COLUMBUS-AD: Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

• Sponsor: Pierre Fabre Medicament (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05270044
• Collaborator: European Organisation for Research and Treatment of Cancer - EORTC (Other)
• Enrollment: 815
• Locations: 170
• Arms: 2
• Anticipated Duration (Months): 156
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: Encorafenib and Binimetinib; Drug: Placebo to match Encorafenib ; Placebo to match Binimetinib	Phase 3

Detailed Description

This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial.

Participants with completely resected cutaneous melanoma and documented BRAF V600E/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between:

• stage IIB (i.e., pT3b or pT4a)

• stage IIC (i.e., pT4b).

The long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 815 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group
• Actual Study Start Date: May 2, 2022
• Anticipated Primary Completion Date: Mar 31, 2027
• Anticipated Study Completion Date: May 2, 2035

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Encorafenib and Binimetinib	Drug: Encorafenib and Binimetinib; Encorafenib 450 mg (6 × 75 mg capsules) once daily (QD) and binimetinib 45 mg (3 x 15 mg tablets) twice daily (BID) orally for a maximum of 12 months.; Other Names: Encorafenib: Braftovi / Binimetinib: Mektovi
Placebo Comparator: Arm B Placebo to match Encorafenib Placebo to match Binimetinib	Drug: Placebo to match Encorafenib ; Placebo to match Binimetinib; Encorafenib (6 × 75 mg placebo capsules) QD and binimetinib (3 × 15 mg placebo tablets) BID placebos orally for a maximum of 12 months.

Outcome Measures

Primary Outcome Measures

1. Recurrence-free survival (RFS) [Approximately 4.4 years from the accrual of the first patient.]

   RFS is defined as the time between the date of randomization and the date of 1) first recurrence (local, regional, or a distant metastasis), 2) new melanoma that is known to be either ulcerated, thick (Breslow thickness>1 mm) or requiring a treatment other than surgery or 3) death (whatever the cause), whichever occurs first.

Secondary Outcome Measures

1. Distant metastasis-free survival (DMFS) [Approximately 6.0 years from first patient in]

   DMFS is defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first.

2. Overall survival (OS) [Approximately 10 years from first Patient In.]

   OS is defined as time from randomization to the date of death whatever the cause.

3. Safety - Incidence, nature, severity and seriousness of treatment emergent adverse events (TEAEs) [From the signing of the ICF up to 30 days after end of treatment- approximately 14.5 months]

   Incidence nature and severity of adverse events and SAEs graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

4. Safety -Incidence, nature and severity of cutaneous malignancies by dermatological examination [From the signing of ICF to study completion- approximately 10 years from last patient in]

   This is to monitor for the possible development of keratoacanthoma and/or squamous cell carcinoma and new primary melanoma, as these have been reported to occur with selective BRAF inhibitor treatment. Incidence, nature and severity of new cutaneous malignancies (kerantoacanthoma, squamous cell carcinoma and new primary melanoma) will be recorded and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

5. Safety -Incidence of Serious adverse events (SAEs) [From the signing of the ICF to study completion- approximately 10 years from last patient in]

   Incidence nature and severity of serious adverse events will be recorded and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

6. Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in physical examination [From the signing of the ICF up to 30 days after end of treatment- approximately up to 14.5 months]

   Standard physical examinations on cardiovascular, respiratory, gastrointestinal, dermatological, ophthalmological and neurological systems will be performed and will be evaluated based on normal/abnormal and clinical significance observations. Number of participants with TEAEs related to abnormal or clinical significance observations to the physical examinations after the start of study drug will be reported.

7. Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in vital signs [From the signing of the ICF up to 30 days after end of treatment- approximately up to 14.5 months]

   Clinically notable elevated values: Systolic blood pressure (BP): ≥ 160 mmHg and an increase ≥ 20 mmHg from baseline; Diastolic BP: ≥ 100 mmHg and an increase ≥ 15 mmHg from baseline; Heart rate: ≥ 100 beats/min (bpm) with increase from baseline of ≥ 15 bpm; Body temperature [°C] ≥ 38°C). Clinically notable low values: Systolic BP: <120 mmHg with decrease from baseline of ≥ 20 mmHg; Diastolic BP: < 80 mmHg with decrease from baseline of ≥ 15 mmHg; Heart rate: <50 bpm with decrease from baseline of ≥ 15 bpm; Body temperature [°C]: ≤ 35 °C

