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Back|NCT06581406Recruiting
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

Phase
Phase 2/Phase 3
Sponsor
Replimune Inc.
Enrollment
280
Timeline
Dec 2024 → Oct 2031
About This Study

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 Criteria

Inclusion Criteria

  • 1Patients who are 18 years of age or older at the time of signed informed consent.
  • 2Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.
  • 3Has 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.
  • 4Must be willing to provide tumor biopsy samples.
  • 5LDH ≤ 2 × upper limit of normal (ULN).
  • 6Has adequate hematologic, hepatic and renal function
  • 7Prothrombin 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.
  • 8Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • 9Life expectancy of \> 6 months as estimated by the Investigator.

Exclusion Criteria

  • 1Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.
  • 2Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
  • 3Current active significant herpetic infections or prior complications of HSV-1 infection.
  • 4Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis.
  • 5Major surgery ≤ 2 weeks prior to the first dose of study intervention.
  • 6Any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy.
  • 7Active, known, or suspected autoimmune disease requiring systemic treatment.
  • 8Prior treatment with an oncolytic virus.
  • 9Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
  • 10Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose.
  • 11Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose.
  • 12Conditions 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.

Locations

28 sites participating in this study

Emory Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Michael Lowe, MD

HonorHealth Research Insisute

Scottsdale, Arizona 85258

Recruiting

Justin Moser, MD

UC San Diego Moores Cancer Center

La Jolla, California 92037

Recruiting

Gregory Daniels, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →