Trial · NCT03893903
AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma
NCT03893903, Phase 1, Completed, German Cancer Research Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma. Trials, record NCT03893903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03893903
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma
- NCT number
- NCT03893903
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 69 participants, actual
- Lead sponsor
- German Cancer Research Center
- Conditions
- Malignant Glioma
- Interventions
- IDH1R132H peptide vaccine, Avelumab
- First posted
- 2019-03-28
- Last updated
- 2025-03-14
- Other registries' IDs
- eudract:2017-000587-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | safety and tolerability: Regime Limiting Toxicity | Primary treatment phase (week 43) | To determine safety and tolerability of repeated fixed dose vaccinations of the IDH1 peptide vaccine administered with topical imiquimod (Aldara®) alone (Arm 1) or in combination with Avelumab (Arm 2), or Avelumab alone (Arm 3). Primary endpoint is the Regime Limiting Toxicity (RLT) until End of Primary Treatment Phase. |
| Secondary | immunogenicity of the IDH1 peptide vaccine | End of primary treatment phase (week 43) | To assess immunogenicity of the IDH1 peptide vaccine alone or in combination with Avelumab. The main immunogenicity endpoint is the presence of IDH1R132H-specific T-cells and/or antibody responses in the peripheral circulation and/or the presence of IDH1R132H-specific T-cells in the tumor tissue |
| Secondary | Frequency of Treatment-Emergent Adverse Events (Assessment of Tolerability) | Time from baseline until EOS (end of study) (12 weeks after last treatment administration); up to 38 months | This endpoint includes all AEs (adverse event), their severity, SAEs (serious adverse event), the relation of AEs to the study treatment, dose modifications for toxicity and discontinuation of study treatment during the trial phase. Toxic effects will be graded according to CTCAE, current version. |
| Secondary | Objective response rate (ORR) to assess the efficacy of Avelumab in association with the number of non-synonymous mutations in the tumor tissue. | Time from baseline until end of the primary treatment phase (week 43) and at EOS (12 weeks after last treatment administration); up to 38 months | The ORR, defined as the proportion of patients with a treatment-induced hypermutator phenotype compared with a non-hypermutator phenotype showing complete response (CR), partial response (PR) or stable disease (SD) at end of the Primary Treatment Phase and at EOS compared to the baseline value (MRI at visit 7). ORR analysis will be based on the central disease assessment according to the iRANO criteria |
| Secondary | Overall survival (OS) | Time from the first study treatment date until death or end of observation (up to 38 months) | OS, defined as the time from the first study treatment date until death. For patients who do not die, time to death will be censored at the time of the end of observation. The end of observation is defined as the date of study termination as indicated by the corresponding entry of the CRF (case report form). If this date is not documented, the end of observation is defined as the last documented date. |
| Secondary | Progression-free survival (PFS) | Time from the day of first study treatment date, censored by the end of the observation (up to 38 months) | The PFS, defined as time from the day of first study treatment date to the day of tumor progression or the day of death of any cause (whichever occurs first), censored by the end of the observation. The end of observation is defined as the date of study termination as indicated by the corresponding entry of the CRF. If this date is not documented, the end of observation is defined as the last documented date. |
| Secondary | Objective response rate (ORR) | Time from baseline until end of the primary treatment phase (week 43) and at EOS (12 weeks after last treatment administration); up to 38 months | The ORR, defined as the proportion of patients showing complete response (CR), partial response (PR) or stable disease (SD) at end of the Primary Treatment Phase and at EOS compared to the baseline value (MRI at visit 7). ORR analysis will be based on the central disease assessment according to the iRANO criteria |
| Secondary | Association between immunogenicity and Objective response rate (ORR) | Time from baseline until EOS (12 weeks after last treatment administration); up to 38 months | To analyse the association between immunogenicity and the clinical outcome parameter. The clinical outcome will be evaluated by assessing the ORR. Logistic regression models will be used to explore the relationship between the relative changes in the immunologic parameters and ORR. |
| Secondary | Association between immunogenicity and Progression-free Survival (PFS) | Time from baseline until EOS (12 weeks after last treatment administration); up to 38 months | To analyse the association between immunogenicity and the clinical outcome parameter. The clinical outcome will be evaluated by assessing the PFS. Proportional Hazards models will be used to analyze the prognostic influence of relative changes in the immunologic parameters, for the PFS. |
| Secondary | Association between immunogenicity and Overall survival (OS) | Time from baseline until EOS (12 weeks after last treatment administration); up to 38 months | To analyse the association between immunogenicity and the clinical outcome parameters. The clinical outcome will be evaluated by assessing the OS. Proportional Hazards models will be used to analyze the prognostic influence of relative changes in the immunologic parameters, for the OS. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35599302 | 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 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/NCT03893903
GET https://conductscience.org/api/trials/v1/NCT03893903/registered