Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
472
Countries
10
Sites
75
Unresectable or metastatic NRAS mutant cutaneous melanoma
Stage 1 (Dose Optimization) - To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 Stage 2 (Registration-Enabling Portion) - To compare PFS and overall survival (OS) for patients with NRASm melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients…
Key facts
- Sponsor
- Erasca Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Oct 2024 → ongoing
- Decision date (initial)
- 2024-09-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511404-17-00
- ClinicalTrials.gov
- NCT06346067
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacokinetic, Safety, Therapy, Efficacy, Pharmacogenomic
Stage 1 (Dose Optimization) - To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Stage 2 (Registration-Enabling Portion) - To compare PFS and overall survival (OS) for patients with NRASm melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician’s choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy)
Secondary objectives 8
- Stage 1 (Dose Optimization) - To evaluate the preliminary clinical activity of naporafenib + trametinib (administered at 2 dose regimens) or trametinib monotherapy in patients with neuroblastoma rat sarcoma mutant (NRASm) melanoma
- Stage 1 (Dose Optimization) - To evaluate the safety and tolerability of naporafenib + trametinib (administered at 2 dose regimens) or trametinib monotherapy in patients with NRASm melanoma
- Stage 1 (Dose Optimization) - To evaluate the PK of naporafenib and trametinib when administered as combination therapy (administered at 2 dose regimens) and the PK of trametinib when administered as monotherapy in patients with NRASm melanoma
- Stage 2 (Registration-Enabling Portion) - To compare measures of clinical activity for patients with NRASm melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician’s choice of therapy
- Stage 2 (Registration-Enabling Portion) - To evaluate the safety and tolerability for patients with NRASm melanoma in each treatment arm
- Stage 2 (Registration-Enabling Portion) - To further compare measures of clinical activity for patients with NRASm melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician’s choice of therapy
- Stage 2 (Registration-Enabling Portion) - To evaluate the PK of naporafenib + trametinib as combination therapy when administered to patients with NRASm melanoma
- Stage 2 (Registration-Enabling Portion) - To assess disease and treatment-related QOL in patients with NRASm melanoma receiving either naporafenib + trametinib or physician’s choice of therapy
Conditions and MedDRA coding
Unresectable or metastatic NRAS mutant cutaneous melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088049 | Cutaneous melanoma | 100000004848 |
Regulatory references
- Scientific advice from competent authorities
- Swedish Medical Products Agency, Medicines And Healthcare Products Regulatory Agency, European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Patient has voluntarily agreed to participate by giving written informed consent in accordance with International Council for Harmonization (ICH)/GCP guidelines and applicable local regulations
- Age ≥ 18 years
- Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma
- Documentation of an NRAS mutation (tumor tissue or blood) prior to first dose of study drug(s) as determined locally with an analytically validated assay in a certified testing laboratory.
- Archival tumor tissue collected within 5 years prior to enrollment must be confirmed to be available at the time of Screening, which may be submitted before or after enrollment for exploratory biomarker analysis.
- Must have received an anti-PD-1/L1 based regimen (monotherapy or combination). Patient must have documented disease progression either while receiving therapy or within 12 weeks of last dose of the most recent anti-PD-1/L1 based regimen; the patient is eligible if they have received other therapies between the most recent anti-PD-1/L1 based regimen and enrollment.
- ECOG performance status 0, 1 or 2
- Presence of at least 1 measurable lesion according to RECIST v1.1
- Able to swallow oral medication.
Exclusion criteria 8
- Patients with uveal or mucosal melanoma
- Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome)
- LVEF <50%
- Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible.
- Patients receiving treatment with herbal medicine known to cause liver toxicity, which cannot be discontinued 7 days prior to first dose of study drug(s) and for the duration of the study.
- Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Stage 1 (Dose Optimization) - Analysis of the totality of the safety, pharmacokinetics (PK), and preliminary efficacy data including exposure response relationships for tolerability, safety, and efficacy from Stage 1 and throughout the naporafenib program
- Stage 2 (Registration-Enabling Portion) - PFS using RECIST v1.1 per blinded independent central review (BICR)
- Stage 2 (Registration-Enabling Portion) - OS
Secondary endpoints 8
- Stage 1 (Dose Optimization) - Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: • Objective response rate (ORR) • Disease control rate (DCR) • Duration of response (DOR) • Progression-free survival (PFS) • Time to response (TTR)
- Stage 1 (Dose Optimization) - Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE), changes from baseline in laboratory values, vital signs, and cardiac assessments (electrocardiogram [ECG], echocardiogram [ECHO]/multigated acquisition [MUGA]) Tolerability: AEs leading to dose interruptions, reductions, and permanent discontinuation of study drug(s)
- Stage 1 (Dose Optimization) - Plasma concentrations of naporafenib and trametinib as combination therapy and plasma concentrations of trametinib as monotherapy obtained via sparse sampling for population PK modeling
- Stage 2 (Registration-Enabling Portion) - Using RECIST v1.1, per BICR: • ORR • DOR
- Stage 2 (Registration-Enabling Portion) - Safety: Incidence and severity of AEs and SAEs, changes from baseline in laboratory values, vital signs, and cardiac assessments (ECG, ECHO/ MUGA) Tolerability: AEs leading to dose interruptions, reductions, and permanent discontinuation of study drug(s)
- Stage 2 (Registration-Enabling Portion) - Using RECIST v1.1, per investigator assessment: • PFS • ORR • DOR • DCR • TTR
- Stage 2 (Registration-Enabling Portion) - Plasma concentrations of naporafenib and trametinib as combination therapy obtained via sparse sampling for population PK modeling
- Stage 2 (Registration-Enabling Portion) - Change from baseline in: • EORTC QLQ-C30 subscales • PRO CTCAE® symptoms Change from baseline to landmark timepoint(s) for one or more of the above measures; specific endpoints of interest will be selected based on data from Stage 1 and prespecified before initiating Stage 2.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
Mekinist 0.5 mg film-coated tablets
PRD3045763 · Product
- Active substance
- Trametinib
- Substance synonyms
- GSK1120212B
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EE01 — -
- Marketing authorisation
- EU/1/14/931/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Mekinist ® will be provided in a packaging configuration specific for clinical trials use. Information pertaining to the manufacturing sites involved in the labeling, importation, and release of trametinib is provided in the study specific sIMPD for Trametinib Tablets, Version 1.0 dated 15Apr2024.
Mekinist 0.5 mg film-coated tablets
PRD3045762 · Product
- Active substance
- Trametinib
- Substance synonyms
- GSK1120212B
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EE01 — -
- Marketing authorisation
- EU/1/14/931/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Mekinist ® will be provided in a packaging configuration specific for clinical trials use. Information pertaining to the manufacturing sites involved in the labeling, importation, and release of trametinib is provided in the study specific sIMPD for Trametinib Tablets, Version 1.0 dated 15Apr2024.
PRD11389864 · Product
- Active substance
- Naporafenib
- Substance synonyms
- LXH254, LXH-254, N-{3-[2-(2-HYDROXYETHOXY)-6-(MORPHOLIN-4-YL)PYRIDIN-4-YL]-4-METHYLPHENYL}-2-(TRIFLUOROMETHYL)PYRIDINE-4-CARBOXAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ERASCA, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11389867 · Product
- Active substance
- Naporafenib
- Substance synonyms
- LXH254, LXH-254, N-{3-[2-(2-HYDROXYETHOXY)-6-(MORPHOLIN-4-YL)PYRIDIN-4-YL]-4-METHYLPHENYL}-2-(TRIFLUOROMETHYL)PYRIDINE-4-CARBOXAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ERASCA, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11213777 · Product
- Active substance
- Naporafenib
- Substance synonyms
- LXH254, LXH-254, N-{3-[2-(2-HYDROXYETHOXY)-6-(MORPHOLIN-4-YL)PYRIDIN-4-YL]-4-METHYLPHENYL}-2-(TRIFLUOROMETHYL)PYRIDINE-4-CARBOXAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ERASCA, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11389873 · Product
- Active substance
- Naporafenib
- Substance synonyms
- LXH254, LXH-254, N-{3-[2-(2-HYDROXYETHOXY)-6-(MORPHOLIN-4-YL)PYRIDIN-4-YL]-4-METHYLPHENYL}-2-(TRIFLUOROMETHYL)PYRIDINE-4-CARBOXAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ERASCA, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 8
Dacarbazine medac 1000 mg, powder for solution for infusion
PRD507001 · Product
- Active substance
- Dacarbazine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 1000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AX04 — DACARBAZINE
- Marketing authorisation
- PL 11587/0011
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dacarbazine medac 100 mg, powder for solution for injection/infusion
PRD503796 · Product
- Active substance
- Dacarbazine Citrate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 1000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AX04 — DACARBAZINE
- Marketing authorisation
- PL 11587/0008
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dacarbazine medac 200 mg, powder for solution for injection/infusion
PRD504674 · Product
- Active substance
- Dacarbazine
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 1000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AX04 — DACARBAZINE
- Marketing authorisation
- PL 11587/0009
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dacarbazine medac 500 mg, powder for solution for infusion
PRD505257 · Product
- Active substance
- Dacarbazine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 1000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AX04 — DACARBAZINE
- Marketing authorisation
- PL 11587/0010
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Temomedac 100 mg hard capsules
PRD3244766 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/09/605/005
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3244772 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/09/605/004
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Temomedac 100 mg hard capsules
PRD3244765 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/09/605/006
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3244771 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/09/605/003
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
PRD3120808 · Product
- Active substance
- Hydrocortisone
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 28 g gram(s)
- Max total dose
- 28 g gram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- D07AA02 — HYDROCORTISONE
- Marketing authorisation
- PA 206/30/1
- MA holder
- OVELLE LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Doxy-M-ratiopharm® 100 mg Tabletten
PRD657157 · Product
- Active substance
- Doxycycline Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01AA02 — DOXYCYCLINE
- Marketing authorisation
- 16390.00.00
- MA holder
- RATIOPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasca Inc.
- Sponsor organisation
- Erasca Inc.
- Address
- 10835 Road To The Cure Suite 140
- City
- San Diego
- Postcode
- 92121-1130
- Country
- United States
Scientific contact point
- Organisation
- Erasca Inc.
- Contact name
- Vice President, Clinical Operations
Public contact point
- Organisation
- Erasca Inc.
- Contact name
- Vice President, Clinical Operations
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Allucent (NL) B.V. ORG-100027147
|
Schiphol, Netherlands | Other |
Locations
10 EU/EEA countries · 75 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 16 | 3 |
| Czechia | Ended | 20 | 5 |
| Denmark | Ended | 12 | 3 |
| France | Ended | 52 | 13 |
| Germany | Ended | 60 | 17 |
| Italy | Ongoing, recruitment ended | 50 | 13 |
| Netherlands | Ended | 28 | 7 |
| Norway | Ended | 12 | 3 |
| Spain | Ended | 36 | 9 |
| Sweden | Ended | 8 | 2 |
| Rest of world
Switzerland, Australia, United States, United Kingdom
|
— | 178 | — |
Investigational sites
Universitair Ziekenhuis Gent
Oncology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Brussel
Oncology, Laarbeeklaan 101, 1090, Jette
Sanatorium profesora Arenbergera
Dermatology, Bolzanova 7, 110 00 Praha 1, Prague
Masarykuv Onkologicky Ustav
Clinical Oncology, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Vseobecna Fakultni Nemocnice V Praze
Dermatovenerology, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Hradec Kralove
Oncology and Radiotherapy, Sokolska 581, 500 03, Novy Hradec Kralove
University Hospital Olomouc
Oncology, Zdravotniku 248/7, 779 00, Olomouc
Region Hovedstaden
Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Aalborg University Hospital
Oncology, Hobrovej 18-22, 9000, Aalborg
Aarhus Universitetshospital
Oncology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre De Lutte Contre Le Cancer Eugene Marquis
Medical Oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Assistance Publique Hopitaux De Paris
Dermatology, 9 Avenue Charles De Gaulle, 92100, Boulogne-Billancourt
Hospices Civils De Lyon
Dermatology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut Gustave Roussy
Dermatology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional De Marseille
Dermatology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Bordeaux
Dermatology, 1 Rue Jean Burguet, 33000, Bordeaux
Hopital Saint Louis
Dermatology, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Dijon
Dermatology, 14 Rue Paul Gaffarel, 21000, Dijon
University Hospital Of Clermont-Ferrand
Dermatology -Venerology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Universitaire De Nice
Dermatology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Le Mans
Dermatology, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Universitaire De Caen Normandie
Dermatology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Lille
Dermatology, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Otto Von Guericke Universitaet Magdeburg
Dermatology, Leipziger Strasse 44, Leipziger Str., Magdeburg
Universitaetsklinikum Tuebingen AöR
Dermatology, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Universitaetsklinikum Schleswig-Holstein AöR
Dermatology, Arnold-Heller-Strasse 3, Brunswik, Kiel
Klinikum der Universitaet Muenchen AöR
Dermatology and allergology, Frauenlobstrasse 9-11, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsmedizin Goettingen
Dermatology, Robert-Koch-Strasse 40, Weende, Goettingen
Universitat Heidelberg
Dermato-oncology, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Schleswig-Holstein AöR
Dermatology, Ratzeburger Allee 160, 23538, Luebeck
Fachklinik Hornheide e.V.
