A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma
Replimune, Inc.
Summary
The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Patients who are 18 years of age or older at the time of signed informed consent. * Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection. * Has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (≥ 1.5 cm in the shortest axis for a lymph node \[LN\]) that is amenable to serial RP2 injections. * Must be willing to provide tumor biopsy samples. * LDH ≤ 2 × upper limit of normal (ULN). * Has adequate hematologic, hepatic and renal function * Prothrombin time (PT) ≤ 1.5 × ULN (or international normalizati…
Interventions
- BiologicalRP2
Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
- BiologicalIpilimumab
Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
- BiologicalNivolumab
Nivolumab: Anti-PD-1 Monoclonal antibody
Locations (33)
- HonorHealth Research InsisuteScottsdale, Arizona
- UC San Diego Moores Cancer CenterLa Jolla, California
- The Angeles Clinic and Research InstituteLos Angeles, California
- University of California Los AngelesLos Angeles, California
- Stanford Cancer InstitutePalo Alto, California
- University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)Aurora, Colorado