Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
41
Countries
1
Sites
3
Advanced melanoma
The project aims to prospectively evaluate the effect of anti-PD-1 antibodies alone or in combination with anti-CTLA-4 antibodies in patients with melanoma metastasized to the brain in need of steroid treatment
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Jun 2018 → ongoing
- Decision date (initial)
- 2024-08-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Danish Cancer Society
External identifiers
- EU CT number
- 2024-516585-11-00
- EudraCT number
- 2018-000875-34
- ClinicalTrials.gov
- NCT03563729
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The project aims to prospectively evaluate the effect of anti-PD-1 antibodies alone or in combination with anti-CTLA-4 antibodies in patients with melanoma metastasized to the brain in need of steroid treatment
Conditions and MedDRA coding
Advanced melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10025655 | Malignant melanoma of skin | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Histologically confirmed metastatic melanoma with radiologically verified brain metastasis
- Need for systemic steroid treatment (prednisolone > 10 mg daily; dexamethasone > 1.6 mg daily, hydrocortisone > 40 mg daily or equivalent) due to brain metastasis
- At least one measurable lesion according to RECIST version 1.1 guidelines
- ≥ 18 years of age
- Performance status 0-2
- Able to undergo MRI with gadolinium contrast agent
- Adequate hematological and organ function
- Signed statement of consent after receiving oral and written study information
Exclusion criteria 8
- Another malignancy or concurrent malignancy unless disease-free for 3 years
- Ocular melanoma
- Known hypersensitivity to one of the active drugs or excipients
- Acute or chronic infections with HIV or hepatitis
- Any medical condition that will interfere with patient compliance or safety
- Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the metastatic setting
- Prior systemic treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the adjuvant setting, unless completed more than 6 months before enrolment in this study
- Simultaneous treatment with other experimental drugs or other anticancer drugs
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 6 months progression-free survival rate
- 6 months overall survival rate
Secondary endpoints 7
- Overall progression-free survival
- Overall survival
- Overall response rate according to modified RECIST 1.1
- Extracranial response rate in extracranial lesions according to modified RECIST 1.1
- Intracranial response rate in intracranial lesions according to modified RECIST 1.1
- Intracranial clinical benefit rate (CR+PR+SD) – proportion of patients with an overall complete, partial response or stable disease ≥ 6 months according to modified RECIST 1.1
- Blood and tissue biomarkers of response and progression
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941372 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 12480 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 400 mg/Kg milligram(s)/kilogram
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB45696 · Substance
- Active substance
- Dabrafenib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 8400 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB119776 · Substance
- Active substance
- Trametinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 56 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
YERVOY 5 mg/ml concentrate for solution for infusion
PRD2341715 · Product
- Active substance
- Ipilimumab
- Substance synonyms
- BMS734016, HLX13, IBI310
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 3 mg/Kg milligram(s)/kilogram
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FX04 — -
- Marketing authorisation
- EU/1/11/698/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB177218 · Substance
- Active substance
- Encorafenib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 450 mg milligram(s)
- Max total dose
- 12600 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB179942 · Substance
- Active substance
- Binimetinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Borgmester Ib Juuls Vej 1
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Troels Holz Borch
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Troels Holz Borch
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 41 | 3 |
| 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 | 2018-06-12 | 2018-08-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516585-11-00 | 1.7 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF 2024-516585-11-00 | 1.8 |
| Subject information and informed consent form (for publication) | L2_Information leaflet for participants in clinical trials 10May2023 | 1 |
| Subject information and informed consent form (for publication) | L2_Right to not know consent form v1 1Apr 2026 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Binimetinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dabrafenib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Encorafenib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ipilimumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pembrolizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Trametinib | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-516585-11-00 DK | 1.2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-13 | Denmark | Acceptable 2024-08-26
|
2024-08-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-27 | Denmark | Acceptable 2026-04-23
|
2026-05-07 |