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 · NCT06581406 · Interventional (participants receive a specific treatment) · Lead sponsor: Replimune, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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 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
Exclusion criteria
- 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
Where it is running
33 locations listed across 18 US 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
- 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
- Mayo Clinic - Jacksonville FL - Jacksonville, Florida, 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
- Mayo Clinic Rochester - Rochester, Minnesota, 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
- University of Tennessee Medical Center - Knoxville, 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
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- University Of Wisconsin Carbone Cancer Center - University Hospital - Madison, Wisconsin, United States
- The Royal Marsden NHS Foundation Trust - London, United Kingdom
- The Clatterbridge Cancer Centre NHS Foundation Trust - Liverpool, Merseyside, United Kingdom
- Melanoma Institute Australia - Wollstonecraft, New South Wales, Australia
- Peter MacCallum Cancer Centre - Melbourne, Victoria, Australia