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Malignant GliomaPhase 2NCT02986178

Lerapolturev in Recurrent Malignant Glioma

A Phase 2 study testing lerapolturev and Lomustine in people with Malignant Glioma, run by Istari Oncology, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Glioma
What is being tested?
lerapolturev and Lomustine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
6 sitesUnited States
Study dates
1 Jun 2017to 3 Feb 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a recurrent (first or second recurrence only, including this recurrence; transformation from a lower grade tumor to a WHO grade IV malignant glioma will be considered a first recurrence) supratentorial WHO grade IV malignant glioma based on imaging studies with measurable disease (a minimum measurement of 1 cm and maximum of 5.5 cm of contrast-enhancing tumor) with prior histopathology consistent with a WHO grade IV malignant glioma confirmed by the site's neuropathologist or the neuropathologist's designate.
  • Male patients who are sexually active are eligible if he and/or his partner(s) meets the criteria outlined in the protocol. Female subjects are eligible if he and/or his partner(s) meets the criteria outlined in the protocol.
  • Age ≥ 18 years of age.
  • Karnofsky Performance Status (KPS) Score ≥ 70%.
  • Prothrombin and Partial Thromboplastin Times ≤ 1.2 x normal prior to biopsy.
  • Total bilirubin, serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), alkaline phosphatase ≤ 2.5 x normal prior to biopsy.
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  • Neutrophil count ≥ 1000 prior to biopsy.
  • Hemoglobin ≥ 9 prior to biopsy.
  • Platelet count ≥ 100,000/μL unsupported is necessary for eligibility on study; however, because of risks of intracranial hemorrhage with catheter placement, platelet count ≥ 125,000/μL is required for the patient to undergo biopsy and catheter insertion, which can be attained with the help of platelet transfusion.
  • Creatinine ≤ 1.2 x normal range prior to biopsy.
  • Positive serum anti-PV titer prior to biopsy.
  • The patient must have received a boost immunization with trivalent inactivated IPOL™ (Sanofi-Pasteur) at least 1 week, but less than 6 weeks, prior to administration of the study agent.
  • At the time of biopsy, prior to administration of virus, the presence of recurrent tumor must be confirmed by histopathological analysis.
  • A signed IRB-approve informed consent form (ICF).
  • Able to undergo brain MRI with and without contrast.

Who cannot join

  • Females who are pregnant or breast-feeding.
  • Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons, their designate, and the reviewer designated by the sponsor.
  • Patients with severe, active co-morbidity, defined as in the protocol.
  • Patients with a previous history of neurological complications due to PV infection.
  • Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used.
  • Patients may not have received tumor treating fields (≤ 1 week), chemotherapy or bevacizumab ≤ 4 weeks [except for nitrosourea and lomustine (≤ 6 weeks); metronomic dosed chemotherapy, such as daily temozolomide, etoposide or cyclophosphamide (≤ 1 week)] prior to starting the study drug.
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  • Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy.
  • Patients may not be less than 12 weeks from radiation therapy of the brain, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation.
  • Prior to enrollment, has not completed all standard of care treatments, including surgical procedure and radiation therapy (at least 59Gy) as outlined in the protocol.
  • Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of multiple areas of active (growing) disease (active multifocal disease); tumors with contrast-enhancing tumor component crossing the midline (crossing the corpus callosum); extensive subependymal disease (tumor touching subependymal space is allowed); or extensive leptomeningeal disease (tumor touching leptomeninges is allowed).
  • Patients with undetectable anti-tetanus toxoid immunoglobulin G (IgG).
  • Patients with known history of agammaglobulinemia.
  • Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for lerapolturev infusion.
  • Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups).
  • Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin.
  • For patients randomized prior to V7, a known history of hypersensitivity to lomustine, dacarbazine, or any components of lomustine.
  • Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Preston Robert Tisch Brain Tumor Center at Duke University

    Durham, North Carolina, 27710

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • UCSF Neurological Surgery

    San Francisco, California, 94941

Other trials in United States

About this study

Official title: A Multicenter Phase 2 Study of Oncolytic Polio/Rhinovirus Recombinant (Lerapolturev) in Recurrent WHO Grade IV Malignant Glioma Patients

This is a phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma.

Read the detailed description

This is a Phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma. The objective of this study is to investigate the safety and efficacy (anti-tumor response and survival) of lerapolturev in recurrent WHO grade IV malignant glioma.

Patients will be administered lerapolturev intratumorally via convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. Retreatment with lerapolturev is allowed, provided retreatment eligibility criteria are met.

Being tested
lerapolturev, Lomustine
Keywords
Glioblastoma, Glioma, PVSRIPO, Duke, Pro00077024, Brain tumor, Istari, Recurrent, GBM, rGBM
Medical subject headings
Glioma, Glioblastoma, Brain Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lerapolturevBiological

    Also called PVSRIPO

    A single dose of lerapolturev, an oncolytic polio/rhinovirus recombinant

  • LomustineDrug

    Also called gleostine

    one cycle of oral lomustine

Study groups in NCT02986178
Study groupRoleWhat they receive
lerapolturevExperimentallerapolturev administered once intratumorally by convection-enhanced delivery
Receives: Biological: lerapolturev
lerapolturev + lomustineExperimentallerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
Receives: Biological: lerapolturev; Drug: Lomustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Objective Radiographic Response

    Assess objective anti-tumor response based on iRANO criteria.

    Measured: up to 5 years

  2. Duration of Objective Radiographic Response

    Assess time of confirmed response to confirmed disease progression or death

    Measured: up to 5 years

Secondary outcomes (4)

  1. Median Overall Survival

    Overall Survival (months), calculated using the Kaplan-Meier method

    Measured: up to 5 years

  2. Landmark Survival

    Overall survival (months) at 24 and 36 months, calculated using the Kaplan-Meier method

    Measured: at 24 and 36 months post-lerapolturev infusion

  3. Disease Control Rate

    the percentage of participants achieving complete response, partial response, or stable disease

    Measured: up to 5 years

  4. Safety of Lerapolturev

    Number of participants experiencing Grade 3, 4 or 5 adverse events considered possibly, probably, or definitely related to protocol treatment

    Measured: up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2016 (estimated)
  2. Study start1 Jun 2017
  3. Primary completion30 Sep 2022
  4. Study completion3 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Study began as parallel (randomized two arm study) and was revised to single group.
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02986178
Sponsor's protocol ID
Pro00077024
Status last verified
Apr 2025
First submitted
6 Dec 2016
Last updated
11 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brown MC, Beasley GM, McKay ZP, Yang Y, Desjardins A, Randazzo DM, Landi D, Ashley DM, Bigner DD, Nair SK, Gromeier M. Intratumor childhood vaccine-specific CD4+ T-cell recall coordinates antitumor CD8+ T cells and eosinophils. J Immunother Cancer. 2023 Apr;11(4):e006463. doi: 10.1136/jitc-2022-006463.

    PubMed 37072349

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lerapolturev and Lomustine in people with Malignant Glioma, run by Istari Oncology, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Objective Radiographic Response (time frame: up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02986178, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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