Trial · NCT02986178
Lerapolturev in Recurrent Malignant Glioma
NCT02986178, Phase 2, Completed, Istari Oncology, Inc.; results first posted 2025-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lerapolturev in Recurrent Malignant Glioma. Trials, record NCT02986178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02986178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lerapolturev in Recurrent Malignant Glioma
- NCT number
- NCT02986178
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 121 participants, actual
- Lead sponsor
- Istari Oncology, Inc.
- Conditions
- Malignant Glioma
- Interventions
- lerapolturev, Lomustine
- First posted
- 2016-12-08
- Last updated
- 2025-07-11
- Results first posted
- 2025-07-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Radiographic Response | up to 5 years | Assess objective anti-tumor response based on iRANO criteria. |
| Primary | Duration of Objective Radiographic Response | up to 5 years | Assess time of confirmed response to confirmed disease progression or death |
| Secondary | Median Overall Survival | up to 5 years | Overall Survival (months), calculated using the Kaplan-Meier method |
| Secondary | Landmark Survival | at 24 and 36 months post-lerapolturev infusion | Overall survival (months) at 24 and 36 months, calculated using the Kaplan-Meier method |
| Secondary | Disease Control Rate | up to 5 years | the percentage of participants achieving complete response, partial response, or stable disease |
| Secondary | Safety of Lerapolturev | up to 52 weeks | Number of participants experiencing Grade 3, 4 or 5 adverse events considered possibly, probably, or definitely related to protocol treatment |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Objective Radiographic Response | up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Duration of Objective Radiographic Response | up to 5 years | months | MEDIAN | |
| SECONDARY | Median Overall Survival | up to 5 years | months | MEDIAN | |
| SECONDARY | Landmark Survival | at 24 and 36 months post-lerapolturev infusion | proportion probability | NUMBER | |
| SECONDARY | Disease Control Rate | up to 5 years | percentage of participants | NUMBER | |
| SECONDARY | Safety of Lerapolturev | up to 52 weeks | The safety set includes all participants who had an infusion catheter placed. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Objective Radiographic Response | Lerapolturev | 5 | Participants | ||
| Number of Participants With Objective Radiographic Response | Lerapolturev + Lomustine | 2 | Participants | ||
| Duration of Objective Radiographic Response | Lerapolturev | NA | 95% Confidence Interval NA to NA | months | |
| Duration of Objective Radiographic Response | Lerapolturev + Lomustine | NA | 95% Confidence Interval NA to NA | months | |
| Median Overall Survival | Lerapolturev | 7.0 | 95% Confidence Interval 5.8 to 9.1 | months | |
| Median Overall Survival | Lerapolturev + Lomustine | 7.1 | 95% Confidence Interval 4.0 to 8.1 | months | |
| Landmark Survival | Lerapolturev | Probability of being alive at 24 months | 0.12 | 95% Confidence Interval 0.06 to 0.21 | proportion probability |
| Landmark Survival | Lerapolturev + Lomustine | Probability of being alive at 24 months | 0.19 | 95% Confidence Interval 0.07 to 0.35 | proportion probability |
| Landmark Survival | Lerapolturev | Probability of being alive at 36 months | 0.07 | 95% Confidence Interval 0.02 to 0.15 | proportion probability |
| Landmark Survival | Lerapolturev + Lomustine | Probability of being alive at 36 months | 0.11 | 95% Confidence Interval 0.03 to 0.26 | proportion probability |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lerapolturev | 93 | |
| Overall Study | STARTED | Lerapolturev + Lomustine | 27 | |
| Overall Study | STARTED | Not Treated | 1 | |
| Overall Study | COMPLETED | Lerapolturev | 93 | |
| Overall Study | COMPLETED | Lerapolturev + Lomustine | 27 | |
| Overall Study | COMPLETED | Not Treated | 0 | |
| Overall Study | NOT COMPLETED | Lerapolturev | 0 | |
| Overall Study | NOT COMPLETED | Lerapolturev + Lomustine | 0 | |
| Overall Study | NOT COMPLETED | Not Treated | 1 |
Source ClinicalTrials.gov
Adverse events348
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | headache | Nervous system disorders | Lerapolturev | 63 | 94 | |
| other | headache | Nervous system disorders | Lerapolturev + Lomustine | 22 | 26 | |
| other | headache | Nervous system disorders | Overall | 85 | 121 | |
| other | hemiparesis | Nervous system disorders | Lerapolturev | 63 | 94 | |
| other | hemiparesis | Nervous system disorders | Lerapolturev + Lomustine | 22 | 26 | |
| other | hemiparesis | Nervous system disorders | Overall | 85 | 121 | |
| other | seizure | Nervous system disorders | Lerapolturev | 40 | 94 | |
| other | seizure | Nervous system disorders | Lerapolturev + Lomustine | 17 | 26 | |
| other | seizure | Nervous system disorders | Overall | 57 | 121 | |
| other | aphasia | Nervous system disorders | Lerapolturev | 35 | 94 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lerapolturev | 8 | 94 |
| Total, all-cause mortality | Lerapolturev + Lomustine | 4 | 26 |
| Total, all-cause mortality | Overall | 12 | 121 |
| Total, other adverse events | Lerapolturev | 94 | 94 |
| Total, other adverse events | Lerapolturev + Lomustine | 26 | 26 |
| Total, other adverse events | Overall | 121 | 121 |
| Total, serious adverse events | Lerapolturev | 37 | 94 |
| Total, serious adverse events | Lerapolturev + Lomustine | 12 | 26 |
| Total, serious adverse events | Overall | 50 | 121 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37072349 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lerapolturev vs Lerapolturev + Lomustine: Number of Participants With Objective Radiographic Response | Trial comparisons |
| Lerapolturev vs Lerapolturev + Lomustine: Safety of Lerapolturev | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02986178
GET https://conductscience.org/api/trials/v1/NCT02986178/events?page=2