8. Safety and tolerability : Incidence of TEAEs related to notable changes in clinical safety laboratory parameters from baseline. [From the signing of the ICF up to 30 days after end of treatment- approximately up to 14.5 months]

   incidence of treatment-emergent adverse events (TEAEs) related to notable changes in clinical safety laboratory parameters from baseline. Number of participants with clinically notable shift from baseline in laboratory parameter values based on national cancer institute common terminology criteria (NCI-CTCAE) grade, Version 5.0 will be graded from Grades 1 to 5. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Clinically notable shift is defined as a worsening from baseline by at least 2 grades, or to grade 3 or above.

9. Safety and tolerability -Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of 12-lead electrocardiograms (ECGs) [From the signing of the ICF up to 30 days after end of treatment-approximately up to 14.5 months]

   12-lead ECGs will be obtained using an internationally recognized 12-lead cardiograph. Clinically notable ECG values: QT [millisecond (ms)] and QT interval (ms) corrected for heart rate using Fridericia's formula (QTcF) intervals (ms): increase from baseline > 60 ms, new > 450 ms, new > 480 ms, new > 500 ms.

10. Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of echocardiogram or multigated acquisition (ECHO/MUGA) scans. [From the signing of the ICF up to 30 days after end of treatment-approximately up to 14.5 months]

    ECHO/MUGA scan assess Left Ventricular Ejection Fraction (LVEF). Changes from baseline of LVEF measurements over time will be reported

11. Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in ophtalmic examination [From the signing of the ICF up to 30 days after end of treatment-approximately up to 14.5 months]

    Changes from baseline and worse value on ophthalmic examination over time will be reported. a full ophthalmic examination by an ophthalmologist will be performed (at baseline an end of treatment) including best corrected visual acuity (BCVA), slit lamp examination, intraocular pressure (IOP), dilatedfundoscopy and optical coherence tomography (OCT). Retinal examination is required to identify findings associated with retinal pigment epithelial detachments (RPED), serous detachment of the retina and RVO (OCT and angiography). the investigator will also monthly monitor visual assesment (general inspection of the eyes, examination of motility and alignment, visual disturbance including diminished central vision, blurred vision or loss of vision).

12. Safety and tolerability-Treatment emergent adverse events (TEAEs) leading to dose interruption, reduction and discontinuation. [On treatment period - 12 months from randomization.]

    Incidence of dose interruptions, dose modifications and discontinuation due to AEs and incidence of AEs requiring additional therapy

13. Performance status using the Eastern Co-operative Oncology Group (ECOG) performance status scale. [From the signing of the ICF up to 30 days after end of treatment-approximately up to 14.5 months]

    Changes from baseline and worse value on Eastern Cooperative Oncology Group (ECOG) Scale with a range from 0 to 5 with lower score mean a lower functional impairment, 5 corresponding to death .

14. Patient-reported health-related (HRQoL)-European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) . [From the signing of the ICF up to 30 months.]

    To determine if there is any change from baseline during the treatment and every 6 months thereafter up to 30 months in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire scores. EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The descriptive system has five dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each is rated according to a five-point verbal rating scale (VRS): 1. no problems, 2. slight problems, 3. moderate problems, 4. severe problems and 5. extreme problems) and translated into a five-digit number that describes the participant's health state

15. Patient-reported health-related (HRQoL)_European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients (EORTC QLQ-C30) [From the signing of the ICF up to 30 months.]

    To determine if there is any change from baseline during the treatment and every 6 months thereafter up to 30 months in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients (EORTC QLQ-C30) questionnaire scores EORTC QLQ-C30 consists of fifteen multi-item scales: five functional scales (physical, role, cognitive, emotional and social); nine symptom/items scales (fatigue, pain, nausea, vomiting, dyspnea, insomnia, apetite loss, constipation, diarrhae and financial difficulties) and a global health and Quality of Life (QoL) scale. Each scale in the questionnaire will be scored (0 to 100). High scores represents a high health/quality of life

16. Pharmacokinetic (PK) parameter of encorafenib and its metabolite (LHY746)_Cmin [From randomization up to 11 months]

    Minimum serum concentration (Cmin) will be calculated and reported.

17. Pharmacokinetic (PK) parameter of encorafenib and its metabolite (LHY746)-Cmax [From randomization up to 11 months]

    Maximum serum concentration (Cmax) will be calculated and reported.

