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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

ConditionMetastatic Uveal Melanoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorReplimune, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RP2

    Biological/Vaccine

    Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.

  • Ipilimumab

    Biological/Vaccine

    Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody

  • Nivolumab

    Biological/Vaccine

    Nivolumab: Anti-PD-1 Monoclonal antibody

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Test Arm: RP2 + nivolumabExperimental treatment 2 interventions
Group B: Control Arm (Active Comparator): ipilimumab + nivolumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

OS is the time from the date of randomization to death from any cause.

Time frame
From Day 1 up to 3 years after last dose.
2

Progression Free Survival (PFS)

PFS is the time from randomization to first evidence of confirmed disease progression as assessed by BICR per RECIST 1.1 or death from any cause.

Time frame
From Day 1 up to 3 years after last dose.

Secondary outcomes

1

Number of patients with treatment-emergent adverse events (TEAEs)

The incidence of all TEAEs.

Time frame
From first dose up to 100 days after last dose.
2

Overall Response Rate (ORR)

ORR is the proportion of patients with a confirmed best overall response of complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1.

Time frame
Every 12 weeks from Day 1 up to 3 years after last dose.
3

Disease Control Rate (DCR)

DCR is the proportion of patients with a confirmed best overall response of CR, PR, or Stable Disease (SD), as assessed by BICR per RECIST 1.1.

Time frame
Every 12 weeks from Day 1 up to 3 years after last dose.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Replimune, Inc.

Lead sponsor

Source ClinicalTrials.gov
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