Overview
Sponsor-declared trial summary
Malignant melanoma
The overall aim of the study is to evaluate Total Body (TB) positron emission tomography/computed tomography (PET/CT) combined with the tracer [68Ga]Ga-FAPI-46 for response evaluation during immune checkpoint inhibitor therapy (ICT) in patients with advanced stage malignant melanoma.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 3 Aug 2025 → ongoing
- Decision date (initial)
- 2025-03-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
The overall aim of the study is to evaluate Total Body (TB) positron emission tomography/computed tomography (PET/CT) combined with the tracer [68Ga]Ga-FAPI-46 for response evaluation during immune checkpoint inhibitor therapy (ICT) in patients with advanced stage malignant melanoma.
Conditions and MedDRA coding
Malignant melanoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male or female, > 18 years old
- Histological verified metastatic or locally advanced malignant melanoma
- Visible malignant lesions on [18F]FDG PET/CT or CT
- Subjects must be considered medically suitable for ICT (either Pembrolizumab or Ipilimumab+Nivolumab)
- Subjects must be able to read and understand the patient information in Danish to give informed consent
Exclusion criteria 5
- Ocular or mucosal melanoma
- Other concurrent cancer disease
- Pregnancy or lactation
- Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
- History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Evaluate [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT.
- Evaluate changes in [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT.
- Compare the changes in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT with changes on standard [18F]FDG PET/CT and clinical response during ICT.
Secondary endpoints 5
- Changes in [68Ga]Ga-FAPI-46 uptake during ICT in healthy tissue as a predictor of potential side effects.
- Compare changes on [68Ga]Ga-FAPI-46 PET/CT in healthy tissue with changes on standard [18F]FDG PET/CT.
- Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of FAP activity biomarkers in serum blood samples.
- Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of other biomarkers (e.g. ECM remodeling biomarkers) in serum blood samples.
- Correlation between levels of biomarkers in serum blood samples and treatment outcome.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10114365 · Product
- Active substance
- (S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 246 MBq megabecquerel(s)
- Max total dose
- 246 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- RHPET
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Fluor-18-FDG, 400 MBq-210 GBq, injektionsvreske Fludeoxyglucose (18F)
PRD3209304 · Product
- Active substance
- Fludeoxyglucose (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 400 MBq megabecquerel(s)
- Max total dose
- 400 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX04 — -
- Marketing authorisation
- DK R 14
- MA holder
- CYKLOTRON & RADIOCHEMISTRY, UNIT 3982, RIGSHOSPITALET
- MA country
- Denmark
- 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
- Barbara Malene Fischer
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Barbara Malene Fischer
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 20 | 2 |
| 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 |
|---|---|---|---|---|---|
| Denmark | 2025-08-03 | 2025-08-15 |
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_2023-509549-11-00_BEFAST_MM_redacted | 4 |
| Recruitment arrangements (for publication) | Recruitment arrangements_BEFAST_MM | 3 |
| Subject information and informed consent form (for publication) | SI_ICF_BEFAST_MM_redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | Fluor18FDG_radioaktivinjektionsvske_BEFAST_MM | 1 |
| Synopsis of the protocol (for publication) | Protocolsynopsis_ENG_2023-509549-11-00_BEFAST_MM | 2 |
| Synopsis of the protocol (for publication) | Protokolsynopsis_DK_2023-509549-11-00_BEFAST_mm | 4 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-27 | Denmark | Acceptable 2025-03-04
|
2025-03-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-02 | Denmark | Acceptable 2025-03-04
|
2025-06-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-21 | Denmark | Acceptable 2026-05-12
|
2026-05-13 |