Trial · NCT01403285
Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma
NCT01403285, Phase 1, Terminated, Immatics Biotechnologies GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma. Trials, record NCT01403285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01403285
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma
- NCT number
- NCT01403285
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Immatics Biotechnologies GmbH
- Conditions
- Glioblastoma
- Interventions
- Cyclophosphamide, IMA950 plus GM-CSF, IMA950, Imiquimod
- First posted
- 2011-07-27
- Last updated
- 2014-05-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of IMA950 administered with granulocyte macrophage colony stimulating factor (GM-CSF) and topical imiquimod together following a single low-dose application of cyclophosphamide. | Continuously for up to 1 year plus follow-up | Number of AEs and percentage of patients with AEs (listed per grade and MedDRA preferred terms) will be reported. |
| Primary | Immunogenicity of IMA950 | 6 time points (blood drawings) during the first 3 months (pre- and post-vaccination) | Vaccine-induced immune responses to peptides contained in IMA950 will be measured by multimer assay using peripheral blood. Percentage of immune responders (patients with at least one vaccine-induced immune response to IMA950 peptides) and percentage of multi-TUMAP responders (patients with vaccine-induced immune responses to ≥2 peptides in IMA950) will be reported. |
| Secondary | Immune status parameters | 6 time points (blood drawings) during the first 3 months on study (pre-vaccination and during vaccination period) | Relative frequencies and absolute numbers per µl blood of regulatory T-cells and (if sufficient cells are available) other immune cell populations will be measured from peripheral blood. Focus is on analysis of pre-vaccination frequencies. |
| Secondary | Biomarker assessment and correlation to clinical and immunological response | Analysis time points are before the first vaccination and 15 weeks thereafter | Serum levels of proteins and other factors that are indicative of the immune status of the patients will be measured (e.g TGF-beta) and will be correlated with immune response rates and clinical outcome. |
| Secondary | Clinical anti-tumor activity (response rate, 6-month progression-free survival) | Will be followed for 1 year (until end of study visit), overall survival will also be followed thereafter | Clinical response rates, survival and progression-free survival (PFS) will be followed. PFS at 6 month will be reported. |
| Secondary | Influence of corticosteroids on immunogenicity of IMA950 | 6 time points (blood drawings) during the first 3 months (pre- and post-vaccination) | Corticosteroid levels are not limited in this trial. It will descriptively reported whether the known immunosuppressive effects of corticosteroids are reflected in different immune response rates for patients treated or not treated with corticosteroids. |
| Secondary | Health-related quality of life | Monthly for 1 year | FACT-Br(4.0) questionnaire will be used to assess HRQL. HRQL scores (total, Trial Outcome Index, subscales) will be reported at baseline. Changes from baseline will also be evaluated. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
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.
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/NCT01403285
GET https://conductscience.org/api/trials/v1/NCT01403285/registered