Oncology, Dorbaumstrasse 300, Handorf, Muenster
Universitaetsklinikum Erlangen AöR
Dermatology, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Dermatology, Langenbeckstrasse 1, Oberstadt, Mainz
Charite Universitaetsmedizin Berlin KöR
Dermatology, Chariteplatz 1, Mitte, Berlin
Medical Center - University Of Freiburg
Dermatology, Hauptstrasse 7, Herdern, Freiburg Im Breisgau
Gesundheit Nord gGmbH Klinikverbund Bremen
Dermatology and allergology, Zuericher Strasse 40, Ellenerbrok-Schevemoor, Bremen
Technische Universitaet Dresden
Dermatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Muehlenkreiskliniken AöR
Dermatology, allergology and venerology, Hans-Nolte-Strasse 1, Haeverstaedt, Minden
Medizinische Hochschule Hannover
Dermatology, allergology and venerology, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaet Leipzig
Dermatology, Philipp-Rosenthal-Strasse 23, Zentrum-Suedost, Leipzig
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Senese
Oncologic inmunotherapy, Strada Delle Scotte 14, 53100, Siena
Azienda Ospedaliero Universitaria Di Modena
Oncology and Hematology, Largo Del Pozzo 71, 41124, Modena
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology, Via Mariano Semmola 52, 80131, Naples
Azienda Sanitaria Universitaria Friuli Centrale
Oncology, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Ospedale San Raffaele S.r.l.
Oncology, Via Olgettina 60, 20132, Milan
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Fondazione Luigi Maria Monti
Oncology and Dermato-Oncology, Roma, Via Dei Monti Di Creta 104, Rome
Istituto Tumori Bari Giovanni Paolo II
Rare tumours and melanoma, Viale Orazio Flacco 65, 70124, Bari
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
I.F.O. Istituti Fisioterapici Ospitalieri
Sarcome and rare tumor, Via Elio Chianesi N 53, 00144, Rome
Hospital Santa Maria Della Misericordia
Oncology, Piazzale Giorgio Menghini 1, 06129, Perugia
Fondazione IRCCS San Gerardo Dei Tintori
Oncology, Via Giovanni Battista Pergolesi 33, 20900, Monza
Medisch Centrum Leeuwarden B.V.
Internal medicine, Henri Dunantweg 2, 8934 AD, Leeuwarden
Academisch Ziekenhuis Maastricht
Oncology, P Debyelaan 25, 6229 HX, Maastricht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Oncology and Radiology and Nuclear Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Leids Universitair Medisch Centrum (LUMC)
Oncology, Albinusdreef 2, 2333 ZA, Leiden
Isala Klinieken Stichting
Oncology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Stichting Amsterdam UMC
Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Radboud universitair medisch centrum / RADBOUDUMC
Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Akershus University Hospital
Oncology, Sykehusveien 25, 1474, Loerenskog
Helse Stavanger HF
Oncology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Oslo University Hospital HF
Oncology, Taarnbygget, Kirkeveien 166, Oslo
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Central De Asturias
Oncology, Avenida De Roma S/n, 33011, Oviedo
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 |
|---|---|---|---|---|---|
| Czechia | 2024-10-29 | ||||
| France | 2024-10-07 | 2024-10-22 | 2025-01-15 | ||
| Italy | 2024-12-04 | 2024-12-12 | 2025-01-15 | ||
| Netherlands | 2024-10-07 | 2024-10-28 | 2025-01-15 | ||
| Spain | 2024-10-29 | 2024-12-11 | 2025-01-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 133 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-511404-17-00_For publication | 2.1 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_BE-FR_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_BE-NL_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_CZ-CZ_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_DE-DE_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_DK-DA_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_EN_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_ES-ES_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_FR-FR_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_IT-IT_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_NL-NL_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_NO-NO_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_EORTC QLQ-C30 eCOA_SE-SV_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_BE-FR_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_BE-NL_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_CZ-CZ_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_DE-DE_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_DK-DA_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_EN_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_ES-ES_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_FR-FR_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_IT-IT_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_NL-NL_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_NO-NO_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_PRO CTCAE eCOA_SE-SE_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_BE-FR_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_BE-NL_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_CZ-CZ_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_DE-DE_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_DK-DA_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_EN_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_ES-ES_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_FR-FR_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_IT-IT_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_NL-NL_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_NO-NO_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module eCOA_SE-SV_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_BE-FR_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_BE-NL_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_CZ-CZ_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_DE-DE_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_DK-DA_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_EN_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_ES-ES_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_FR-FR_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_IT-IT_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_NL-NL_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_NO-NO_For publication | 1.0 |
| Protocol (for publication) | D3_Patient facing documents_TB Training Module Optional eCOA_SE-SV_For publication | 1.0 |
