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Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.
Study Purpose
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).
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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.
- - 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.
- - 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.
- - 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.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05270044 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Pierre Fabre Medicament |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Alexander C.J. van AKKOOI, MD, PhD |
| Principal Investigator Affiliation | European Organisation for Research and Treatment of Cancer - EORTC |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry, Other |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma |
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).
Arms
Experimental: Arm A
Encorafenib and Binimetinib
Placebo Comparator: Arm B
Placebo to match Encorafenib Placebo to match Binimetinib
Interventions
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.
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Address
Centro Oncologico Korben
CABA, Buenos Aires 3435907, C1426
Status
Address
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata 3430863, Buenos Aires 3435907, B7600FYK
Status
Address
Fundacion CIDEA
Ciudad Autonoma Bs As, Ciudad Autonoma Buenos Aires, C1121ABE
Status
Address
Sanatorio Britanico S.A.
Rosario 3838583, Santa Fe Province 3836276, 2000
Status
Address
Instituto de Oncologia de Rosario
Rosario 3838583, Santa Fe Province 3836276, S2000KZE
Status
Address
Hospital Aleman
Ciudad Autonoma Buenos Aires, , C1118AAT
Status
Address
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires, , C1426ANZ
Status
Address
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, , C1430EGF
Status
Address
Westmead Hospital
Sydney 2147714, New South Wales 2155400, 2145
Status
Address
Melanoma Institute Australia
Wollstonecraft 9972972, New South Wales 2155400, 2065
Status
Address
Princess Alexandra Hospital
Woolloongabba 6943568, Queensland 2152274, 4102
Status
Address
Adelaide Oncology & Haematolog, Calvary North Adelaide Hospital
North Adelaide 8469169, South Australia 2061327, 5006
Status
Address
Box Hill Hospital
Box Hill 2174360, Victoria 2145234, 3128
Status
Address
Austin Health
Heidelberg 2163654, Victoria 2145234, 3084
Status
Address
The Alfred Hospital
Prahran 2152593, Victoria 2145234, 3181
Status
Address
Hollywood Private Hospital
Nedlands 2064874, Western Australia 2058645, 6009
Status
Address
Sir Charles Gairdner Hospital
Nedlands 2064874, Western Australia 2058645, 6009
Status
Address
Landeskrankenhaus - Universitaetsklinikum Graz
Graz 2778067, , 8036
Status
Address
Krankenhaus der Elisabethinen Linz
Linz 2772400, , 4020
Status
Address
Universitätsklinikum St.Pölten-Lilienfeld
Sankt Pölten 2766429, , 3100
Status
Address
AKH - Medizinische Universität Wien
Vienna 2761369, , 1090
Status
Address
Institut Jules Bordet
Anderlecht 2803201, , 1070
Status
Address
ZNA Middelheim
Antwerp 2803138, , 2020
Status
Address
Universitair Ziekenhuis Brussel
Brussels 2800866, , 1090
Status
Address
Cliniques Universitaires Saint-Luc
Brussels 2800866, , 1200
Status
Address
UZ Gent
Ghent 2797656, , 9000
Status
Address
ZNA
Merksem 2791301, , 2170
Status
Address
Vitaz
Sint-Niklaas 2786578, , 9100
Status
Address
CHU UCL Namur
Yvoir 2783385, , 5530
Status
Address
AMO - Assistência Multidisciplinar em Oncologia
Salvador 3450554, Estado de Bahia 3471168, 41950-640
Status
Address
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba 3464975, Paraná 3455077, 81520-060
Status
Address
Instituto de Cancer de Londrina
Londrina 3458449, Paraná 3455077, 86015-520
Status
Address
Hospital de Clínicas de Porto Alegre
Porto Alegre 3452925, Rio Grande do Sul 3451133, 90035-903
Status
Address
HGB - Hospital Giovanni Battista - Mãe de Deus Center
Porto Alegre 3452925, Rio Grande do Sul 3451133, 90110-270
Status
Address
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul 3450269, Rio Grande do Sul 3451133, 96810-110
Status
Address
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Florianópolis 3463237, Santa Catarina 3450387, 88034-000
Status
Address
Fundação Doutor Amaral Carvalho
Jaú 3460005, São Paulo 3448433, 17210-120
Status
Address
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André 3449701, São Paulo 3448433, 09060-870
Status
Address
A. C. Camargo Cancer Center
São Paulo 3448439, São Paulo 3448433, 01509-900
Status
Address
