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← Adult Gliosarcoma

NCT03043391 · STUDY IN CONTEXT

Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Percentage of participants with unacceptable toxicity during the 14-day period post-PVSRIPO treatment

Source null

→

primary · POSTED

The percentage of participants requiring low-dose bevcizumab or steroid due to an inflammatory reaction secondary to an immune response to lerapolturev treatment

Source null

→

secondary · POSTED

Estimation of overall survival calculated at the time between lerapolturev infusion and death or last follow-up if the participant is alive using the Kaplan-Meier method

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-adult-gliosarcoma
nct id
NCT03043391
trial label
Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
3
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT03043391
    outcome key
    om-0000
    source section id
    NCT03043391-om-0000
    source outcome index
    0
    endpoint
    Percentage of Participants With Unacceptable Toxicity
    endpoint definition
    Percentage of participants with unacceptable toxicity during the 14-day period post-PVSRIPO treatment
    time origin
    14 days after treatment with PVSRIPO
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT03043391
    outcome key
    om-0001
    source section id
    NCT03043391-om-0001
    source outcome index
    1
    endpoint
    Percentage of Participants Requiring Low-dose Bevacizumab or Steroid
    endpoint definition
    The percentage of participants requiring low-dose bevcizumab or steroid due to an inflammatory reaction secondary to an immune response to lerapolturev treatment
    time origin
    1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT03043391
    outcome key
    om-0002
    source section id
    NCT03043391-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Estimation of overall survival calculated at the time between lerapolturev infusion and death or last follow-up if the participant is alive using the Kaplan-Meier method
    time origin
    up to 24 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT03043391
    outcome key
    om-0000
    arm key
    OG000
    arm label
    All Participants Treated
    regimen
    All participants received a single open-label infusion of lerapolturev
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03043391-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT03043391
    outcome key
    om-0001
    arm key
    OG000
    arm label
    All Participants Treated
    regimen
    All participants received a single open-label infusion of lerapolturev
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03043391-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT03043391
    outcome key
    om-0002
    arm key
    OG000
    arm label
    All Participants Treated
    regimen
    All participants received a single lerapolturev infusion.
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03043391-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-adult-gliosarcoma
    nct id
    NCT03043391
    harm key
    EG000
    source section id
    NCT03043391-ae
    event group key
    EG000
    event group label
    All Participants Treated
    serious affected
    5
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    5
    collection period
    All adverse events were collected up to 1 year; all-cause mortality was assessed for up to 2 years
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice