NCT04116411

A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients

A Multicenter Randomized Double-blinded Controlled Phase 2 Study Evaluating the Efficacy of Valganciclovir as add-on Therapy in Glioblastoma Patients

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Cecilia Soderberg-Naucler · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy and safety of the anti-CMV drug valganciclovir vs placebo as add-on therapy in patients with glioblastoma. Valganciclovir is approved for treatment of cytomegalovirus (CMV) infections, but may also have anti-tumoral effects. Current evidence imply that most glioblastomas are CMV positive and that the virus can affect tumor aggressiveness.

Detailed description

Adult patients will either be randomized to standard treatment (temozolomide and radiation therapy) + placebo tablets or to standard treatment + valganciclovir. Patients are randomized using 1 to 1 distribution of the patients between the treatment groups and are stratified according to methylation status of the MGMT promoter; equal proportion of patients are included in each group. A maximum of 30% of patients with methylated MGMT promoter are allowed into the study (to harmonise with current data used for statistical power calculation), as MGMT promotor methylation status is prognostic for patient survival. Patients must enter the study within 10 weeks after surgery. Full dose treatment with 900mgs of Valganciclovir is given twice daily for 6 weeks, thereafter 900 mgs daily during 98 weeks (total treatment of 24 months). Valganciclovir is available in 450 mg tablets. The dose of Valganciclovir will be adjusted according to renal function. This study will be performed in compliance with the protocol, ICH-GCP, the declaration of Helsinki and applicable Swedish regulatory requirements. The study discontinuation criteria are as follows: * Withdrawal of consent * An adverse event which requires discontinuation of the trial medication or results in * inability to continue to comply with trial procedures * Disease progression which results in inability to continue to comply with trial * procedures * Major Protocol deviations * Exclusion criteria met

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Valganciclovir Tablets	Valganciclovir treatment of glioblastoma
DRUG	Temozolomide 120 mg	Chemotherapy
RADIATION	Radiotherapy 60 Gy	Radiation therapy
DRUG	Placebo oral tablet	Placebo treatment of glioblastoma

Timeline

• Start date: 2019-09-04
• Primary completion: 2027-09-16
• Completion: 2027-09-16
• First posted: 2019-10-04
• Last updated: 2025-12-22

Locations

3 sites across 2 countries: Norway, Sweden