Trial · NCT02465268
Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme
NCT02465268, Phase 2, Completed, University of Florida; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme. Trials, record NCT02465268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02465268
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme
- NCT number
- NCT02465268
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 175 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Glioblastoma Multiforme, Glioblastoma, Malignant Glioma, Astrocytoma, Grade IV, GBM
- Interventions
- pp65-shLAMP DC with GM-CSF, unpulsed PBMC and saline, Td, Saline, pp65-flLAMP DC with GM-CSF
- First posted
- 2015-06-08
- Last updated
- 2025-01-14
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3) | From date of first vaccine until the date of death, up to 48 months | Kaplan-Meier survival curves and the log rank test will be used to characterize and compare OS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). OS will be defined as the time between first vaccination and death and will be censored at the last follow-up if death has not occurred. |
| Secondary | Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3) | From date of first vaccine until time disease progression or death without prior progression/recurrence, up to 48 months | Calculated as dated of first vaccine to date first progression/recurrence or death. Kaplan-Meier survival curves and the log rank test will be used to characterize and compare PFS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). PFS is defined as the time between first vaccination and first documentation of either disease progression/recurrence, or death without prior progression/recurrence. |
| Secondary | ELISPOT Assay (pp65) | baseline, post-vaccine #3 | Within patient changes from baseline to vaccine 3. |
| Secondary | Flow Cytometric Analysis (T Cell) | baseline, post-vaccine #3 | Percentage of circulating cellular subsets of T cells within PBMCs. |
| Secondary | Cytokine Array Analysis (IFN-g) | baseline, post-vaccine #3 | Change in concentration (pg/mL) of IFN-g as measured by multiplex array from Baseline (V1) to post-Vaccine #3. |
| Secondary | ELISPOT Assay (Actin) | baseline, post-vaccine #3 | Within patient changes from baseline to vaccine 3. |
| Secondary | Flow Cytometric Analysis (NK Cell) | baseline, post-vaccine #3 | Percentage of circulating cellular subsets of NK cells within PBMCs. |
| Secondary | Flow Cytometric Analysis (CD4.CD25 T Reg) | baseline, post-vaccine #3 | Percentage of circulating cellular subsets of CD4.CD25 T Reg within PBMCs. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3) | From date of first vaccine until the date of death, up to 48 months | Survival in Patients receiving vaccine vs placebo. | months | MEDIAN |
| SECONDARY | Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3) | From date of first vaccine until time disease progression or death without prior progression/recurrence, up to 48 months | Progression free survival in patients receiving vaccine vs placebo. | months | MEDIAN |
| SECONDARY | ELISPOT Assay (pp65) | baseline, post-vaccine #3 | Participants in each arm who received at least 3 DC vaccines. | spot forming units (SFU) | MEAN |
| SECONDARY | Flow Cytometric Analysis (T Cell) | baseline, post-vaccine #3 | Only participants who received at least 3 DC vaccines are included. | percentage of PBMC | MEAN |
| SECONDARY | Cytokine Array Analysis (IFN-g) | baseline, post-vaccine #3 | Only participants who received at least 3 DC vaccines are included in the analysis | pg/mL | MEAN |
| SECONDARY | ELISPOT Assay (Actin) | baseline, post-vaccine #3 | Participants in each arm who received at least 3 DC vaccines. | spot forming units (SFU) | MEAN |
| SECONDARY | Flow Cytometric Analysis (NK Cell) | baseline, post-vaccine #3 | Only participants who received at least 3 DC vaccines are included. | percentage of PBMC | MEAN |
| SECONDARY | Flow Cytometric Analysis (CD4.CD25 T Reg) | baseline, post-vaccine #3 | Only participants who received at least 3 DC vaccines are included. | percentage of PBMC | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3) | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 16.9 | 95% Confidence Interval 12.7 to 22.8 | months | |
| Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3) | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 16.2 | 95% Confidence Interval 13.8 to 19.2 | months | |
| Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3) | Unpulsed PBMC and Saline (Arm 3) | 20.6 | 95% Confidence Interval 15.4 to 30.2 | months | |
| Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3) | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 6.1 | 95% Confidence Interval 3.9 to 11.0 | months | |
| Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3) | Plus pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 6.4 | 95% Confidence Interval 4.2 to 10.8 | months | |
| Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3) | Unpulsed PBMC and Saline (Arm 3) | 7.1 | 95% Confidence Interval 3.9 to 14.8 | months | |
| ELISPOT Assay (pp65) | Arm 1: pp65-shLAMP DC With GM-CSF and Td | 126.3 | Standard Deviation 759.9 | spot forming units (SFU) | |
| ELISPOT Assay (pp65) | Arm 2: pp65-flLAMP DC With GM-CSF and Td | 48.4 | Standard Deviation 377.5 | spot forming units (SFU) | |
| ELISPOT Assay (pp65) | Arm 3: Unpulsed PBMC and Saline | -162.7 | Standard Deviation 1075.4 | spot forming units (SFU) | |
| Flow Cytometric Analysis (T Cell) | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | -0.1 | Standard Deviation 11.1 | percentage of PBMC |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 52 | |
| Overall Study | STARTED | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 50 | |
| Overall Study | STARTED | Unpulsed PBMC and Saline (Arm 3) | 52 | |
| Overall Study | COMPLETED | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 36 | |
| Overall Study | COMPLETED | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 34 | |
| Overall Study | COMPLETED | Unpulsed PBMC and Saline (Arm 3) | 41 | |
| Overall Study | NOT COMPLETED | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 16 | |
| Overall Study | NOT COMPLETED | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 16 | |
| Overall Study | NOT COMPLETED | Unpulsed PBMC and Saline (Arm 3) | 11 |
Source ClinicalTrials.gov
Adverse events129
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 | CD4 Count | Blood and lymphatic system disorders | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 1 | 36 | |
| other | CD4 Count | Blood and lymphatic system disorders | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 0 | 34 | |
| other | CD4 Count | Blood and lymphatic system disorders | Unpulsed PBMC and Saline (Arm 3) | 0 | 41 | |
| other | Lymphopenia | Blood and lymphatic system disorders | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 4 | 36 | |
| other | Lymphopenia | Blood and lymphatic system disorders | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 6 | 34 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Unpulsed PBMC and Saline (Arm 3) | 5 | 41 | |
| other | Neutrophils/granulocytes | Blood and lymphatic system disorders | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 1 | 36 | |
| other | Neutrophils/granulocytes | Blood and lymphatic system disorders | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 0 | 34 | |
| other | Neutrophils/granulocytes | Blood and lymphatic system disorders | Unpulsed PBMC and Saline (Arm 3) | 0 | 41 | |
| other | Platelets | Blood and lymphatic system disorders | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 1 | 36 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 28 | 36 |
| Total, all-cause mortality | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 31 | 34 |
| Total, all-cause mortality | Unpulsed PBMC and Saline (Arm 3) | 31 | 41 |
| Total, other adverse events | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 16 | 36 |
| Total, other adverse events | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 11 | 34 |
| Total, other adverse events | Unpulsed PBMC and Saline (Arm 3) | 13 | 41 |
| Total, serious adverse events | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | 8 | 36 |
| Total, serious adverse events | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | 6 | 34 |
| Total, serious adverse events | Unpulsed PBMC and Saline (Arm 3) | 5 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA175517 | Efficacy of Dendritic Cell Vaccines Targeting CMV in Glioblastoma (phase 2 DC vaccine) | MITCHELL, DUANE A.; SAMPSON, JOHN H. | UNIVERSITY OF FLORIDA | NATIONAL CANCER INSTITUTE | 2015 to 2020 |
Source NIH RePORTER
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.
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/NCT02465268
GET https://conductscience.org/api/trials/v1/NCT02465268/results?page=2