Lerapolturev With or Without Immune Therapy for Melanoma

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Istari Oncology, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A Phase 2 study to investigate the efficacy and safety of lerapolturev alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor.

Research Team

Eligibility Criteria

This trial is for adults with advanced melanoma that has worsened despite treatment with FDA-approved anti-PD-1/L1 therapy. Participants must be in good physical condition, not have certain types of melanoma or severe diseases, and agree to use contraception. They should also be willing to undergo tumor biopsies.

Inclusion Criteria

Has had confirmed progression of disease (PD) while receiving at least 6 weeks (> 1 dose) of an FDA-approved anti-PD-1/L1 therapy (as monotherapy or in combination) for the treatment of melanoma

Eastern Cooperative Oncology Group (ECOG) status of 0-1

Serum lactate dehydrogenase (LDH) levels ≤ 3 x upper limit of normal (ULN)

See 13 more

Exclusion Criteria

You need to take medication to prevent blood clots and cannot stop taking it for a few days before and after receiving each lerapolturev injection.

You have or had an autoimmune disease or a weakened immune system within the past 2 years.

Treatment with a live, attenuated vaccine within 4 weeks prior to Day 1

See 24 more

Treatment Details

Interventions

Anti-PD-1 Checkpoint Inhibitor (Checkpoint Inhibitor)
Lerapolturev (Other)
PVSRIPO (Virus Therapy)

Trial OverviewThe study is testing lerapolturev alone or combined with an anti-PD-1 checkpoint inhibitor to see how effective and safe they are for treating melanoma that hasn't responded to previous PD-1 inhibitors.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm 2: Lerapolturev and anti-PD-1Experimental Treatment2 Interventions

Lerapolturev (up to 1.6x10\^9 TCID50) administered via direct injection of up to 6 lesions given weekly for 7 weeks, followed by every 3 or 4 weeks thereafter. Anti-PD-1 therapy given as per the anti-PD-1 approved package insert.

Group II: Arm 1: Lerapolturev OnlyExperimental Treatment1 Intervention

Lerapolturev (up to 1.6x10\^9 TCID50) administered via direct injection of up to 6 lesions given weekly for 7 weeks, followed by every 3 weeks thereafter.