West Cancer Center

UVEAL MELANOMA: METASTATIC: 1st line: RP2-202: REVEAL

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

Title

Replimune RP2-202 Uveal melanom

Study Title

Site Link

NCT06581406

Malignancy

Uveal melanoma, Ocular melanoma, Eye melanoma

Stage

Stage 4

Disease Setting

Metastatic/Unresectable

Line Of Therapy

1st Line

Investigational Agent

RP2

Drug Class

Oncolytic immunotherapy

Arnel Pallera

Sponsor

Replimune

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Confirmed metastatic uveal melanoma not amenable to surgical resection
At least 1 measurable and injectable tumor of > or = 1 cm in longest diameter (1.5 cm in short axis for a lymph node)
LDH <2x ULH
ECOG PS 0-1
No prior exposure to PD-1 agents
No known HBV/HCV/HIV
No CNS involvement

Objective

Primary
- OS
- PFS
Secondary
- AE
- ORR
- DCR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Uveal melanoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes