A Phase 2 interventional study of IDH1-vac and IS-vac in Astrocytoma, IDH-Mutant, Grade 3 and Astrocytoma, IDH-Mutant, Grade 4, sponsored by German Cancer Research Center. Not yet recruiting at 13 sites in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by German Cancer Research Center · Phase 2, Interventional, and Treatment
STAR-VACC is a randomized double-blind controlled Phase 2 study assessing clinical efficacy of IDH1-vac in patients with newly diagnosed IDH1-mutant high-grade astrocytomas. Over a period of three years, patients with astrocytoma, WHO grade 3-4, will receive up to 12 vaccinations with either IDH1-vac or IS-vac. Screening will be performed after completion of radiotherapy. In the primary treatment phase consisting of 8 vaccinations, patients will receive concurrently SOC temozolomide (up to 12 cycles). Vaccinations will start approx. 4 to 8 weeks after completion of SOC radiotherapy.
Astrocytomas with mutations in the IDH1 gene are incurable diffusely infiltrating primary brain tumors in young adults with a median overall survival (OS) of 4-7 years. A principle characteristic largely contributing to this aggressive biology is the highly invasive behavior, which allows the active evasion of glioma cells from the main tumor mass not only into the surrounding but also into distant normal brain tissue.
The standard of care (SOC) consists of resection and radiotherapy alone or with concomitant temozolomide (TMZ) chemotherapy followed by 6 to 12 cycles of adjuvant TMZ. Recurrence and malignant transformation following SOC, however, are inevitable. To date, there are no effective measures preventing recurrence and/or malignant transformation. Achieving an effective prevention by stimulating the immune system to control transformed tumor cells could result in long-term remission of the disease.
A recently approved small molecule inhibitor of IDH demonstrated efficacy in preventing tumor growth in IDH-mutant low-grade gliomas. The drug is not yet approved for patients with high grade (grade 3 and grade 4) astrocytomas.
From an immunological point of view IDH1R132H represents an attractive tumor antigen specifically expressed in tumor but not normal cells. Patients with IDH1R132H-mutated gliomas may harbor mutation-specific T cells and antibodies, indicating that IDH1R132H is specifically presented to and recognized by the immune system in a mutation-specific manner.
The patient population will be molecularly defined and include IDH1R132H mutant grade 3 and grade 4 gliomas without co-deletion of 1p/19q and with loss of alpha-thalassemia/mental retardation syndrome X-linked (ATRX) expression. Patients must have received radiotherapy alone or with concomitant temozolomide (TMZ) chemotherapy as standard of care (SOC) prior to enrollment.
In STAR-VACC, IDH1-vac treatment will be added to SOC starting with adjuvant TMZ chemotherapy. Primary endpoint of the study is OS. Secondary endpoints include PFS and patient-reported outcomes (PROs). Immunological biomarkers are assessed in exploratory endpoints. Detailed molecular analyses from tumor tissue will allow for defining subgroups with differential benefit.
IDH1-vac demonstrated safety and biological activity in a Phase 1 first-in human clinical trial (NOA-16, ClinicalTrias.gov Identifier NCT02454634) when added to SOC and patients who received IDH1-vac showed favorable clinical courses.
The trial will be performed within the National Center of Tumor Diseases (NCT) network and additional sites of the Neurooncology Working Group (NOA) of the German Cancer Society.
STAR-VACC is a controlled double-blind clinical trial, two of three patients recruited to the trial will receive IDH1-vac, one of three will receive an immune stimulator (IS-vac). IDH1-vac contains an IDH1R132H 20-mer peptide emulsified in Montanide™ and will be administered subcutaneously in combination with topical imiquimod (Aldara®). IS-vac contains Montanide™ in combination with topical imiquimod (Aldara®).
In total 204 evaluable patients will be enrolled in the clinical trial. A futility analysis, assessing if the primary objective (improving OS) can be reached, is performed after patients have experienced 20% of the primary endpoint-related event (expected when 135 evaluable patients have been enrolled).
In an initial therapy phase, patients will receive up to 8 vaccinations every two (vaccination 1-4) or four weeks (5-8) followed by a boosting regime every 24 weeks (6 months). After four boosts (approximately three years after treatment initiation), end of study (EOS) is reached. Patients with stable disease at EOS will undergo watchful waiting with magnetic resonance imaging every 3 months and clinical assessment as part of the routine follow up.
434 studies on the registry are indexed under Astrocytoma; 79 are open to participants now.
This study's planned enrollment of 216 is above the median of 30 across 359 interventional studies indexed under Astrocytoma.
Browse Astrocytoma studies →German Cancer Research Center is the lead sponsor of 49 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Abnormal laboratory values for hematology, liver and renal function (serum creatinine). In detail the following values apply as exclusion criteria:
Patient in the Vaccination-Arm receives IDH1 peptide vaccine (IDH1-vac) with topical imiquimod (Aldara) and Temzolomid as background treatment.
Biological: IDH1-vac · Drug: Temozolomide (TMZ) · Drug: Imiquimod 5 % Cream
Patient in the Sham-Vaccination-Arm receives Immune stimulator (IS-vac) with topical imiquimod (Aldara) and Temzolomid as background treatment
Biological: IS-vac · Drug: Temozolomide (TMZ) · Drug: Imiquimod 5 % Cream
IDH1R132H peptide (300 μg peptide s.c.) emulsified in Montanide™ ISA 51 VG; 4 vaccinations every two weeks, 4 vaccinations every 4 weeks, followed by a boosting regime every 24 weeks.
Also known as: IDH1 peptide vaccine
33% DMSO / isotonic saline solution emulsified in Montanide™ ISA 51 VG; 4 sham-vaccinations every two weeks, 4 sham-vaccinations every 4 weeks, followed by a sham-boosting regime every 24 weeks.
Also known as: Immune stimulator
6 - 12 cycles, hard capsule
Also known as: L01A X03
at the site of injection of the vaccine, ready-to-use sachets containing 12.5 mg of imiquimod in 250 mg cream, 5%; it will be applied 15 min after each vaccination and left on the skin for 8 hours. 24 hours after the vaccination, a second dose will be applied and left on the skin for 8 hours.
Also known as: D06BB10
Overall Survival
The primary endpoint is OS, defined as time from date of randomization to death from any cause. OS was chosen over PFS as the primary endpoint, as no firm biomarker to discriminate pseudoprogression (inflammatory tissue reaction as a result of warranted local inflammation) versus progression according to the relevant imaging criteria (RANO 2.0) is established. Hence, PFS is not an ideal efficacy endpoint for immunotherapy in glioma
Time frame: Date of randomization to death from any cause, an average of 84 months.
Progression-free survival
Progression-free survival (PFS): This is the key secondary endpoint, defined as time from date of randomization to first documented disease progression by central assessment according to RANO 2.0 criteria or death, whichever occurs first.
Time frame: Date of randomization to disease progression, an average of 84 months.
Patient reported outcome
Quality of Life: As defined using PRO questionnaires of the EUonQol-Kit
Time frame: Date of screening to week 143
Plan to share: No
Start is estimated for Feb 2027; primary completion for Feb 2034, 84 months later.
Of 36 non-industry phase 2 interventional studies under Astrocytoma, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 52 and three quarters within 100. This study's planned 84 months is above that.
Counting every sponsor, half of 41 studies reached it within 67 months; a quarter within 41 and three quarters within 98.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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German Cancer Research Center