18. Pharmacokinetic (PK) parameter of encorafenib and its metabolite (LHY746)_AUC [From randomization up to 11 months]

    Area under the curve (AUC) will be calculated and reported.

19. Pharmacokinetic (PK) parameter of binimetinib and its metabolite (AR00426032)-Cmin [From randomization up to 11 months]

    Minimum serum concentration (Cmin) will be calculated and reported

20. Pharmacokinetic (PK) parameter of binimetinib and its metabolite (AR00426032)-Cmax [From randomization up to 11 months]

    Maximum serum concentration (Cmax) will be calculated and reported.

21. Pharmacokinetic (PK) parameter of binimetinib and its metabolite (AR00426032)-AUC [From randomization up to 11 months]

    Area under the curve (AUC) will be calculated and reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Pre-Screening

• Male or female ≥ 18 years of age;

• Surgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;

• Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.

• Sentinel node (SN) staged node negative (pN0);

• Available tumour sample for central determination of the BRAF V600E/K mutation.

Screening

• Melanoma confirmed centrally to be BRAF V600E/K mutation-positive;

• Participant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);

• No more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;

• Recovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);

• ECOG performance status of 0 or 1;

• Adequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin

≥ 9.0 g/dL;

• Adequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;

• Adequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;

• Adequate hepatic function as defined as Serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN;

• Adequate cardiac function as defined as LVEF ≥ 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value ≤ 480 msec and no history of QT syndrome;

• Adequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;

• Negative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;

• Female patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for ≥30 days after last administration.

Exclusion Criteria:

Pre-screening

• Unknown ulceration status;

• Uveal and mucosal melanoma;

• Clinically apparent metastases (N+/M1);

• Microsatellites, satellites and/or in-transit metastases,

• Local (scar) recurrences.

Screening

• Breast feeding women;

• Pregnant women;

• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;

• History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to randomization;

• History of previous or concurrent malignancy within preceding 3 years or any condition with a life expectancy of less than 5 years;

• Participants with a prior cancer associated with RAS mutation;

• Prior systemic anticancer therapy for melanoma or radiotherapy for melanoma;

• Hypersensitivity to the study drugs or to any of the excipients;

• Participants with severe lactose intolerance (e.g., Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption);

• Impaired cardiovascular function or clinically significant cardiovascular diseases;

• Neuromuscular disorders that are associated with CK > ULN (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy);

• Non-infectious pneumonitis and Interstitial Lung Disease;

• Positive SARs-CoV-2 or variants of SARs-CoV2 RT-PCR test at screening or suspected to be infected with SARs-CoV2 or variants of SARsCoV2 with confirmation pending;

