A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

Recruiting Phase 2 Phase 3 Interventional Study
Metastatic Uveal Melanoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
280 (estimated)
Sponsor
Replimune, Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 i…
Contacts

Clinical Trials at Replimune

1-781-222-9570

Clinicaltrials@replimune.com

CONTACT

Giuseppe Gullo, MD

CONTACT