| Recruitment arrangements (for publication) | K1_DE_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_FR_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_IT_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrengements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrengements | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Main_For publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Pregnant Partner and Pregnant Participant_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Treatment Beyond Progression_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Advarra_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Main_For publication | 4.2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Pregnant partner_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Treatment Beyond Progression_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_FR_Other subject information material_Emergency card_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS and ICF_Advarra Longboat_For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS and ICF_IT_Pregnant_for publication | 1 |
| Subject information and informed consent form (for publication) | L1_IT_SIS and ICF_Main_for publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS and ICF_Progression_for publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Advarra Longboad ICF_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future research_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Longboat_ICF_for publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Stage 1_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF stage 2_For publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Stage 2_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Stage 1_For publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner and pregnancy follow-up_For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Progression_for publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Use of photographs_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_DE_Other subject information material_Participant Emergency ID Card | 1 |
| Subject information and informed consent form (for publication) | L2_DE_Other subject information_Advarra Privacy Policy_For publication | NA |
| Subject information and informed consent form (for publication) | L2_DE_Other subject information_Consent Navigator_For publication | 2 |
| Subject information and informed consent form (for publication) | L2_DE_Other subject information_Patient Portal_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_FR_Main ICF France_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L2_FR_Other subject information material_Patient note_For publication | 1.4 |
| Subject information and informed consent form (for publication) | L2_FR_SIS and ICF_Beyond Progression_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_FR_SIS and ICF_Future research_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_FR_SIS and ICF_Pregnant Partner and Pregnant Participant_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_FR_SIS and ICF_Use of photographs_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_IT_Other subject information material description_Participant Emergency ID Card-For publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other information given to subjects_Advarra Longboat Privacy Policy_For publication | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Advarra Longboat Consent Navigator_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Advarra Longboat Patient Portal_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Consent Navigator_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient portal_For publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Advarra Privacy Policy | NA |
| Subject information and informed consent form (for publication) | L2_Participant Emergency ID Card_ES_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_Participant Emergency ID Card_for publication | 1 |
| Subject information and informed consent form (for publication) | L3_IT_Other subject information material _GP letter-For publication | 1 |
| Subject information and informed consent form (for publication) | L3_Supplemental Dosing Instructions Napo Trame__For publication | 1 |
| Subject information and informed consent form (for publication) | L3_Supplemental Dosing Instructions Temozolomide_For publication | 1 |
| Subject information and informed consent form (for publication) | L3_Supplemental Dosing Instructions Trame_For publication | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_No SmPC_memo_Naporafenib_For publication | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dacarbazine_For publication | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Temomedac Temozolomide_For publication | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Trametinib Mekinist_For publication | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_BE-DE_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_BE-FR_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_BE-NL_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_CZ-CZ_For publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_DE-DE_For publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_DK-DA_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_EN_For publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_ES-ES_For publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_FR-FR_For publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_IT-IT_For publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_NL-NL_For publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_NO-NO_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Short Summary_2024-511404-17-00_SE-SV_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_BE-DE_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_BE-FR_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_BE-NL_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_CZ-CZ_For publication | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_DE-DE_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_DK-DA_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_EN_For publication | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_ES-ES_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_FR-FR_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_IT-IT_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_NL-NL_For publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_NO-NO_For Publication | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511404-17-00_SE-SV_For publication | 2.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-28 | Sweden | Acceptable 2024-09-16
|
2024-09-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-25 | Acceptable 2025-01-23
|
2025-01-23 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-19 | Acceptable | 2025-03-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-01 | Acceptable | 2025-04-15 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-20 | Sweden | Acceptable | 2025-08-20 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-21 | Sweden | Acceptable | 2025-11-21 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-25 | Acceptable | 2026-01-07 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-02 | Sweden | Acceptable | 2026-02-02 |