LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma

Part of paid clinical trials in San Francisco, California.

Sponsor
Istari Oncology, Inc.
Study ID
NCT04479241
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lerapolturev — BIOLOGICAL
    Lerapolturev (5x10\^7 TCID50) delivered intratumorally via convection enhanced delivery (CED).
  • pembrolizumab — BIOLOGICAL
    Pembrolizumab (200 mg IV) given every 3 weeks.

Study Details

This Phase 2 single arm trial in patients with rGBM will characterize the efficacy, safety, tolerability and initial efficacy of lerapolturev intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and every 3 weeks, thereafter.

Key Dates

Start date
Oct 21, 2020
Status verified
Apr 2025
Primary completion
Jun 5, 2024
Completion
Jun 21, 2024

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: lerapolturev + pembrolizumab
    Lerapolturev delivered once intratumorally via convection enhanced delivery. Pembrolizumab given intravenously every 3 weeks.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 24 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143-
UConn HealthFarmingtonConnecticut06030-
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Duke University Medical CenterDurhamNorth Carolina27710-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State UniversityColumbusOhio43210-
Oregon Health and Science UniversityPortlandOregon97239-

Related coverage on Hipa.ai

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