GlioblastomaPhase 1NCT06132438
Immunotherapy Targeting of Cytomegalovirus Antigens in Glioblastoma
A Phase 1 study testing PEP-CMV vaccine in people with Glioblastoma, run by Charlotte Lemech at 2 sites in Australia.
Trial summary
In Australia, glioblastoma (GBM) has a higher annual fatality rate than a variety of other cancers, such as melanoma, bladder, and kidney tumors. While the 5-year survival rate for other cancers, such as breast and prostate cancer, has increased, there have been no notable advancements in GBM during the past ten… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- PEP-CMV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesAustralia
- Study dates
- 22 Jul 2024to Sep 2027
- Phase
- Phase 1
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Histopathologically proven newly diagnosed primary glioblastoma.
- Patients must have tumours which are MGMT-unmethylated.
- Patients must be CMV-seropositive.
- The tumour must be supratentorial.
- Received debulking surgery. This includes complete or partial surgical resection. Biopsy alone is not acceptable.
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- Will have undergone standard concurrent radiotherapy (XRT) and temozolomide (TMZ) by the time of stage 2 participation consent.
- Patients who are being treated with stable or decreasing doses of dexamethasone (>/= 4 mg/day) or other steroid equivalent, at the time of post-XRT adjuvant TMZ initiation.
- Brain MRI (gadolinium-enhanced) within 31 days prior to the adjuvant TMZ.
- Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to stage 2 participant consent and should remain stable prior to the commencement of adjuvant TMZ.
- ECOG 0-2 if >/= 70 years. ECOG 0-1 if aged > 70 years.
- Life expectancy of > 12 weeks.
- Adequate bone marrow function:
- platelet count ≥ 100 x 109/L
- absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Haemoglobin ≥ 10g/dl.
- Adequate liver function:
- (alanine transaminase (ALT)/aspartate transaminase (AST) ≤ 3.0 times the upper limit of normal (ULN)).
- Total bilirubin ≤ 1.5 x ULN (Exception: Patient has known Gilbert's Syndrome or is suspected of having it, for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable).
- Adequate renal function:
- creatinine ≤ 1.5 x ULN
- Willing to comply with all study requirements, including treatment, timing and/or nature of required assessments
- Signed, written informed consent.
Who cannot join
- Pregnant or need to breastfeed during the study period (Negative serum pregnancy test required for women of childbearing potential). Not adhering to pregnancy prevention recommendations.
- Active infection requiring treatment or an unexplained febrile (> 39 C) illness within a week of starting the trial.
- Patients with previous inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabelled monoclonal antibodies.
- Prior allogeneic solid organ transplant. Currently receiving or ever received immunosuppressive therapy for an organ transplant.
- Active or prior documented autoimmune or immunosuppressive disease that has required systemic treatment (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed. Use of non-systemic topical steroids is allowed.
- Patients receiving immunosuppressive medication or prior use within 14 days before the first dose of investigational product are excluded, except for systemic steroids up to 4 mg dexamethasone per day for the management of CNS symptoms.
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- Patients on bevacizumab or who have received prior bevacizumab as management for their GBM
- Known human immunodeficiency virus infection and/or hepatitis B or C infections OR known to be positive for hepatitis B antigen (HBsAg)/Hepatitis B virus (HBV) DNA or Hepatitis C antibody or RNA.
- Patients with poorly controlled, unstable or severe intercurrent medical conditions such as renal, cardiac (congestive cardiac failure, myocardial infarction within 6 months, myocarditis), or pulmonary disease or other condition, therapy or laboratory abnormality that might confound the results of the study, interfere with the patient's participation, make administration of the study drug hazardous or make it difficult to monitor adverse effects, in the opinion of the treating physician.
- Prior conventional antitumour therapy, other than steroids, RT or TMZ therapy given for glioblastoma.
- Allergic or unable to tolerate TMZ for any reason. Any patient that successfully completed at least 5 weeks of TMZ during standard of care XRT/TMZ and whose blood counts meet the eligibility requirements (inclusion #13) within 6 weeks post XRT/TMZ is eligible.
- Patients receiving any other investigational drug therapy or having participated in an investigational drug/device study within 4 weeks prior to the first dose of study treatment.
- Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may impact the administration of study-related treatments or procedures.
- Radiographic or cytologic evidence of leptomeningeal or multifocal disease at any time prior to treatment.
- History of another malignancy within 2 years prior to registration. Patients with a history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least 2 years after definitive primary treatment.
- Receipt of other live and attenuated vaccines within 30 days of treatment product will be excluded.
- Unresolved toxicities from prior anticancer therapy, defined as not having resolved to NCI CTCAE grade 0 or 1, with the exception of alopecia.
- Patients with a prior severe hypersensitivity reaction to treatment with any monoclonal antibody and/or components of the study vaccine.
- Patients with any known severe allergies to gadolinium contrast agents.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Ingham Institute of Applied Medical Research
Liverpool, New South Wales, 2170
Stella Lee, +6187389000, Stella.Lee2@health.nsw.gov.au
Adam Cooper
- Recruiting
Scientia Clinical Research
Randwick, New South Wales, 2031
Regienald Gayaman, +6193825800, regienald.gayaman@scientiaclinicalresearch.com.au
Charlotte Lemech
About this study
Official title: Immunotherapy Targeting of Cytomegalovirus Antigens in Glioblastoma (INTERROGATE-GBM)
In Australia, glioblastoma (GBM) has a higher annual fatality rate than a variety of other cancers, such as melanoma, bladder, and kidney tumors. While the 5-year survival rate for other cancers, such as breast and prostate cancer, has increased, there have been no notable advancements in GBM during the past ten years, and the incidence and mortality patterns have barely changed between 1982 and 2011. In particular, GBM poses a challenging therapeutic dilemma for patients and physicians due to its aggressive biology and resistance to available treatments. Recent studies showed that cytomegalovirus (CMV) is expressed in GBM tumors, making it a good target for immunotherapy trials. This phase I trial aims to determine the safety and tolerability of the PEP-CMV vaccine in patients with newly diagnosed MGMT-unmethylated GBM in combination with one cycle of adjuvant temozolomide.
