Immunotherapy Targeting of Cytomegalovirus Antigens in Glioblastoma

ConditionGlioblastoma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-100

SponsorCharlotte Lemech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Histopathologically proven newly diagnosed primary glioblastoma.

Patients must have tumours which are MGMT-unmethylated.

Patients must be CMV-seropositive.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

PEP-CMV vaccine
Drug
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.

Treatment groups

26 Participants

are divided into 1 treatment group

Group A: GlioblastomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

2 weeks after the 3rd vaccine, which is approximately 12 weeks after consent.

Secondary outcomes

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charlotte Lemech

Lead sponsor

The University of New South Wales

Sponsor institution

The University of New South Wales

Collaborator

Source ClinicalTrials.gov

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