• Active bacterial, fungal, or viral infection, including, but not limited to HBV, HCV, and known HIV or AIDS-related illness, or an infection requiring systemic therapeutic treatment within 2 weeks prior to randomization.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Oncologico Korben	Caba	Buenos Aires	Argentina	C1426
2	Centro de Investigaciones Medicas Mar del Plata	Mar Del Plata	Buenos Aires	Argentina	B7600FYK
3	Fundacion CIDEA	Ciudad Autonoma Bs As	Ciudad Autonoma Buenos Aires	Argentina	C1121ABE
4	Sanatorio Britanico S.A.	Rosario	Santa Fe	Argentina	2000
5	Instituto de Oncologia de Rosario	Rosario	Santa Fe	Argentina	S2000KZE
6	Hospital Aleman	Ciudad Autonoma Buenos Aires		Argentina	C1118AAT
7	Instituto Medico Especializado Alexander Fleming	Ciudad Autonoma Buenos Aires		Argentina	C1426ANZ
8	Clinica Adventista Belgrano	Ciudad Autonoma Buenos Aires		Argentina	C1430EGF
9	Port Macquarie Base Hospital	Port Macquarie	New South Wales	Australia	2444
10	Westmead Hospital	Sydney	New South Wales	Australia	2145
11	Melanoma Institute Australia	Wollstonecraft	New South Wales	Australia	2065
12	Cairns Hospital	Cairns	Queensland	Australia	4870
13	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
14	Adelaide Oncology & Haematology	North Adelaide	South Australia	Australia	5006
15	Box Hill Hospital	Box Hill	Victoria	Australia	3128
16	Frankston Hospital	Frankston	Victoria	Australia	3199
17	Austin Health	Heidelberg	Victoria	Australia	3084
18	The Alfred Hospital	Prahran	Victoria	Australia	3181
19	Hollywood Private Hospital	Nedlands	Western Australia	Australia	6009
20	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
21	Landeskrankenhaus - Universitaetsklinikum Graz	Graz		Austria	8036
22	Krankenhaus der Elisabethinen Linz	Linz		Austria	4020
23	Universitätsklinikum St.Pölten-Lilienfeld	St. Pölten		Austria	3100
24	AKH - Medizinische Universität Wien	Vienna		Austria	1090
25	Institut Jules Bordet	Anderlecht		Belgium	1070
26	ZNA Middelheim	Antwerpen		Belgium	2020
27	Cliniques Universitaires Saint-Luc	Brussels		Belgium	1200
28	Universitair Ziekenhuis Brussel	Brussel		Belgium	1090
29	UZ Gent	Gent		Belgium	9000
30	CHU de Liège	Liège		Belgium	4000
31	ZNA	Merksem		Belgium	2170
32	Vitaz	Sint-Niklaas		Belgium	9100
33	CHU UCL Namur	Yvoir		Belgium	5530
34	AMO - Assistência Multidisciplinar em Oncologia	Salvador	Bahia	Brazil	41950-640
35	Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer	Curitiba	Paraná	Brazil	81520-060
36	Instituto de Cancer de Londrina	Londrina	Paraná	Brazil	86015-520
37	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil	90035-903
38	HGB - Hospital Giovanni Battista - Mãe de Deus Center	Porto Alegre	Rio Grande Do Sul	Brazil	90110-270
39	Instituto de Oncologia Saint Gallen	Santa Cruz Do Sul	Rio Grande Do Sul	Brazil	96810-110
40	CEPON - Centro de Pesquisas Oncológicas de Santa Catarina	Florianópolis	Santa Catarina	Brazil	88034-000
41	Fundação Doutor Amaral Carvalho	Jaú	Sao Paulo	Brazil	17210-120
42	CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia	Santo André	Sao Paulo	Brazil	09060-870
43	A. C. Camargo Cancer Center	São Paulo	Sao Paulo	Brazil	01509-900
44	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
45	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario	Canada	K7L 5P9
46	London Health Sciences Centre (LHSC) - Victoria Hospital	London	Ontario	Canada	N6A 5W9
47	Toronto Sunnybrook Hospital	Toronto	Ontario	Canada	M4N 3M5
48	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9
49	SMBD Jewish General Hospital d/b/a Jewish General Hospital	Montréal	Quebec	Canada	H3T 1E2
50	Fakultni nemocnice Hradec Kralove	Hradec Králové		Czechia	500 05
51	Fakultni nemocnice Olomouc	Olomouc		Czechia	79900
52	Fakultni nemocnice Ostrava	Ostrava - Poruba		Czechia	708 52
53	Fakultni nemocnice Kralovske Vinohrady	Praha 10		Czechia	100 34
54	Vseobecna fakultni nemocnice v Praze	Praha 2		Czechia	128 08
55	CHU Nice - Hopital de l Archet 2	Nice cedex 3	Alpes Maritimes	France	06202
56	Hôpital de la Timone	Marseille cedex 5	Bouches-du-Rhône	France	13385
57	CHU de Dijon - Hôpital du Bocage	Dijon	Cote dÝOr	France	21079
58	CHU de Bordeaux - Hôpital Saint André	Bordeaux	Gironde	France	33075
