Trial · NCT07877415
A Multicenter Safety and Immunogenicity Window-of-opportunity Phase 1 Interventional Trial Assessing the Combination of IDH1 Vaccine (IDH1-vac) and Vorasidenib in Adult Patients With Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 (iVOCAL)
NCT07877415, Phase 1, Not yet recruiting, Heidelberg University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter Safety and Immunogenicity Window-of-opportunity Phase 1 Interventional Trial Assessing the Combination of IDH1 Vaccine (IDH1-vac) and Vorasidenib in Adult Patients With Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 (iVOCAL). Trials, record NCT07877415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877415
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Multicenter Safety and Immunogenicity Window-of-opportunity Phase 1 Interventional Trial Assessing the Combination of IDH1 Vaccine (IDH1-vac) and Vorasidenib in Adult Patients With Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 (iVOCAL)
- NCT number
- NCT07877415
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 45 participants, estimated
- Lead sponsor
- Heidelberg University
- Conditions
- Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4
- Interventions
- IDH1R132H-vac, Vorasidenib 40 mg Oral Tablet, Aldara - Imiquimod 5%
- First posted
- 2026-10-16
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | regime-limiting toxicity (RLT) | safety lead-in: week 1 to 13 main therapy: week 1 to 37 | * any injection site reaction of CTCAE grade 4 * any injection site reaction of CTCAE grade 3 that persists after two weeks * any transaminase elevation of CTCAE grade 4 * any grade 3 AE that is related to the treatment regime except for * nausea * vomiting, who have not received optimal treatment with antiemetics * diarrhea, who have not received optimal treatment with antidiarrheas * fatigue * edema cerebral of CTCAE grade 4 * death except for death due to disease progression |
| Secondary | Immunogenicity | through study completion, an average of 3 years | Immunogenicity, defined as presence of IDH1R132H-specific T-cells and/or antibody Responses in the peripheral circulation (all Arms) and/or the presence of IDH1R132H-specific T-cells in the tumor tissue (Arm 1, 2 only) |
| Secondary | Overall Survival | through study completion, an average of 3 years | Overall survival (OS) |
| Secondary | Progression-free survival | through study completion, an average of 3 years | Progression-free survival (PFS) according to RANO 2.0 |
| Secondary | Overall response rate | through study completion, an average of 3 years | Overall response rate (ORR) Response is defined as stable disease, partial response, complete response according to RANO 2.0. |
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/NCT07877415
GET https://conductscience.org/api/trials/v1/NCT07877415/registered