Glioblastoma (GBM)Phase 4STARGATENCT07546669
Efficacy of Zoster Vaccination in Glioblastoma Patients
A Phase 4 study testing Additional vaccination against shingles (herpes zoster) in people with Glioblastoma (GBM), run by University Hospital, Essen.
Trial summary
In modern practice a trimodality treatment has emerged as standard of care for histologically confirmed glioblastoma. We hypothesize that the additional vaccination against herpes zoster, after surgical resection followed by irradiation therapy and chemotherapy of patients with glioblastoma will lead to a superior… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Additional vaccination against shingles (herpes zoster)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2027to 31 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
- At least 18 years of age
- Written informed consent of the subject
- Life expectancy at least 3 months
- Participants of child-bearing age must use effective contraception
- Indication for definitive radiotherapy of glioblastoma or adjuvant radiation therapy of glioblastoma resection cavity according to interdisciplinary tumor board consensus and after radiation oncologists evaluation
- Histopathologically proven glioblastoma
- Incorporation of pre-neurochirurgical /-treatment PET/CT or/ and PET/MRI findings into the radiation therapy plan if patient undergoes PET/CT or/ and PET/MRI
Who cannot join
- Subjects will not be included in the study if any of the following criteria apply. General Exclusion Criteria:
- Subjects not able to give consent
- Subject without legal capacity who is unable to understand the nature, scope, significance, and con- sequences of this clinical trial
- Simultaneously participation in another clinical trial or participation in any clinical trial involving ad- ministration of an investigational medicinal product within 30 days prior to clinical trial beginning
- Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk may confound the trial results or may interfere with the subject's participation in this clinical trial
- Known or persistent abuse of medication, drugs or alcohol
Show all 22Show fewer
- Contraindications for radiotherapy (including active inflammatory disease)
- Known hypersensitivity against vaccine contra herpes zoster, or its constituents
- Gliomatosis cerebri at time of enrollment on any imaging or proved by histopathology
- Synchronous secondary malignancy
- Exclusion criteria regarding special restrictions for females as the treatment procedures require the highest degree of safety for the child:
- Current or planned pregnancy or nursing women
- Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep- tives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
- Indication-specific exclusion criteria in order to guarantee the highest degree of safety of all treatment procedures from a medical point of view:
- Primary infra-tentorial located glioblastoma (justification: specific subgroup of patients with different prognosis)
- Significant comorbidities at baseline, which would prevent possible chemotherapy, including:
- Platelet count < 100/nl ii. Absolute neutrophil count (ANC) < 1.5/nl iii. AST or ALT > 3 times the upper limit of normal iv. Total bilirubin above the normal range v. Serum creatinine > 1.7 mg/dl
- Patients with clinically significant liver-, renal- or blood disorder
- Patients with known additional significant neurological disease (e.g. primary seizure disorder*, de-mentia, progressive degenerative neurological disease, meningitis or encephalitis, hydrocephalus with increased intracranial pressure)
- Patients with brain tumor-related epilepsy, seizure-free under antiepileptic therapy are eligible
- Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts) or documented clinically signifi- cant arrhythmias
- History of HIV infection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Herpes Zoster Vaccine and Autologous CMV-specific T Cells as an Immunomodulatory Adjunct to Standard Neurosurgical Resection Radiochemotherapy in Glioblastoma
In modern practice a trimodality treatment has emerged as standard of care for histologically confirmed glioblastoma.
We hypothesize that the additional vaccination against herpes zoster, after surgical resection followed by irradiation therapy and chemotherapy of patients with glioblastoma will lead to a superior local control, overall and progression free survival. In an additional experimental setting based on patient preference the immunological effectiveness of the adoptive transfer of autologous polyclonal cytomegalovirus (CMV) specific T cells will be examined.
Read the detailed description
This multicenter study investigates novel immunomodulatory strategies in patients with histologically confirmed glioblastoma undergoing microsurgical resection at initial diagnosis.
In the randomized intervention arm, patients receive an EMA-approved, inactivated herpes zoster vaccine postoperatively, followed by standard radiotherapy or radiochemotherapy according to ESTRO/EANO guidelines. In a patient-preference experimental arm, the same regimen is combined with autologous CMV-specific T-cell adoptive transfer.
The control group undergoes neurosurgical resection and standard-of-care radiotherapy, with or without temozolomide, without additional herpes zoster vaccination or CMV-specific T-cell therapy.
Primary endpoint is overall survival (OS), while secondary endpoints include progression-free survival (PFS) and local tumor control, immunological response, safety, and tolerability. Exploratory endpoints incorporate patient-reported outcome measures (PROMs), assessing quality of life, cognitive function, and treatment-related symptoms. Interventions are delivered from surgical resection through completion of radiochemotherapy. We hypothesize that herpes zoster vaccination will improve survival and local tumor control, while adoptive CMV-specific T-cell therapy will provide additional immunotherapeutic benefit in this refractory glioblastoma population.
