A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients

NCT04116411 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER
  • Karolinska Institutet

    collaborator OTHER
  • Cecilia Soderberg-Naucler

    lead OTHER

Principal Investigators

  • Giuseppe Stragliotto, MD, PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2027-09-16
Completion
2027-09-16

Countries

  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04116411 on ClinicalTrials.gov