Trial · NCT04225039
Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma
NCT04225039, Phase 2, Active not recruiting, University of Pennsylvania; results first posted 2023-09-15
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma. Trials, record NCT04225039. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04225039
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma
- NCT number
- NCT04225039
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Glioblastoma
- Interventions
- INCMGA00012, INCAGN01876, SRS, Brain surgery
- First posted
- 2020-01-13
- Last updated
- 2026-06-23
- Results first posted
- 2023-09-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Radiographic Response (ORR) | 26 months | Per modified response assessment in neuro-oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in the sum of the products of the perpendicular diameters of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Incidence of Treatment-Emergent Adverse Events as Assessed by NCI CTCAE v 5.0 | 25 months | Adverse events will be evaluated by monitoring frequency, duration, and severity of adverse events (AEs) per NCI CTCAE v 5.0 |
| Secondary | Overall Survival | 84 months | OS, defined as the time from date of enrollment until death from any cause |
| Secondary | Progression Free Survival | 84 months | PFS, defined as the time from date of enrollment until the earliest date of disease progression (as determined by modified RANO criteria) or death due to any cause |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Radiographic Response (ORR) | 26 months | Per protocol, it was pre-specified to only include subjects in Cohort A and the subject must have received at least one dose of BOTH study drugs AND has received at least one fraction of SRS. Because of a protocol deviation, the data of 2 subjects is not included for efficacy analysis. | % of participants with response | NUMBER |
| SECONDARY | Incidence of Treatment-Emergent Adverse Events as Assessed by NCI CTCAE v 5.0 | 25 months | |||
| SECONDARY | Overall Survival | 84 months | |||
| SECONDARY | Progression Free Survival | 84 months |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Radiographic Response (ORR) | GITR + PD1, SRS (Cohort A) | 0 | 95% Confidence Interval 0 to 19 | % of participants with response |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 18 | |
| Overall Study | STARTED | Cohort B Sub-arm #1 | 8 | |
| Overall Study | STARTED | Cohort B Sub-arm #2 | 8 | |
| Overall Study | STARTED | Ineligible or Withdrew Consent | 5 | |
| Overall Study | COMPLETED | Cohort A | 15 | |
| Overall Study | COMPLETED | Cohort B Sub-arm #1 | 7 | |
| Overall Study | COMPLETED | Cohort B Sub-arm #2 | 8 | |
| Overall Study | COMPLETED | Ineligible or Withdrew Consent | 0 | |
| Overall Study | NOT COMPLETED | Cohort A | 3 | |
| Overall Study | NOT COMPLETED | Cohort B Sub-arm #1 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events840
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 | Anemia | Blood and lymphatic system disorders | Cohort A | 2 | 18 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Cohort B Sub-arm #1 | 0 | 8 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort B Sub-arm #2 | 1 | 8 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Ineligible or Withdrew Consent | 0 | 5 | 0 |
| other | Other: Enlarged lymph node | Blood and lymphatic system disorders | Cohort A | 0 | 18 | 0 |
| other | Other: Enlarged lymph node | Blood and lymphatic system disorders | Cohort B Sub-arm #1 | 0 | 8 | 0 |
| other | Other: Enlarged lymph node | Blood and lymphatic system disorders | Cohort B Sub-arm #2 | 1 | 8 | 1 |
| other | Other: Enlarged lymph node | Blood and lymphatic system disorders | Ineligible or Withdrew Consent | 0 | 5 | 0 |
| other | Other: Ectopic beat | Cardiac disorders | Cohort A | 0 | 18 | 0 |
| other | Other: Ectopic beat | Cardiac disorders | Cohort B Sub-arm #1 | 1 | 8 | 1 |
1 to 10 of 840Source ClinicalTrials.gov
See all 840 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 12 | 18 |
| Total, all-cause mortality | Cohort B Sub-arm #1 | 0 | 8 |
| Total, all-cause mortality | Cohort B Sub-arm #2 | 6 | 8 |
| Total, all-cause mortality | Ineligible or Withdrew Consent | 4 | 5 |
| Total, other adverse events | Cohort A | 18 | 18 |
| Total, other adverse events | Cohort B Sub-arm #1 | 8 | 8 |
| Total, other adverse events | Cohort B Sub-arm #2 | 8 | 8 |
| Total, other adverse events | Ineligible or Withdrew Consent | 0 | 5 |
| Total, serious adverse events | Cohort A | 8 | 18 |
| Total, serious adverse events | Cohort B Sub-arm #1 | 5 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04225039
GET https://conductscience.org/api/trials/v1/NCT04225039/events?page=2