Replimune, Inc, RP2-202, Randomized, Phase 2/3, Metastatic Uveal Melanoma,RP2, (IRB# 3812))

What is the Purpose of this Study?

To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on progression free survival (PFS) Secondary Objectives To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on overall response rate (ORR) To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on duration of responses (DOR) To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on duration of responses (DOR) To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on duration of responses (DOR) To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on duration of clinical benefit (DOCB) To characterize the relative safety profiles of patients treated with RP2 + nivolumab to patients treated with ipilimumab + nivolumab To compare the incidence of immune mediated TEAEs (imAEs) in patients treated with RP2 + nivolumab relative to ipilimumab + nivolumab

Eligibility

* 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.

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.

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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details

Disease Type/Condition

Eye and Orbit, Liver, Melanoma

Principal Investigator

Mehmi, Inderjit

Co-Investigators

Cathie T Chung, Justin Moyers, Kristopher Wentzel, Navid Hafez, Omid Hamid, Vi K. Chiu

Age Group

Adult

Phase

II/III

IRB Number

STUDY00003812

ClinicalTrials.gov ID

NCT06581406

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org