Clinical Trial Finder

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.

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.

Arms

Interventions