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
NCT ID: NCT06581406
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
280 participants
INTERVENTIONAL
2024-12-17
2031-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 28-day Screening Period
* Treatment Period: Tumor measurements will be assessed every 12 weeks (Q12W)
* Safety Follow-Up - up to 100 days after the last dose of study drug.
* Efficacy Follow-Up,Tumor measurements by serial radiographic imaging Q12W
* Survival Follow-Up, survival information will be collected every 3 months for a minimum of 3 years
TREATMENT
NONE
Study Groups
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Test Arm: RP2 + nivolumab
RP2 (Oncolytic virus) and Nivolumab (programmed death receptor-1 (PD-1) inhibitor)
RP2
Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
Nivolumab
Nivolumab: Anti-PD-1 Monoclonal antibody
Control Arm (Active Comparator): ipilimumab + nivolumab
Immune Checkpoint inhibitor combination
Ipilimumab
Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
Nivolumab
Nivolumab: Anti-PD-1 Monoclonal antibody
Interventions
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RP2
Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
Ipilimumab
Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
Nivolumab
Nivolumab: Anti-PD-1 Monoclonal antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 normalization ratio \[INR\] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
* Life expectancy of \> 6 months as estimated by the Investigator.
Exclusion Criteria
* Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
* Current active significant herpetic infections or prior complications of HSV-1 infection.
* Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis.
* Major surgery ≤ 2 weeks prior to the first dose of study intervention.
* Any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy.
* Active, known, or suspected autoimmune disease requiring systemic treatment.
* Prior treatment with an oncolytic virus.
* Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
* Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose.
* Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose.
* Conditions requiring treatment with immunosuppressive doses (\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment.
ALL
No
Sponsors
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Replimune Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rahul Marpadga, MD MPH
Role: STUDY_DIRECTOR
Replimune Inc.
Locations
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HonorHealth Research Insisute
Scottsdale, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)
Aurora, Colorado, United States
The Melanoma & Skin Cancer Institute
Englewood, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic)
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
University Of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Countries
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Central Contacts
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Giuseppe Gullo, MD
Role: CONTACT
Facility Contacts
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Justin Moser, MD
Role: primary
Gregory Daniels, MD
Role: primary
Inderjit Mehmi, MD
Role: primary
Bartosz Chmielowski, MD
Role: primary
Allison Betof Warner, MD
Role: primary
Sapna Pradyuman Patel, MD
Role: primary
Ryan Weight, DO, MS
Role: primary
Suthee Rapisuwon, MD
Role: primary
Leonel Fernando Hernandez Aya, MD
Role: primary
Michael Lowe, MD
Role: primary
Sunandana Chandra, MD, MS
Role: primary
Daniel Olson, MD
Role: primary
Asad Javed, MD
Role: primary
Kamaneh Montazeri, MD
Role: primary
Alexander Shoushtari, MD
Role: primary
April Salama, MD
Role: primary
Richard Wu, MD, PhD
Role: primary
Marlana Orloff, MD
Role: primary
Diwakar Davar, MD
Role: primary
Arnel M. Pallera, MD
Role: primary
Meredith Ann McKean, MD, MPH
Role: primary
Douglas B. Johnson, MD
Role: primary
Sanjay Chandrasekaran, MD
Role: primary
Alexandra Ikeguchi, MD
Role: primary
Vincent Ma, MD
Role: primary
Other Identifiers
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RP2-202
Identifier Type: -
Identifier Source: org_study_id