A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients

2023-504846-73-01 Protocol Protocol number 8 Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 2 EU/EEA countries · 3 sites · Protocol Protocol number 8

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 220
Countries 2
Sites 3

Glioblstoma WHO grade IV

Compare median overall survival (OS) time in patients with newly-diagnosed glioblastoma and less than 1 cm3 remaining contrast enhancing tumor postoperatively treated with and without valganciclovir as add-on to standard therapy. The primary endpoint is median OS at End of Study (EoS) when the last patient has reached …

Key facts

Sponsor
Karolinska Institutet
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Neoplasms [C04], Diseases [C] - Virus Diseases [C02]
Decision date (initial)
2024-10-29
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Nordic Cancer Union · Region Stockholm · Swedish Medical Research Council

External identifiers

EU CT number
2023-504846-73-01
EudraCT number
2019-001083-30
ClinicalTrials.gov
NCT04116411

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

Compare median overall survival (OS) time in patients with newly-diagnosed glioblastoma and less than 1 cm3 remaining contrast enhancing tumor postoperatively treated with and without valganciclovir as add-on to standard therapy. The primary endpoint is median OS at End of Study (EoS) when the last patient has reached 30 months. OS time is measured from time of resection until death for any reason.

Secondary objectives 10

  1. Compare different survival and toxicity parameters in patients with newly-diagnosed glioblastoma treated with and without valganciclovir as add-on to standard therapy.The secondary endpoints are:
  2. 1. One (12 months) and two year (24 months) survival rates
  3. 2. Median progression free survival time; time from resection to objective demonstration of disease progression or death (PFS), whichever occurs first
  4. 3. Quality of life assessments as assessed by EORTC QLQ C30 and BN20 questionnaires at base line and at 3, 6, 9, 12, 15, 18, 21, 24 and 30 months
  5. 4. Proportion of patients with progressive disease at 12 and 24 months
  6. 5. Proportion of patients with stable disease at 12 and 24 months
  7. 6. Subgroup analyses will be performed of treatment response according to CMV status (grade of infection or serostatus versus median OS, one and two year survival rates, and PFS time).
  8. 7. Subgroup analysis for patients receiving Optune treatment (median OS, one and two year survival rates, and PFS time).
  9. 8. Subgroup analysis for patients needing surgical interventions during the first 24 months (median OS, one and two year survival rates, and PFS time).
  10. 9. Evaluation of safety and tolerance for valganciclovir as add-on to standard therapy

Conditions and MedDRA coding

Glioblstoma WHO grade IV

VersionLevelCodeTermSystem organ class
20.0 PT 10018337 Glioblastoma multiforme 100000004864

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
Assessing the efficacy and safety of anti-CMV treatment in patients with glioblastoma
 Randomised Controlled Double [{"id":87919,"code":2,"name":"Investigator"},{"id":87921,"code":3,"name":"Monitor"},{"id":87922,"code":4,"name":"Analyst"},{"id":87920,"code":5,"name":"Carer"},{"id":87918,"code":1,"name":"Subject"}] A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients: Valganciclovir or placebo

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2023-504846-73-00 A multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy of valganciclovir as add-on therapy in glioblastoma patients Karolinska Institutet

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. Patients aged 18 years or older
  2. Patients with newly diagnosed glioblastoma, IDHwt, WHO grade IV
  3. Patients were a radical tumor resection has been achieved; no more than 1 cm3 remaining contrast enhancing tumor as assessed by postoperative MRI or CT is allowed
  4. Patients eligible for standard treatment with radiation therapy combined with concomitant and adjuvant temozolomide
  5. Patients were tumor MGMT promoter methylation status is available
  6. Patients with KPS >= 70 and ECOG/WHO <= 2
  7. Patients providing written informed consent
  8. Patients cooperative and able to complete all study procedures
  9. Females of child-bearing age must have a negative pregnancy test at screening (all premenopausal women and in women under the age of 55 were menstrual status cannot be ascertained). Female patients must agree to utilize a highly efficient birth control method throughout the study period (Pearl index <1, e.g: oral contraception with gestagens, transdermal contraceptives, implants, injectables, intrauterine devices, bilateral tubal occlusion, sexual abstinence or vasectomised partner). The birth control method must be used until 6 months after last dose of study drug. Pregnancy testing will be performed at monthly intervals due to high teratogenic potential of valganciclovir, and continue for 6 months after the Study drug has been discontinued. Men are recommended to use condoms with female fertile partners during, and for 6 months following treatment with valganciclovir.
  10. Patients must be enrolled and start their first dose IMP within 10 weeks after surgery

