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
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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 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.
Locations
United States
Arizona
HonorHealth Research Insisute
RECRUITING
Scottsdale
California
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
The Angeles Clinic and Research Institute
RECRUITING
Los Angeles
University of California Los Angeles
RECRUITING
Los Angeles
Stanford Cancer Institute
RECRUITING
Palo Alto
Colorado
The Melanoma & Skin Cancer Institute
RECRUITING
Englewood
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Florida
Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Georgia
Emory Winship Cancer Institute
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
North Carolina
Duke University Medical Center
RECRUITING
Durham
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
The Ohio State University
RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
The West Clinic, PLLC dba West Cancer Center
RECRUITING
Germantown
Sarah Cannon Research Institute
RECRUITING
Nashville
Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic)
RECRUITING
Nashville
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
The University Of Texas Md Anderson Cancer Center
RECRUITING
Houston
Wisconsin
University Of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING
Madison
Contact Information
Primary
Clinical Trials at Replimune
Clinicaltrials@replimune.com
1-781-222-9570
Backup
Giuseppe Gullo, MD
Time Frame
Start Date:2024-12-17
Estimated Completion Date:2031-10
Participants
Target number of participants:280
Treatments
Experimental: Test Arm: RP2 + nivolumab
RP2 (Oncolytic virus) and Nivolumab (programmed death receptor-1 (PD-1) inhibitor)
Experimental: Control Arm (Active Comparator): ipilimumab + nivolumab