Overview
Sponsor-declared trial summary
NF2-related schwannomatosis
To validate pre-treatment [89Zr]-bevacizumab PET/CT as an imaging biomarker for prediction of a hearing response to bevacizumab treatment in patients with NF2 related (vestibular) schwannomas.
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- 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], Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Trial duration
- 1 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512860-75-00
- EudraCT number
- 2020-000156-35
- ClinicalTrials.gov
- NCT05685836
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To validate pre-treatment [89Zr]-bevacizumab PET/CT as an imaging biomarker for prediction of a hearing response to bevacizumab treatment in patients with NF2 related (vestibular) schwannomas.
Conditions and MedDRA coding
NF2-related schwannomatosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients aged 18 years or older
- Confirmed diagnosis of NF2 by revised Manchester criteria (appendix C)
- Provided written informed consent
- Patients must have measurable disease, defined as at least one VS > 0.4 ml (on volumetric analysis) that can be accurately measured by contrast-enhanced T1- weighted cranial MRI scan
- Eligible and planned for bevacizumab treatment
Exclusion criteria 3
- Patients with a contra-indication for PET and MRI, such as pregnancy and metal elements.
- Patients with a known allergy to substances used in this study
- Concurrent treatment with Everolimus
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The correlation of the results of the pre-treatment 89Zr- Bevacizumab with the proportion of patients with confirmed hearing response (HR) and radiographic response (RR) to bevacizumab therapy.
Secondary endpoints 1
- Correlations of pre-treatment 89Zr-Bevacizumab PET/CT imaging with patient-reported outcome measures (PROM), vestibular function, cranial nerve (dys)function, kidney function and nontarget schwannoma response after bevacizumab treatment in NF2-patients.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11541607 · Product
- Active substance
- Bevacizumab Zirconium ZR-89
- Substance synonyms
- 89ZR-BEVACIZUMAB
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AMSTERDAM UMC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Prof.dr. A.J. Gelderblom
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Prof.dr. A.J. Gelderblom
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-10-01 | 2024-10-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-512860-75-00_Redacted | 3 |
| Recruitment arrangements (for publication) | K1 recruitement arrangements Blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_IB Appendix B - Avastin EPAR Product Information_SmPC | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-12 | Netherlands | Acceptable with conditions 2024-10-01
|
2024-10-01 |