Trial · NCT02924038
A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)
NCT02924038, Phase 1, Terminated, Nicholas Butowski; results first posted 2024-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG). Trials, record NCT02924038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02924038
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)
- NCT number
- NCT02924038
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- Nicholas Butowski
- Conditions
- Glioma, Malignant Glioma, Astrocytoma, Grade II, Oligodendroglioma, Glioma, Astrocytic, Oligoastrocytoma, Mixed
- Interventions
- IMA950, poly-ICLC, Varlilumab
- First posted
- 2016-10-05
- Last updated
- 2024-06-14
- Results first posted
- 2024-06-14
- Limitations and caveats
Enrollment was closed earlier than expected due to industry sponsor's prioritization of other programs, the termination of Varliumab development, and Coronavirus disease of 2019 (COVID-19) related challenges during the period of enrollment. Appropriate reagents were not available for the CD4+ outcome measure. Due to the small number of participants, the biological/immunological evaluations are insufficiently powered to provide meaningful statistical significance.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Experiencing Regimen Limiting Toxicity (RLT) | up to 2 years | The proportion of participants experiencing and RLT defined as an adverse event judged to be possibly, probably or definitely associated with treatment that requires participants to be taken off study and no further injections will be given will be reported. |
| Primary | Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | Up to 2 years | The expansion of IMA950-reactive CD8+ T cell frequencies over post-vaccine periods was assessed by calculating the mean percentage of total IMA950 tetramer-positive CD8+ T cell per available post-vaccine time point. CD8+ T-cell response to the IMA950-epitope is defined to be positive when the percentage of tetramer-positive CD8+ T cells showed a four-fold or higher increase within at least one-time point in the post-vaccine phase relative to the corresponding percentage at the pre-vaccine. |
| Primary | Mean Percentage of CD4+ T-cell Responses in Pre- and Post-vaccine PBMC | Up to 2 years | The expansion of IMA950-reactive CD4+ T cell frequencies over post-vaccine periods was assessed by calculating the mean percentage of total IMA950 tetramer-positive CD4+ T cell per available post-vaccine time point. CD4+ T-cell response to the IMA950-epitope is defined to be positive when the percentage of tetramer-positive CD4+ T cells showed a four-fold or higher increase within at least one-time point in the post-vaccine phase relative to the corresponding percentage at the pre-vaccine. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Experiencing Regimen Limiting Toxicity (RLT) | up to 2 years | proportion of participants | NUMBER | |
| PRIMARY | Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | Up to 2 years | percentage of T cell responses | MEAN | |
| PRIMARY | Mean Percentage of CD4+ T-cell Responses in Pre- and Post-vaccine PBMC | Up to 2 years | Data not collected. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Experiencing Regimen Limiting Toxicity (RLT) | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 0 | proportion of participants | ||
| Proportion of Participants Experiencing Regimen Limiting Toxicity (RLT) | IMA950/Poly-ICLC subQ Only | 0 | proportion of participants | ||
| Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | Pre-Vaccine Cluster 3 Effector CD8 | 4.5 | Standard Deviation 4.2 | percentage of T cell responses |
| Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | IMA950/Poly-ICLC subQ Only | Pre-Vaccine Cluster 3 Effector CD8 | 7.3 | Standard Deviation 3.6 | percentage of T cell responses |
| Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | Post-Vaccine Cluster 3 Effector CD8 | 12.5 | Standard Deviation 8.0 | percentage of T cell responses |
| Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | IMA950/Poly-ICLC subQ Only | Post-Vaccine Cluster 3 Effector CD8 | 13.3 | Standard Deviation 8.3 | percentage of T cell responses |
| Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | Pre-vaccine Cluster 8 Effector memory | 2.2 | Standard Deviation 1.0 | percentage of T cell responses |
| Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | IMA950/Poly-ICLC subQ Only | Pre-vaccine Cluster 8 Effector memory | 2.7 | Standard Deviation 2.2 | percentage of T cell responses |
| Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | Post-vaccine Cluster 8 Effector memory | 5.9 | Standard Deviation 2.3 | percentage of T cell responses |
| Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC) | IMA950/Poly-ICLC subQ Only | Post-vaccine Cluster 8 Effector memory | 4.5 | Standard Deviation 4.6 | percentage of T cell responses |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 8 | |
| Overall Study | STARTED | IMA950/Poly-ICLC subQ Only | 6 | |
| Overall Study | Included in Biological Analysis | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 6 | |
| Overall Study | Included in Biological Analysis | IMA950/Poly-ICLC subQ Only | 5 | |
| Overall Study | COMPLETED | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 6 | |
| Overall Study | COMPLETED | IMA950/Poly-ICLC subQ Only | 4 | |
| Overall Study | NOT COMPLETED | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 2 | |
| Overall Study | NOT COMPLETED | IMA950/Poly-ICLC subQ Only | 2 |
Source ClinicalTrials.gov
Adverse events180
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 | Injection site reaction | General disorders | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 8 | 8 | 135 |
| other | Injection site reaction | General disorders | IMA950/Poly-ICLC subQ Only | 6 | 6 | 56 |
| other | Fatigue | General disorders | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 4 | 8 | 7 |
| other | Fatigue | General disorders | IMA950/Poly-ICLC subQ Only | 6 | 6 | 26 |
| other | Flu like symptoms | General disorders | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 4 | 8 | 36 |
| other | Flu like symptoms | General disorders | IMA950/Poly-ICLC subQ Only | 2 | 6 | 2 |
| other | Fever | General disorders | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 1 | 8 | 4 |
| other | Fever | General disorders | IMA950/Poly-ICLC subQ Only | 3 | 6 | 3 |
| other | Pain | General disorders | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 2 | 8 | 3 |
| other | Pain | General disorders | IMA950/Poly-ICLC subQ Only | 1 | 6 | 2 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 1 | 8 |
| Total, all-cause mortality | IMA950/Poly-ICLC subQ Only | 0 | 6 |
| Total, other adverse events | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 8 | 8 |
| Total, other adverse events | IMA950/Poly-ICLC subQ Only | 6 | 6 |
| Total, serious adverse events | IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV | 1 | 8 |
| Total, serious adverse events | IMA950/Poly-ICLC subQ Only | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37758193 | BACKGROUND |
Source PubMed
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 |
|---|---|---|---|---|---|
| R21CA233856 | Pilot randomized neoadjuvant vaccine with CD27-costimulation in low-grade glioma | OKADA, HIDEHO | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL CANCER INSTITUTE | 2019 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV vs IMA950/Poly-ICLC subQ Only: deaths from any cause | Trial comparisons |
| IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV vs IMA950/Poly-ICLC subQ Only: serious adverse events | 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/NCT02924038
GET https://conductscience.org/api/trials/v1/NCT02924038/events?page=2