Replimune, Inc.
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 Inclusion Criteria: I 1. Male or female who is 12 years of age or older at the time of signed informed consent. I 2. Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma, as per AJCC staging system, 8th edition). I 3. Confirmed disease progression (PD) on an anti-PD-1 antibody treatment and an anti-CTLA-4 antibody treatment, administered as either a combination regimen (eg, nivolumab + ipilimumab) or in sequence. 1. Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks (…
Genetically modified Herpes Simplex Type 1 Virus.
Anti-PD-1 Monoclonal Antibody
Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody.
A programmed death receptor-1 (PD-1)-blocking antibody indicated.
Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.