Clinical trial • Phase III • Oncology|Neurology

Bevacizumab for Glioblastoma|Malignant glioma

Phase III trial of Bevacizumab for Glioblastoma|Malignant glioma.

Overview

Trial Therapeutic Area
Oncology|Neurology
Trial Disease
Glioblastoma|Malignant glioma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
10-12-2024
First CTIS Authorization Date
13-01-2025

Trial design

Randomised, open-label, comparator arm: lomustine monotherapy (lomustine medac 40 mg, capsule). experimental arm: lomustine plus bevacizumab (zirabev 25 mg/ml concentrate for solution for infusion). specific dose schedules not specified in the available data; product entries list lomustine max total dose 200 mg and bevacizumab dose unit mg/kg with max total amount 10 (mg/kg).-controlled Phase III trial across 4 sites in Denmark.

Randomised
Yes
Open Label
Yes
Comparator
Comparator arm: Lomustine monotherapy (LOMUSTINE MEDAC 40 mg, capsule). Experimental arm: Lomustine plus bevacizumab (Zirabev 25 mg/ml concentrate for solution for infusion). Specific dose schedules not specified in the available data; product entries list lomustine max total dose 200 mg and bevacizumab dose unit mg/kg with max total amount 10 (mg/kg).
Target Sample Size
168

Eligibility

Recruits 168 The trial does not select a vulnerable population (isVulnerablePopulationSelected: false). Adults only (Age > 18). Signed informed consent is required from participants (subject information and informed consent form available). No assent or under-18 consent procedures are indicated..

Vulnerable Population
The trial does not select a vulnerable population (isVulnerablePopulationSelected: false). Adults only (Age > 18). Signed informed consent is required from participants (subject information and informed consent form available). No assent or under-18 consent procedures are indicated.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent\n- Histological verified glioblastoma\n- Recurrent GBM, previously treated according the STUPP regimen\n- No more than one line of chemotherapy (concurrent and adjuvant temozolomide based chemotherapy including in combination with another investigational agent is considered one line of chemotherapy).\n- PS 0-1\n- Age > 18\n- Expected survival > 3 months\n- First progression after RT concurrent/adjuvant chemotherapy (STUPPS regimen). In case of early progression, then at least 3 months after termination of radiotherapy and at least 4 weeks after adjuvant chemotherapy.\n- No more than one line of chemotherapy"}

Exclusion criteria

  • {"criterion_text":"- Previous therapy of recurrent GBM including temozolomide reinduction.\n- Previous use of biological drug targeting the VEGF-signaling pathway\n- Concurrent use of medication that can affect the interpretation of the results from the study, e.g. use of immunosuppressive drugs, except corticosteroids\n- Conditions (medical, social or physical) that may compromise proper information and/or follow-up\n- Other concurrent or previous cancer within 5 years, except adequately treated basal or squamous cell skin cancer, or cervical carcinoma in situ"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is overall survival","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 1) To determine the 6- and 12 months progression-free survival (PFS)\n- 2) To determine the objective response rate (RR) and duration of response (according to RANO criteria).\n- 3) To determine the overall survival distribution and overall survival at 12 and 18 months.\n- 4) To determine the safety and feasibility of the combination of bevacizumab and lomustine as compared to lomustine alone.","definition_or_measurement_approach":"Secondary endpoints include PFS at 6 and 12 months; objective response rate and duration of response specified to be assessed according to RANO criteria; overall survival distribution and OS at 12 and 18 months; safety and feasibility comparisons between combination and lomustine alone."}

Recruitment

Planned Sample Size
168
Recruitment Window Months
72
Consent Approach
Signed informed consent is required from each participant. Subject information and informed consent form documents are listed for publication. Participants are adults (age > 18). No details on assent or multiple-language documents are provided.

Geography

Total Number Of Sites
4
Total Number Of Participants
168

Denmark

Earliest CTIS Part Ii Submission Date
02-01-2025
Latest Decision Or Authorization Date
13-01-2025
Processing Time Days
11
Number Of Sites
4
Number Of Participants
168

Sites

Site Name
Aarhus University Hospital
Department Name
Oncology
Principal Investigator Name
Slávka Lukacova
Principal Investigator Email
slavka.lukacova@auh.rm.dk
Contact Person Name
Slávka Lukacova
Contact Person Email
slavka.lukacova@auh.rm.dk
Site Name
Copenhagen University Hospital
Department Name
Oncology
Principal Investigator Name
Ulrik Lassen
Principal Investigator Email
ulrik.lassen@regionh.dk
Contact Person Name
Ulrik Lassen
Contact Person Email
ulrik.lassen@regionh.dk
Site Name
Aalborg University Hospital
Department Name
Oncology
Principal Investigator Name
Charlotte Haslund
Principal Investigator Email
cah@rn.dk
Contact Person Name
Charlotte Haslund
Contact Person Email
cah@rn.dk
Site Name
Odense University Hospital
Department Name
Oncology
Principal Investigator Name
Dahlrot Rikke
Principal Investigator Email
rikke.dahlrot@rsyd.dk
Contact Person Name
Dahlrot Rikke
Contact Person Email
rikke.dahlrot@rsyd.dk

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"The Danish GCP units","duties_or_roles":"sponsorDuties code 1; contact email: gcp-enheden.bispebjerg-frederiksberg-hospitaler@regionh.dk","organisation_type":"Health care"}
  • {"country":"","full_name":"Danish Regions","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Zirabev 25 mg/ml concentrate for solution for infusion.
Active Substance
Bevacizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Marketing authorisation info present (marketingAuthNumber: EU/1/18/1344/002)
Maximum Dose
10 mg/kg
Investigational Product Name
LOMUSTINE MEDAC 40 mg, gélule
Active Substance
Lomustine
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation info present (marketingAuthNumber: 34009 550 926 6 7)
Maximum Dose
200 mg
Combination Treatment
Yes

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