pembrolizumab

Temozolomide

Albumin-Bound Paclitaxel

Nivolumab

Relatlimab

Immunoglobulins

Dacarbazine

Antibodies, Blocking

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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)

Genetically modified Herpes Simplex Type 1 Virus.

Vusolimogene Oderparepvec

Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody.

Nivolumab + Relatlimab

A programmed death receptor-1 (PD-1)-blocking antibody indicated.

Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.

Single-agent chemotherapy

Clinical Trials at Replimune

Giuseppe Gullo, MD

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.

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

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

Time from the date of randomization to death due to any cause

The time from the date of randomization to the earliest date of the objective documentation of progressive disease (PD) per RECIST v1.1 or death due to any cause.

The proportion of randomized patients with best overall response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria.

Replimune Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)	NCT06264180	Advanced Melano...	Vusolimogene Od... Nivolumab Nivolumab + Rel... Pembrolizumab Single-agent ch...	12 Years -	Replimune Inc.
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)	NCT06264180	Advanced Melano...	Vusolimogene Od... Nivolumab Nivolumab + Rel... Pembrolizumab Single-agent ch...	12 Years -	Replimune Inc.

Spots Global Cancer Trial Database for vusolimogene oderparepvec