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

Conditions

• Advanced Melanoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vusolimogene Oderparepvec — BIOLOGICAL
  Genetically modified Herpes Simplex Type 1 Virus.
• Nivolumab — BIOLOGICAL
  Anti-PD-1 Monoclonal Antibody
• Nivolumab + Relatlimab — BIOLOGICAL
  Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody.
• Pembrolizumab — BIOLOGICAL
  A programmed death receptor-1 (PD-1)-blocking antibody indicated.
• Single-agent chemotherapy — DRUG
  Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.

Study Details

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.

Key Dates

Start date

Jul 11, 2024

Status verified

May 2026

Primary completion

Jan 1, 2029

Completion

Aug 31, 2034

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: VO + nivolumab
• Active Comparator: Physicians Choice
  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)

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Assessed up to January 2029, approximately 55 months ]

Central Contacts

• Clinical Trials at Replimune
  1-781-222-9570
  [email protected]

Locations (50)

Find similar trials in Gilbert, AZ

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