Overview
Sponsor-declared trial summary
Melanoma
To assess the relative change in uptake of [18F]F-AraG in tumor lesions upon radiotherapy.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Boehringer Ingelheim
External identifiers
- EU CT number
- 2024-517960-45-00
- EudraCT number
- 2021-003986-36
- ClinicalTrials.gov
- NCT05701176
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To assess the relative change in uptake of [18F]F-AraG in tumor lesions upon radiotherapy.
Conditions and MedDRA coding
Melanoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Histologically confirmed NSCLC, melanoma, esophageal, or breast cancer • Ongoing immunotherapy using an anti-PD-(L)1 agent • Planned to be treated with high dose (24Gy) radiotherapy per clinical indication • Be willing and able to provide written informed consent for the trial. • Have a performance status of 0-2 on the ECOG Performance Scale • Be above 18 years of age on day of signing informed consent.
Exclusion criteria 1
- • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. • Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. • Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last administration of [ 18F]F-AraG.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To assess the relative change in uptake of [18F]F-AraG in tumor lesions on anti-PD-1 treatment. i. To define tracer uptake in all tumor lesions and lymphoid organs (lymph nodes, spleen) per [ 18F]F-AraG PET scan using the optimized simplified uptake parameter (SUV, TBR, TPR). ii. To assess the changes in uptake between baseline and after 1 and 3 weeks post-RT, respectively.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB09188MIG · Substance
- Active substance
- Nelarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Modified into radiopharmaceutical tracer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Idris Bahce
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Idris Bahce
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 12 | 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 | 2024-10-02 | 2024-10-02 |
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) | C1_Study protocol_SHARP | 2.1 |
| Recruitment arrangements (for publication) | This aspect was assessed by National Competent Authority | 1 |
| Subject information and informed consent form (for publication) | E1_E2_Proefpersoneninformatiebrief_SHARP | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | Not Applicable | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-23 | Netherlands | Acceptable with conditions 2024-10-02
|
2024-10-02 |