- Conditions
- Glioblastoma (GBM)
- Being tested
- Additional vaccination against shingles (herpes zoster), Standard of care treatment without additional vaccination
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional vaccination against shingles (herpes zoster)Biological
Based on patient-preference patients receive autologous CMV-specific T-cells additionally to vaccination contra herpes zoster after completion of radio(chemo-)therapy. Patients included in the experimental arm shall be HLA typed. Up to 6 intravenous infusions of in vitro-expanded T cells at a dose of 2 × 107 cells/m2 body surface area every 2 to 4 weeks shall be administered after clinical assessment. Patients shall continue standard-of-care treatment with temozolomide if indicated. Where possible, administration of autologous T-cells shall be scheduled to fall between chemotherapy treatment weeks to avoid concurrent infusions
Standard of care treatment without additional vaccinationOther
Standard of care treatment without additional vaccination
| Study group | Role | What they receive |
|---|---|---|
| Arm A Control Group, standard of care trimodality treatment (neurosurgical resection + R(C)Tx) | Active comparator | Standard of care trimodality treatment (neurosurgical resection + R(C)Tx) without additional vaccination Receives: Other: Standard of care treatment without additional vaccination |
| Arm B, interventional arm, trimodality treatment and vaccination against herpes zoster | Experimental | Trimodality treatment and vaccination against herpes zoster Receives: Biological: Additional vaccination against shingles (herpes zoster) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Overall survival defined as time from neurosurgical resection to death of any cause. Study time per subject from enrollment through the end of treatment after a maximum of 12 months (provided that additional CTx consolidation therapy is administered)
Overall survival
Measured: From enrollment through the end of treatment after a maximum of 12 months (provided that additional CTx consolidation therapy is administered)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start2 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Leiden University Medical Center, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Nika Guberina, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546669
- Sponsor's protocol ID
- 25-12859-BO
- Acronym
- STARGATE
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herpes Zoster Vaccine and Autologous CMV-specific T Cells as an Immunomodulatory Adjunct to Standard Neurosurgical Resection Radiochemotherapy in Glioblastoma
- ClinicalTrials.gov ID
- NCT07546669
- Acronym / sponsor ID
- STARGATE / 25-12859-BO
- Conditions
- Glioblastoma (GBM)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Leiden University Medical Center, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 2 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In modern practice a trimodality treatment has emerged as standard of care for histologically confirmed glioblastoma.
We hypothesize that the additional vaccination against herpes zoster, after surgical resection followed by irradiation therapy and chemotherapy of patients with glioblastoma will lead to a superior local control, overall and progression free survival. In an additional experimental setting based on patient preference the immunological effectiveness of the adoptive transfer of autologous polyclonal cytomegalovirus (CMV) specific T cells will be examined.
Detailed description
This multicenter study investigates novel immunomodulatory strategies in patients with histologically confirmed glioblastoma undergoing microsurgical resection at initial diagnosis.
In the randomized intervention arm, patients receive an EMA-approved, inactivated herpes zoster vaccine postoperatively, followed by standard radiotherapy or radiochemotherapy according to ESTRO/EANO guidelines. In a patient-preference experimental arm, the same regimen is combined with autologous CMV-specific T-cell adoptive transfer.
The control group undergoes neurosurgical resection and standard-of-care radiotherapy, with or without temozolomide, without additional herpes zoster vaccination or CMV-specific T-cell therapy.
Primary endpoint is overall survival (OS), while secondary endpoints include progression-free survival (PFS) and local tumor control, immunological response, safety, and tolerability. Exploratory endpoints incorporate patient-reported outcome measures (PROMs), assessing quality of life, cognitive function, and treatment-related symptoms. Interventions are delivered from surgical resection through completion of radiochemotherapy. We hypothesize that herpes zoster vaccination will improve survival and local tumor control, while adoptive CMV-specific T-cell therapy will provide additional immunotherapeutic benefit in this refractory glioblastoma population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A Control Group, standard of care trimodality treatment (neurosurgical resection + R(C)Tx) | Active comparator | Other: Standard of care treatment without additional vaccinationStandard of care trimodality treatment (neurosurgical resection + R(C)Tx) without additional vaccination |
| Arm B, interventional arm, trimodality treatment and vaccination against herpes zoster | Experimental | Biological: Additional vaccination against shingles (herpes zoster)Trimodality treatment and vaccination against herpes zoster |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
- At least 18 years of age
- Written informed consent of the subject
- Life expectancy at least 3 months
- Participants of child-bearing age must use effective contraception
Key exclusion criteria (22 listed)
- Subjects will not be included in the study if any of the following criteria apply. General Exclusion Criteria:
- Subjects not able to give consent
- Subject without legal capacity who is unable to understand the nature, scope, significance, and con- sequences of this clinical trial
- Simultaneously participation in another clinical trial or participation in any clinical trial involving ad- ministration of an investigational medicinal product within 30 days prior to clinical trial beginning
- Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk may confound the trial results or may interfere with the subject's participation in this clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional vaccination against shingles (herpes zoster)Based on patient-preference patients receive autologous CMV-specific T-cells additionally to vaccination contra herpes zoster after completion of radio(chemo-)therapy. Patients included in the experimental arm shall be HLA typed. Up to 6 intravenous infusions of in vitro-expanded T cells at a dose of 2 × 107 cells/m2 body surface area every 2 to 4 weeks shall be administered after clinical assessment. Patients shall continue standard-of-care treatment with temozolomide if indicated. Where possible, administration of autologous T-cells shall be scheduled to fall between chemotherapy treatment weeks to avoid concurrent infusions | Biological | Arm B, interventional arm, trimodality treatment and vaccination against herpes zoster |
| Standard of care treatment without additional vaccinationStandard of care treatment without additional vaccination | Other | Arm A Control Group, standard of care trimodality treatment (neurosurgical resection + R(C)Tx) |
Primary outcome
Overall Survival
Time frame: Overall survival defined as time from neurosurgical resection to death of any cause. Study time per subject from enrollment through the end of treatment after a maximum of 12 months (provided that additional CTx consolidation therapy is administered)
Overall survival
Time frame: From enrollment through the end of treatment after a maximum of 12 months (provided that additional CTx consolidation therapy is administered)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Additional vaccination against shingles (herpes zoster) in people with Glioblastoma (GBM), run by University Hospital, Essen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr.med. Guberina (+492017232054, strahlentherapie@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Overall survival defined as time from neurosurgical resection to death of any cause. Study time per subject from enrollment through the end of treatment after a maximum of 12 months (provided that additional CTx consolidation therapy is administered)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.