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

Launched by REPLIMUNE INC. · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness and safety of a new treatment combination for patients with metastatic uveal melanoma, a type of eye cancer that has spread to other parts of the body. Researchers are comparing the effects of two treatments: RP2 in combination with nivolumab versus nivolumab combined with ipilimumab. This study is specifically for adults who have not previously been treated with immune checkpoint inhibitors, which are medications that help the immune system fight cancer.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of metastatic uveal melanoma that cannot be surgically removed. They should have at least one tumor that can be measured and injected, and their overall health must meet certain criteria. If accepted, participants will receive the study treatments and will be monitored for their response and any side effects. It's important to note that those with certain health conditions or previous treatments may not qualify. This trial is currently recruiting participants, and those who join will contribute to understanding new options for treating this challenging cancer.

Gender

ALL

Eligibility criteria

• Key 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