59	Institut Claudius Regaud - Oncopole	Toulouse	Haute Garonne	France	31059
60	Hôpital Ambroise Paré	Boulogne-Billancourt	Hauts De Seine	France	92100
61	CRLCC Eugene Marquis	Rennes cedex	Ille Et Vilaine	France	35042
62	CHU Tours - Hôpital Trousseau	Chambray-lès-Tours	Indre Et Loire	France	37170
63	CHU de Grenoble - Hôpital André Michallon	La Tronche	Isere	France	38700
64	CHU Nantes - Hôtel Dieu	Nantes Cedex 1	Loire Atlantique	France	44093
65	CHU Saint Etienne - Hôpital Nord	Saint Etienne Cedex 2	Loire	France	42055
66	Hopital Claude Huriez - CHU Lille	Lille cedex	Nord	France	59037
67	Hôpital Saint-Louis	Paris Cedex 10	Paris	France	75010
68	CAC Clermont-Ferrand Centre Jean Perrin	Clermont-Ferrand	Puy De Dome	France	63000
69	Service de Dermatologie	Pierre Bénite cedex	Rhone	France	69495
70	Institut Gustave Roussy	Villejuif cedex	Val De Marne	France	94805
71	CHU Poitiers - Hôpital la Milétrie	Poitiers	Vienne	France	86021
72	Universitaetsklinikum Heidelberg	Heidelberg	Baden Wuerttemberg	Germany	69120
73	Universitaetsklinikum Wuerzburg	Wuerzburg	Bayern	Germany	97080
74	Elbekliniken Buxtehude GmbH	Buxtehude	Niedersachsen	Germany	21614
75	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden	Sachsen	Germany	01307
76	Universitaetsklinikum Schleswig-Holstein	Kiel	Schleswig Holstein	Germany	24105
77	Universitaetsklinikum Hamburg-Eppendorf	Hamburg		Germany	20246
78	General Hospital of Athens Laiko	Athens		Greece	11527
79	Metropolitan Hospital	Néo Fáliro		Greece	18547
80	Bioclinic Thessaloniki	Thessaloníki		Greece	54622
81	Anticancer Hospital of Thessaloniki " Theagenio"	Thessaloníki		Greece	54639
82	Interbalkan Hospital of Thessaloniki	Thessaloníki		Greece	57001
83	Semmelweis Egyetem	Budapest		Hungary	1085
84	Orszagos Onkologiai Intezet	Budapest		Hungary	1122
85	Debreceni Egyetem	Debrecen		Hungary	4032
86	Petz Aladar Egyetemi Oktato Korhaz	Győr		Hungary	9023
87	Pecsi Tudomanyegyetem	Pécs		Hungary	7632
88	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged		Hungary	6720
89	HaEmek Medical Center	Afula		Israel	18101
90	Hadassah University Hospital - Ein Kerem	Jerusalem		Israel	9112001
91	Rabin Medical Center-Beilinson Campus	Petach Tikva		Israel	4941492
92	Chaim Sheba Medical Center	Ramat Gan		Israel	5262001
93	IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST	Meldola	Forli - Cesena	Italy	47014
94	Ospedale San Vincenzo	Taormina	Messina	Italy	98039
95	Istituto Nazionale Tumori Fondazione G. Pascale	Naples	Napoli	Italy	80131
96	IRCCS Centro di Riferimento Oncologico	Aviano	Pordenone	Italy	33081
97	Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari	Bari		Italy	70124
98	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)	Bergamo		Italy	24127
99	Azienda Sanitaria Ospedaliera S.Croce e Carle	Cuneo		Italy	12100
100	IRCCS Ospedale Policlinico San Martino	Genova		Italy	16132
101	Ospedale San Raffaele	Milano		Italy	20132
102	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano		Italy	20133
103	IEO Istituto Europeo di Oncologia	Milano		Italy	20141
104	IOV - Istituto Oncologico Veneto IRCCS	Padova		Italy	35128
105	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone	Palermo		Italy	90127
106	Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia	Perugia		Italy	06156
107	Azienda Ospedaliero Universitaria Pisana	Pisa		Italy	56126
108	IDI-Istituto Dermopatico dell'Immacolata IRCCS	Roma		Italy	00167
109	Policlinico Universitario di Sassari	Sassari		Italy	07100
110	A.O.U. Senese Policlinico Santa Maria alle Scotte	Siena		Italy	53100
111	Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino	Torino		Italy	10126
112	Azienda Sanitaria Universitaria Friuli Centrale	Udine		Italy	33100
113	Antoni van Leeuwenhoek	Amsterdam		Netherlands	1066 CX
114	Universitair Medisch Centrum Groningen (UMCG)	Groningen		Netherlands	9713 GZ
115	Leids Universitair Medisch Centrum	Leiden		Netherlands	2333 ZA
116	Maastricht University Medical Center	Maastricht		Netherlands	6202 AZ
117	Radboudumc	Nijmegen		Netherlands	6525 GA
118	Erasmus MC	Rotterdam		Netherlands	3015 GD
119	UMC Utrecht	Utrecht		Netherlands	3508 GA
120	Isala	Zwolle		Netherlands	8025 AB
121	Oslo University Hospital	Oslo		Norway	0424
