Recruiting NCT06581406
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RP2, Ipilimumab, Nivolumab.
- Who it may be relevant to
- Registry conditions: Metastatic Uveal Melanoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Biological RP2
Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation. - Biological Ipilimumab
Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody - Biological Nivolumab
Nivolumab: Anti-PD-1 Monoclonal antibody
Primary outcome measures
- Overall Survival (OS) [Time frame: From Day 1 up to 3 years after last dose.]
- Progression Free Survival (PFS) [Time frame: From Day 1 up to 3 years after last dose.]
Secondary outcome measures (3)
- Number of patients with treatment-emergent adverse events (TEAEs) [Time frame: From first dose up to 100 days after last dose.]
- Overall Response Rate (ORR) [Time frame: Every 12 weeks from Day 1 up to 3 years after last dose.]
- Disease Control Rate (DCR) [Time frame: Every 12 weeks from Day 1 up to 3 years after last dose.]
Eligibility criteria
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.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 29 centers
- HonorHealth Research Insisute — Scottsdale
- UC San Diego Moores Cancer Center — La Jolla
- The Angeles Clinic and Research Institute — Los Angeles
- University of California Los Angeles — Los Angeles
- Stanford Cancer Institute — Palo Alto
- University of Colorado Hospital - Anschutz Cancer Pavilion(ACP) — Aurora
- The Melanoma & Skin Cancer Institute — Englewood
- Georgetown University Medical Center — Washington D.C.
- … and 21 more centers
Australia · 2 centers
- Melanoma Institute Australia — Wollstonecraft
- Peter MacCallum Cancer Centre — Melbourne
United Kingdom · 2 centers
- The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool
- The Royal Marsden NHS Foundation Trust — London
Identifiers
NCT: NCT06581406 · RP2-202