Exclusion criteria 12

  1. Patients allergic to, or who do not tolerate valganciclovir, aciclovir or valaciclovir
  2. Patients intolerant to ingredients of the study drug tablets
  3. Patients with decreased cognitive function (below 24 in MMSE test)
  4. Pregnant or lactating females
  5. Patients not signing informed consent
  6. Patients participating in other interventional trials
  7. Neutrophil count < 1,5 cells/ 109/L
  8. Platelet count < 150 cells/ 109/L
  9. HGB < 80 g/L
  10. Abnormal renal function (GFR < 30)
  11. Secondary glioblastoma or IDH mutated glioblastoma
  12. Unfit or for any other reason judged ineligible by investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Compare median overall survival (OS) time in patients with newly-diagnosed glioblastoma and less than 1 cm3 remaining contrast enhancing tumor postoperatively treated with and without valganciclovir as add-on to standard therapy. The primary endpoint is median OS at End of Study (EoS) when the last patient has reached 30 months. OS time is measured from time of resection until death for any reason.

Secondary endpoints 1

  1. Compare different survival and toxicity parameters in patients with newly-diagnosed glioblastoma treated with and without valganciclovir as add-on to standard therapy.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Valganciclovir

SCP13245528 · ATC

Active substance
Valganciclovir
Route of administration
ORAL
Max daily dose
900 mg milligram(s)
Max total dose
346500 mg milligram(s)
Max treatment duration
104 Week(s)
Authorisation status
Authorised
ATC code
J05AB14 — VALGANCICLOVIR
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Placebo tablets are produced with the same appearance as the Valganciclovir tablets, with the same content except for the active compound.

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska Institutet

27 Total trials 9 Recruiting 5 Ended
Academic / Non-commercial
Sponsor organisation
Karolinska Institutet
Address
Nobels Vag 6
City
Solna
Postcode
171 65
Country
Sweden

Scientific contact point

Organisation
Karolinska Institutet
Contact name
Cecilia Söderberg-Nauclér

Public contact point

Organisation
Karolinska Institutet
Contact name
Cecilia Söderberg-Nauclér

Locations

2 EU/EEA countries · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Norway Authorised, recruitment pending 30 2
Sweden Authorised, recruitment pending 190 1
Rest of world — 0 —

Investigational sites

Norway

2 sites · Authorised, recruitment pending
Oslo University Hospital HF
Department of Oncology, Taarnbygget, Kirkeveien 166, Oslo
Stavanger University Hospital HF
Department of Oncology, Helse Stavanger HF, Postboks 8100, Stavanger

Sweden

1 site · Authorised, recruitment pending
Karolinska University Hospital
Department of Neurology, Eugeniavagen 3, 171 64, Solna

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Study Protocol Appendices_2023-504846-73-01 1
Protocol (for publication) Study Protocol_2023-504846-73-01 8
Recruitment arrangements (for publication) CLINICAL TRIAL VIGAS2 Norway_2023-504846-73-01 1
Recruitment arrangements (for publication) CLINICAL TRIAL VIGAS2 ETIK_2023-504846-73-01 1
Recruitment arrangements (for publication) CLINICAL TRIAL VIGAS2 LMV_2023-504846-73-01 1
Subject information and informed consent form (for publication) Informed consent form Norway_2023-504846-73-01 1
Subject information and informed consent form (for publication) Informed consent form_2023-504846-73-01 3
Summary of Product Characteristics (SmPC) (for publication) SmPC_Valganciclovir 1
Synopsis of the protocol (for publication) Synopsis of Study Protocol_2023-504846-73-01 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-08 Sweden Acceptable
2024-10-28
 2024-10-29