NCT06132438

Immunotherapy Targeting of Cytomegalovirus Antigens in Glioblastoma

Immunotherapy Targeting of Cytomegalovirus Antigens in Glioblastoma (INTERROGATE-GBM)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Charlotte Lemech · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
DRUG	PEP-CMV vaccine	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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-09-01
• Completion: 2026-09-01
• First posted: 2023-11-15
• Last updated: 2023-11-15