Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
168
Countries
1
Sites
4
Glioblastoma
The primary endpoint is overall survival
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Feb 2025 → ongoing
- Decision date (initial)
- 2025-01-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Danish Regions · Danish Regions
External identifiers
- EU CT number
- 2024-519437-27-02
- EudraCT number
- 2020-003545-11
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The primary endpoint is overall survival
Secondary objectives 1
- safety
Conditions and MedDRA coding
Glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10065443 | Malignant glioma | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A randomized phase III trial with lomustine versus lomustine and bevacizumab Randomized trial in recurrent glioblastoma
|
Randomised Controlled | None | Lomustine: Lomustine monotherapy as standard arm Lomusine plus bevacizumab: Experimental arm |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519437-27-00 | A randomized phase III trial with lomustine versus lomustine and bevacizumab for patients with recurrent glioblastoma | Rigshospitalet |
| 2024-519094-19-00 | A randomized phase III trial with lomustine versus lomustine and bevacizumab for patients with recurrent glioblastoma | Rigshospitalet |
| 2024-517461-16-01 | A randomized phase III trial with lomustine versus lomustine and bevacizumab for patients with recurrent glioblastoma | Rigshospitalet |
| 2024-519437-27-01 | A randomized phase III trial with lomustine versus lomustine and bevacizumab for patients with recurrent glioblastoma | Rigshospitalet |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Signed informed consent • Histological verified glioblastoma • Recurrent GBM, previously treated according the STUPP regimen • 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). • PS 0-1 • Age > 18 • Expected survival > 3 months • 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. • No more than one line of chemotherapy
Exclusion criteria 1
- • Previous therapy of recurrent GBM including temozolomide reinduction. • Previous use of biological drug targeting the VEGF-signaling pathway • Concurrent use of medication that can affect the interpretation of the results from the study, e.g. use of immunosuppressive drugs, except corticosteroids • Conditions (medical, social or physical) that may compromise proper information and/or follow-up • Other concurrent or previous cancer within 5 years, except adequately treated basal or squamous cell skin cancer, or cervical carcinoma in situ
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is overall survival
Secondary endpoints 1
- 1) To determine the 6- and 12 months progression-free survival (PFS) 2) To determine the objective response rate (RR) and duration of response (according to RANO criteria). 3) To determine the overall survival distribution and overall survival at 12 and 18 months. 4) To determine the safety and feasibility of the combination of bevacizumab and lomustine as compared to lomustine alone.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Zirabev 25 mg/ml concentrate for solution for infusion.
PRD7082677 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 10 mg/Kg milligram(s)/kilogram
- Max total dose
- 10 mg/kg milligram(s)/kilogram
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/18/1344/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD10510095 · Product
- Active substance
- Lomustine
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AD02 — LOMUSTINE
- Marketing authorisation
- 34009 550 926 6 7
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Ulrik Lassen
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Ulrik Lassen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| The Danish GCP units ORL-000010299
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 168 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Aarhus University Hospital
Oncology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Aalborg University Hospital
Oncology, Hobrovej 18-22, 9000, Aalborg
Odense University Hospital
Oncology, J B Winsloews Vej 4, 5000, Odense C
Copenhagen University Hospital
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-02-03 | 2025-02-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol-DNOG-LOBE | 1 |
| Recruitment arrangements (for publication) | Recruitment | 1 |
| Subject information and informed consent form (for publication) | Detagerinformation LOBE | 1 |
| Subject information and informed consent form (for publication) | Informeret samtykke LOBE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Lomustine_medac-spc-common | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | zirabev-epar-product-information_en | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-10 | Denmark | Acceptable 2025-01-13
|
2025-01-13 |