- Conditions
- Glioblastoma
- Being tested
- PEP-CMV vaccine
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP-CMV vaccineDrug
The PEP-CMV vaccine is a long synthetic peptide (PEP) made up of 26 amino acids that is derived from the human cytomegalovirus (CMV) matrix protein pp65 and has both MHC class I and II epitopes. A vaccine platform that initially consists of TMZ-induced lymphopenia and Td pre-conditioning will be used, with serial vaccinations of up to 12 times (maximum 20) being applied. To ensure the effectiveness of the future Td pre-conditioning, which is given right before the initial PEP-CMV vaccine, a Td booster is required at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Glioblastoma | Experimental | Not described Receives: Drug: PEP-CMV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with treatment-related adverse events according to NCI CTCAE V5.0.
To assess the safety of PEP-CMV vaccination in combination with adjuvant TMZ, the percentage of patients with unacceptable toxicity will be estimated within each arm. All patients who receive any PEP-CMV vaccine will be included in these analyses.
Measured: 2 weeks after the 3rd vaccine, which is approximately 12 weeks after consent.
Secondary outcomes (1)
Immunologic response as measured by peak number of T cells that secrete IFNy by ELISPOT in response to component A of PEP-CMV.
Measured: Through study completion, an average of 1.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start22 Jul 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charlotte Lemech
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor-investigator, Charlotte Lemech, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132438
- Sponsor's protocol ID
- INTERROGATE-GBM
- Status last verified
- Sep 2026
- First submitted
- 2 Nov 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy Targeting of Cytomegalovirus Antigens in Glioblastoma (INTERROGATE-GBM)
- ClinicalTrials.gov ID
- NCT06132438
- Acronym / sponsor ID
- INTERROGATE-GBM
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Charlotte LemechUniversity, hospital or other
- Collaborators
- The University of New South Wales
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Nov 2023 (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 Australia, glioblastoma (GBM) has a higher annual fatality rate than a variety of other cancers, such as melanoma, bladder, and kidney tumors. While the 5-year survival rate for other cancers, such as breast and prostate cancer, has increased, there have been no notable advancements in GBM during the past ten years, and the incidence and mortality patterns have barely changed between 1982 and 2011. In particular, GBM poses a challenging therapeutic dilemma for patients and physicians due to its aggressive biology and resistance to available treatments. Recent studies showed that cytomegalovirus (CMV) is expressed in GBM tumors, making it a good target for immunotherapy trials. This phase I trial aims to determine the safety and tolerability of the PEP-CMV vaccine in patients with newly diagnosed MGMT-unmethylated GBM in combination with one cycle of adjuvant temozolomide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma | Experimental | Drug: PEP-CMV vaccine |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥ 18 years.
- Histopathologically proven newly diagnosed primary glioblastoma.
- Patients must have tumours which are MGMT-unmethylated.
- Patients must be CMV-seropositive.
- The tumour must be supratentorial.
Key exclusion criteria (19 listed)
- Pregnant or need to breastfeed during the study period (Negative serum pregnancy test required for women of childbearing potential). Not adhering to pregnancy prevention recommendations.
- Active infection requiring treatment or an unexplained febrile (> 39 C) illness within a week of starting the trial.
- Patients with previous inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabelled monoclonal antibodies.
- Prior allogeneic solid organ transplant. Currently receiving or ever received immunosuppressive therapy for an organ transplant.
- Active or prior documented autoimmune or immunosuppressive disease that has required systemic treatment (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed. Use of non-systemic topical steroids is allowed.
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 |
|---|---|---|
| PEP-CMV vaccineThe PEP-CMV vaccine is a long synthetic peptide (PEP) made up of 26 amino acids that is derived from the human cytomegalovirus (CMV) matrix protein pp65 and has both MHC class I and II epitopes. A vaccine platform that initially consists of TMZ-induced lymphopenia and Td pre-conditioning will be used, with serial vaccinations of up to 12 times (maximum 20) being applied. To ensure the effectiveness of the future Td pre-conditioning, which is given right before the initial PEP-CMV vaccine, a Td booster is required at enrollment. | Drug | Glioblastoma |
Primary outcome
Percentage of participants with treatment-related adverse events according to NCI CTCAE V5.0.
Time frame: 2 weeks after the 3rd vaccine, which is approximately 12 weeks after consent.
To assess the safety of PEP-CMV vaccination in combination with adjuvant TMZ, the percentage of patients with unacceptable toxicity will be estimated within each arm. All patients who receive any PEP-CMV vaccine will be included in these analyses.
1 secondary outcome
Immunologic response as measured by peak number of T cells that secrete IFNy by ELISPOT in response to component A of PEP-CMV.
Time frame: Through study completion, an average of 1.5 years.
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 15 Sep 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP-CMV vaccine in people with Glioblastoma, run by Charlotte Lemech at 2 sites in Australia.
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 23 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Charlotte Lemech (+6193825800, charlotte.lemech@scientiaclinicalresearch.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with treatment-related adverse events according to NCI CTCAE V5.0. (time frame: 2 weeks after the 3rd vaccine, which is approximately 12 weeks after consent.). 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 15 Sep 2026.