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Virus Therapy

Lerapolturev + Pembrolizumab for Brain Cancer

Phase 2
Waitlist Available
Research Sponsored by Istari Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age
Recurrent supratentorial glioblastoma confirmed via prior histology by the site's neuropathologist or designate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new treatment for brain cancer that involves two drugs given a few weeks apart. The goal is to see if it is effective and safe.

Who is the study for?
This trial is for adults over 18 with recurrent glioblastoma, a type of brain tumor. Participants must have had prior vaccination against poliovirus and be able to stop blood thinners safely. They should not have used certain immune-targeting drugs recently or have tumors in specific brain areas that are excluded.Check my eligibility
What is being tested?
The study tests lerapolturev given directly into the tumor followed by pembrolizumab via IV every three weeks. It aims to assess how safe and effective this combination is for treating recurrent glioblastoma.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, immune system-related issues affecting organs, fatigue, blood disorders, increased risk of infections, and possible allergic reactions to components of the treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My brain tumor has come back and is confirmed by a specialist.
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My cancer is within or near the area of increased growth.
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My condition is at least 0.5 cm away from the brain's ventricles.
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My condition involves the brain and is at least 1 cm deep.
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My condition is at least 0.5 cm away from the corpus callosum.
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My cancer has returned for the 1st or 2nd time, confirmed by MRI or CT.
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I am mostly able to care for myself and carry out normal activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of treatment-emergent adverse events
Objective Response Rate (ORR), Duration of response (DOR) and Durable Radiographic Response (DRR)
Secondary outcome measures
Disease control rate (DCR)
Duration of disease control (DDC)
Progression free survival time
+1 more
Other outcome measures
Biomarker identification
Radiographic response/progression/PFS via iRANO

Trial Design

1Treatment groups
Experimental Treatment
Group I: LerapolturevExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750

Find a Location

Who is running the clinical trial?

Istari Oncology, Inc.Lead Sponsor
12 Previous Clinical Trials
389 Total Patients Enrolled
4 Trials studying Glioblastoma
161 Patients Enrolled for Glioblastoma
Lisa FranklinStudy DirectorIstari Oncology
1 Previous Clinical Trials
15 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographical scope of this clinical experiment?

"Currently, the medical trial is being administered at 10 separate centres across the United States. These include San Francisco, Boston and Columbus with other sites scattered in between. It would be wise to choose a facility closest to you so that travel demands can be kept to a minimum if participating."

Answered by AI

Are participants currently being accepted for this research endeavor?

"At the present moment, this trial is not actively enrolling candidates. It was initially posted on October 21st 2020 and last edited on November 30th 2021. However, for individuals seeking to join another study, there are 1463 clinical trials actively recruiting patients with glioblastoma and a further 961 studies researching pembrolizumab that require participants."

Answered by AI

How many subjects are enrolled in this clinical research project?

"Unfortunately, this medical study is no longer accepting new candidates as the trial was last updated on November 30th 2021. If you are searching for other potential treatment options there are currently 1,463 trials recruiting glioblastoma patients and 961 studies actively looking for participants to receive pembrolizumab treatments."

Answered by AI

For what maladies is pembrolizumab regularly prescribed?

"Pembrolizumab is extensively used for cancerous neoplasms and also has efficacy in treating unresectable melanoma, microsatellite instability high tumours, and relapse after chemotherapy."

Answered by AI

What is the ultimate objective of this research endeavor?

"Over the course of two years, this study will examine Objective Response Rate (ORR), Duration of response (DOR) and Durable Radiographic Response(DRR). Alongside these primary objectives are secondary metrics such as Progression free survival time calculated from lerapolturev infusion to death or progression, Survival assessed by Kaplan-Meier methods with variables observed at 6 month intervals up to 2 years post-infusion, and Disease control rate (DCR) which is based on protocol-defined criteria."

Answered by AI

Are there any other analyses that have been conducted concerning pembrolizumab?

"Pembrolizumab was first tested in 2010 by the City of Hope, and has since then been used in 251 completed studies. Furthermore, 961 ongoing trials are enrolling patients across San Francisco."

Answered by AI

Has the Food and Drug Administration certified pembrolizumab for public use?

"Taking into account the available safety data, pembrolizumab was assigned a score of 2 since this is only Phase 2 and there has been no clinical proof for its effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma
2020. "LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04479241.
~7 spots leftby Apr 2025
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