122	Ålesund Hospital	Ålesund		Norway	6017
123	Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Gliwice		Poland	44-102
124	Przychodnia Lekarska Komed	Konin		Poland	62-500
125	Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie	Kraków		Poland	31-115
126	Wielkopolskie Centrum Onkologii	Poznań		Poland	61-866
127	Centrum Medyczne Pratia Poznan	Skórzewo		Poland	60-185
128	Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy	Warszawa		Poland	02-781
129	Dolnoslaskie Centrum Onkologii	Wrocław		Poland	53-413
130	Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE	Lisboa		Portugal	1099-023
131	Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisboa		Portugal	1649-035
132	Instituto Português de Oncologia do Porto Francisco Gentil, EPE	Porto		Portugal	4200-072
133	FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"	Moscow		Russian Federation	115478
134	BHI of Omsk region "Clinical Oncology Dispensary"	Omsk		Russian Federation	644013
135	SPb SBIH "City Clinical Oncological Dispensary"	Saint Petersburg		Russian Federation	197022
136	Clinical Center "Bezanijska kosa"	Belgrade		Serbia	11000
137	Institute of Oncology and Radiology of Serbia	Belgrade		Serbia	11000
138	Clinical Center Kragujevac	Kragujevac		Serbia	34000
139	Clinical Center Nis	Niš		Serbia	18000
140	Oncology Institute of Vojvodina	Sremska Kamenica		Serbia	21204
141	National Hospital Oncology	Bloemfontein	Free State	South Africa	9301
142	Johese Clinical Research: Midstream	Centurion	Gauteng	South Africa	1692
143	Sandton Oncology Medical Group	Johannesburg	Gauteng	South Africa	2196
144	ICO Badalona - Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
145	ICO l'Hospitalet - Hospital Duran i Reynals	L'Hospitalet De Llobregat	Barcelona	Spain	08908
146	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia	Spain	30120
147	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
148	Hospital Clinic de Barcelona	Barcelona		Spain	08036
149	Hospital Universitario Reina Sofia	Córdoba		Spain	14004
150	Hospital General Universitario Gregorio Marañon	Madrid		Spain	28007
151	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
152	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
153	Centro Integral Oncologico Clara Campal	Madrid		Spain	28050
154	Hospital Regional Universitario de Malaga	Málaga		Spain	29010
155	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
156	Hospital General Universitario de Valencia	Valencia		Spain	46014
157	Karolinska University Hospital	Stockholm		Sweden	17176
158	Norrlands Universitetssjukhus	Umeå		Sweden	901 87
159	Universitaetsspital Zuerich	Zuerich		Switzerland	8091
160	CNE"City Clin Hosp#4"of Dnipro City Council Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU	Dnipro		Ukraine	49102
161	CHI Kharkiv Regional Clinical Oncological Center	Kharkiv		Ukraine	61070
162	SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine	Kharkiv		Ukraine	61103
163	Medical Clinic Innovacia, LLC	Kiev		Ukraine	07352
164	MI Kirovograd Regional Oncological Dispensary	Kropyvnytskyi		Ukraine	25011
165	National Institute of Cancer	Kyiv		Ukraine	03022
166	Odesa Regional Oncologic Dispensary	Odesa		Ukraine	65055
167	CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU	Úzhgorod		Ukraine	88000
168	Royal Preston Hospital	Preston	Lancashire	United Kingdom	PR2 9HT
169	Mount Vernon Hospital	Northwood	Middlesex	United Kingdom	HA6 2RN
170	Northern Centre for Cancer Care	Newcastle Upon Tyne	Tyne & Wear	United Kingdom	NE7 7DN

Sponsors and Collaborators

• Pierre Fabre Medicament
• European Organisation for Research and Treatment of Cancer - EORTC

Investigators

• Study Chair: Alexander C.J. van AKKOOI, MD, PhD, European Organisation for Research and Treatment of Cancer - EORTC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pierre Fabre Medicament
• ClinicalTrials.gov Identifier: NCT05270044
• Other Study ID Numbers: W00090GE303/EORTC-2139-MG
• First Posted: Mar 8, 2022
• Last Update Posted: Jul 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pierre Fabre Medicament: Melanoma; Stage II; BRAFV600E/K; Adjuvant
• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of Jul 8, 2022