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Not yet recruitingNCT07888647STAR-VACCUpdated Oct 22, 2026

IDH1-vac in Patients With Newly Diagnosed IDH1R132H-positive High-grade Astrocytomas

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

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Astrocytoma, IDH-Mutant, Grade 3
  • Astrocytoma, IDH-Mutant, Grade 4

Keywords

  • Glioblastoma
  • Glioma
  • Brain Neoplasms
  • Isocitrate Dehydrogenase
  • Mutation
  • Neoplasm Grading
  • IDH1
  • IDH1R132H
03

In context

Astrocytoma

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 →

Lead sponsor

German Cancer Research Center is the lead sponsor of 49 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients present with newly diagnosed histologically confirmed WHO grade 3 to 4 astrocytoma, IDH1R132H-positive (with or without measurable residual tumor after tumor resection or biopsy)
  2. Absence of chromosomal 1p/19q co-deletion in the tumor tissue
  3. Loss of nuclear ATRX expression in the tumor tissue (partial loss allowed)
  4. Availability of tumor tissue for molecular analysis (FFPE bulk tissue or cryo tissue) is required
  5. Patients have received radiotherapy (54 - 60 Gy) alone or combined with TMZ and radiotherapy /radiochemotherapy is completed at least 4 and no more than 8 weeks prior to informed consent and post-radiotherapy MRI must not show tumor progression. MRI must be completed within 3 to 6 weeks after radiotherapy.
  6. Patients must be immunocompetent (i.e., no concomitant treatment with dexamethasone (or equivalent), or receive stable/decreasing steroid levels not exceeding 2 mg/day dexamethasone (or equivalent) during the last 3 days prior to day of clinical screening; no severe lymphopenia)
  7. ≥18 years old ≤ 70 years old, smoking or non-smoking, of any ethnic origin and gender
  8. Karnofsky Performance Status ≥ 70
  9. Ability of patient to understand character and individual consequences of the clinical trial
  10. Evidence of the informed consent document personally signed and dated by the patient (or a witness in case the patient is unable to write), indicating that the patient has been informed of all pertinent aspects of the study and that the patient consents to participate in the trial.
  11. Women of child-bearing potential (WOCBP; i.e., those who have not undergone a hysterectomy, bilateral salpingectomy and bilateral oophorectomy or who have not been post-menopausal for at least 24 consecutive months) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of b-hCG) within 72 hours prior to the start of the IMP.
  12. Patients of any gender must be willing to practice birth control from the time of enrollment on this study until 12 weeks after last dose of study drug.
  13. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Progressive (incl. pseudoprogression) or recurrent disease within 3 to 6 weeks after SOC radiation therapy based on local MRI assessment
  2. Previous or concurrent experimental treatment for the tumor. This includes local therapies such as interstitial radiotherapy or local chemotherapy (i.e., BCNU wafers), loco-regional hyperthermia, and antiangiogenic therapy (such as bevacizumab)
  3. Antitumor treatment other than standard radiotherapy and/or standard TMZ chemotherapy. Daily metronomic TMZ or intensified dosing scheduled as a substitute for maintenance TMZ cycles are not allowed. (Dose reductions of standard TMZ chemotherapy are allowed.)
  4. Abnormal laboratory values for hematology, liver and renal function (serum creatinine). In detail the following values apply as exclusion criteria:

    1. Hemoglobin \< 10 g/dL (6.2 mmol/L)
    2. White blood cell count (WBC) decrease (\<3.0 x 109/L) or increase (>10.0 x 109/L)
    3. Absolute neutrophil count (ANC) decrease (\< 1.5 x 109/L)
    4. Platelet count decrease (\< 75 x 109/L)
    5. Bilirubin > 1.5 x ULN (upper limit of normal according to the performing lab's reference range)
    6. ALT > 3 x ULN
    7. AST > 3 x ULN
    8. GGT > 2.5 x ULN
    9. Serum creatinine increase (> 1.5 x ULN)
  5. Pregnancy and lactation
  6. Patients with history or presence of HIV and/or HBV/HCV positivity (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive
  7. Patients with severe infection(s) or signs/symptoms of infection within 2 weeks prior to the first administration of the study drug
  8. Patients who have received a live, attenuated vaccine within 4 weeks prior to the first administration of the study drug
  9. Patients with a prior solid organ transplantation or haematopoietic stem cell transplantation
  10. History of hypersensitivity to the IMP or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the IMP
  11. Participation in other interventional clinical trials or their observation period during the last 30 days before the first administration of the IMP.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
216 participants (estimated)

Study arms

  • Experimental
    Vaccination

    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

  • Sham comparator
    Sham-Vaccination

    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

Interventions

  • BiologicalIDH1-vac

    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

  • BiologicalIS-vac

    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

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What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Patient reported outcome

    Quality of Life: As defined using PRO questionnaires of the EUonQol-Kit

    Time frame: Date of screening to week 143

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Study locations

13 sites
  • Charité - University Medicine Berlin Department of Neurosurgery
    Berlin, 10117, Germany
  • University Hospital Bonn Department of Neurooncology
    Bonn, 53127, Germany
  • University Hospital Cologne Department of Neurology
    Cologne, 50937, Germany
  • University Hospital Carl Gustav Carus Dresden Department of Neurosurgery
    Dresden, 01307, Germany
  • University Hospital Erlangen Department of Neurosurgery
    Erlangen, 91054, Germany
  • University Hospital Essen Department of Neurology Clinical Neuro-Oncology
    Essen, 45147, Germany
  • University Hospital Frankfurt· Clinic for Neurology - Section Neurooncology
    Frankfurt, 60590, Germany
  • University Hospital Heidelberg Department of Neurology Division of Neuro-Oncology
    Heidelberg, 69120, Germany
  • Heidelberg University Faculty of Medicine in Mannheim Department of Neurology
    Mannheim, 68167, Germany
  • University Hospital Regensburg Neurology
    Regensburg, 93053, Germany
  • University Hospital Tuebingen Department of Neurology and lnterdisciplinary Neuro-Oncology
    Tübingen, 72076, Germany
  • University Hospital Ulm Department of Neurology /Center for NeuroOncology
    Ulm, 89081, Germany
  • University Hospital Wuerzburg Department of Neurosurgery and Outpatient Center
    Würzburg, 97080, Germany
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References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Sep 28, 2026
First posted
Oct 22, 2026
StartEst.
Feb 1, 2027
Primary completionEst.
Feb 1, 2034
CompletionEst.
Feb 1, 2035
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

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 ↗

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Registry details

Key details

Study ID
NCT07888647
Lead sponsor
German Cancer Research Center
Collaborators
National Center for Tumor Diseases, Heidelberg
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Feb 1, 2027 (estimated)
Primary completion
Feb 1, 2034 (estimated)
Completion
Feb 1, 2035 (estimated)
Last update
Oct 22, 2026

Study contacts

Michael Platten, Prof. Dr. med.
Contact
Michael.Platten@umm.de
+49-621-383-2213
Lukas Bunse, Prof. Dr. med. Dr. rer. nat.
Contact
lukas.bunse@umm.de
Michael Platten, Prof. Dr. med.
study director · Department of Neurology | Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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