Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
96
Countries
1
Sites
2
Melanoma
To evaluate clinical performance of IOpener-melanoma in patients where standard of care treatment selection is based on IOpener-melanoma test result
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 14 Jan 2026 → ongoing
- Decision date (initial)
- 2025-07-25
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Pamgene
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate clinical performance of IOpener-melanoma in patients where standard of care treatment selection is based on IOpener-melanoma test result
Secondary objectives 2
- to evaluate clinical predictive performance (sensitivity, specificity, PPV, NPV) of IOpener-melanoma test for DCR, ORR, PFS and OS
- To establish clinical utility of IOpener-melanoma test by performing health economic impact analysis
Conditions and MedDRA coding
Melanoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Unresectable stage III or stage IV cutaneous melanoma for whom treatment with immune checkpoint inhibitors (ICIs) is considered by the treating physician.
- Inclusion of patients with brain metastases is permitted if the metastases are asymptomatic or have been treated.
- Anticipated life expectancy exceeding 3 months.
- Aged 18 years or older and written informed consent for participation in the study.
Exclusion criteria 9
- Prior treatment for irresectable stage III or stage IV melanoma with BRAF/MEK inhibitors or immunotherapy
- Serum LDH >2x ULN.
- Presence of symptomatic brain metastases
- WHO performance score > 2.
- (Neo)adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months.
- Patients undergoing other experimental treatments or therapies that may interfere with the immunotherapy's mechanism of action or assessment of its effects might be excluded.
- Pregnant, lactating, or breast-feeding women.
- Presence of any medical or other conditiën that in the opinion of the investigator(s) would preclude the participation in a clinical study.
- Unwillingness or inability to comply with study and follow-up procedures
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • 1-Year PFS (proportion of patients with Progression Free Survival ^ 1 year)
Secondary endpoints 5
- Disease Control Rate (DCR, "clinical benefit”), based on Best Overall Response according to RECIST 1.1
- overal response Rate (ORR) based on Best Overall Response according tot RECIST 1.1
- overall survival (OS) and progression free survial (PFS)
- Quality of Life (QoL) using EQ-5D-5L
- Medical Costs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SCP6094344 · ATC
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 6800 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — PEMBROLIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP759188 · ATC
- Route of administration
- INFUSION
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 12 mg/kg milligram(s)/kilogram
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FX04 — IPILIMUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP8265340 · ATC
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 4 mg/kg milligram(s)/kilogram
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — NIVOLUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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
- H.W. Kapiteijn
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- H.W. Kapiteijn
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 96 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2026-01-14 | 2026-01-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol | 1.4 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main not for publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC keytruda | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC opdivo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC yervoy | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis 2025-520913-29-00 NL | 1.4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-16 | Netherlands | Acceptable 2025-07-25
|
2025-07-25 |