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
- Conditions
- Metastatic Uveal Melanoma
- Interventions
- Registration Number
- NCT06581406
- Lead Sponsor
- Replimune Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 280
- 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.
Key
- Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.
- 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.
Additional inclusion/ exclusion criteria are outlined in the study protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Arm: RP2 + nivolumab RP2 RP2 (Oncolytic virus) and Nivolumab (programmed death receptor-1 (PD-1) inhibitor) Control Arm (Active Comparator): ipilimumab + nivolumab Ipilimumab Immune Checkpoint inhibitor combination Test Arm: RP2 + nivolumab Nivolumab RP2 (Oncolytic virus) and Nivolumab (programmed death receptor-1 (PD-1) inhibitor) Control Arm (Active Comparator): ipilimumab + nivolumab Nivolumab Immune Checkpoint inhibitor combination
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From Day 1 up to 3 years after last dose. OS is the time from the date of randomization to death from any cause.
Progression Free Survival (PFS) From Day 1 up to 3 years after last dose. PFS is the time from randomization to first evidence of confirmed disease progression as assessed by BICR per RECIST 1.1 or death from any cause.
- Secondary Outcome Measures
Name Time Method Number of patients with treatment-emergent adverse events (TEAEs) From first dose up to 100 days after last dose. The incidence of all TEAEs.
Overall Response Rate (ORR) Every 12 weeks from Day 1 up to 3 years after last dose. ORR is the proportion of patients with a confirmed best overall response of complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1.
Disease Control Rate (DCR) Every 12 weeks from Day 1 up to 3 years after last dose. DCR is the proportion of patients with a confirmed best overall response of CR, PR, or Stable Disease (SD), as assessed by BICR per RECIST 1.1.
Related Research Topics
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Trial Locations
- Locations (15)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University Of Wisconsin Carbone Cancer Center - University Hospital
🇺🇸Madison, Wisconsin, United States
The West Clinic, PLLC dba West Cancer Center
🇺🇸Germantown, Tennessee, United States
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
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States
Emory Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
The University Of Texas Md Anderson Cancer Center
🇺🇸Houston, Texas, United States