London Health Sciences Centre (LHSC) - Victoria Hospital
London 6058560, Ontario 6093943, N6A 5W9
Status
Address
Toronto Sunnybrook Hospital
Toronto 6167865, Ontario 6093943, M4N 3M5
Status
Address
Princess Margaret Cancer Centre
Toronto 6167865, Ontario 6093943, M5G 2M9
Status
Address
CIUSSS du Centre Ouest de l'lle de Montreal
Montreal 6077243, Quebec 6115047, H3T 1E2
Status
Address
Fakultni nemocnice Hradec Kralove
Hradec Králové 3074967, , 500 05
Status
Address
Fakultni nemocnice Olomouc
Olomouc 3069011, , 79900
Status
Address
Fakultni nemocnice Ostrava
Ostrava - Poruba, , 708 52
Status
Address
Fakultni nemocnice Kralovske Vinohrady
Prague 3067696, , 100 34
Status
Address
Vseobecna fakultni nemocnice v Praze
Prague 3067696, , 128 08
Status
Address
CHU Nice - Hopital de l Archet 2
Nice 2990440, Alpes Maritimes, 06202
Status
Address
Hôpital de la Timone
Marseille 2995469, Bouches-du-Rhône, 13385
Status
Address
CHU de Dijon - Hôpital du Bocage
Dijon 3021372, Cote dÝOr, 21079
Status
Address
CHU de Bordeaux - Hôpital Saint André
Bordeaux 3031582, Gironde, 33075
Status
Address
Institut Claudius Regaud - Oncopole
Toulouse 2972315, Haute Garonne, 31059
Status
Address
Hôpital Ambroise Paré
Boulogne-Billancourt 3031137, Hauts De Seine, 92100
Status
Address
CRLCC Eugene Marquis
Rennes 2983990, Ille Et Vilaine, 35042
Status
Address
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours 3027343, Indre Et Loire, 37170
Status
Address
CHU de Grenoble - Hôpital André Michallon
La Tronche 3006131, Isere, 38700
Status
Address
CHU Nantes - Hôtel Dieu
Nantes 2990969, Loire Atlantique, 44093
Status
Address
Hopital Claude Huriez - CHU Lille
Lille 2998324, Nord, 59037
Status
Address
Hôpital Saint-Louis
Paris 2988507, Paris, 75010
Status
Address
CHU Saint Etienne - Hôpital Nord
Saint-Étienne-de-Montluc 2980259, Pays de la Loire Region 2988289, 42055
Status
Address
CAC Clermont-Ferrand Centre Jean Perrin
Clermont-Ferrand 3024635, Puy De Dome, 63000
Status
Address
Centre Hospitalier de Pau - Hôpital François Mitterrand
Pau 2988358, Pyrenees Atlantiques, 64046
Status
Address
Centre Hospitalier Lyon Sud
Pierre-Bénite 2987314, Rhone, 69495
Status
Address
CHU de Rouen - Hôpital Charles Nicolle
Rouen 2982652, Seine Maritime, 76031
Status
Address
Institut Gustave Roussy
Villejuif 2968705, Val De Marne, 94805
Status
Address
CHU Poitiers - Hôpital la Milétrie
Poitiers 2986495, Vienne, 86021
Status
Address
Universitaetsklinikum Heidelberg
Heidelberg 2907911, Baden-Wurttemberg 2953481, 69120
Status
Address
Universitaetsklinikum Wuerzburg
Würzburg 2805615, Bavaria 2951839, 97080
Status
Address
Elbekliniken Buxtehude GmbH
Buxtehude 2940451, Lower Saxony 2862926, 21614
Status
Address
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden 2935022, Saxony 2842566, 01307
Status
Address
Universitaetsklinikum Schleswig-Holstein
Kiel 2891122, Schleswig-Holstein 2838632, 24105
Status
Address
Universitaetsklinikum Hamburg-Eppendorf
Hamburg 2911298, , 20246
Status
Address
General Hospital of Athens Laiko
Athens 264371, , 11527
Status
Address
Metropolitan Hospital
Neo Faliro 256495, , 18547
Status
Address
Bioclinic Thessaloniki
Thessaloniki 734077, , 54622
Status
Address
Anticancer Hospital of Thessaloniki " Theagenio"
Thessaloniki 734077, , 54639
Status
Address
Interbalkan Hospital of Thessaloniki
Thessaloniki 734077, , 57001
Status
Address
Semmelweis Egyetem
Budapest 3054643, , 1085
Status
Address
Orszagos Onkologiai Intezet
Budapest 3054643, , 1122
Status
Address
Debreceni Egyetem
Debrecen 721472, , 4032
Status
Address
Petz Aladar Egyetemi Oktato Korhaz
Győr 3052009, , 9023
Status
Address
Pecsi Tudomanyegyetem
Pécs 3046526, , 7632
Status
Address
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged 715429, , 6720
Status
Address
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST
Meldola 3173635, Forli - Cesena, 47014
Status
Address
Ospedale San Vincenzo
Taormina 2522975, Messina, 98039
Status
Address
Istituto Nazionale Tumori Fondazione G. Pascale
Naples 3172394, Napoli, 80131
Status
Address
IRCCS Centro di Riferimento Oncologico
Aviano 3182635, Pordenone, 33081
Status
Address
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari 3182351, , 70124
Status
Address
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo 3182164, , 24127
Status
Address
Azienda Sanitaria Ospedaliera S.Croce e Carle
Cuneo 3177700, , 12100
Status
Address
IRCCS Ospedale Policlinico San Martino
Genova 8969657, , 16132
Status
Address
Ospedale San Raffaele
Milan 6951411, , 20132
Status
Address
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan 6951411, , 20133
Status
Address
IEO Istituto Europeo di Oncologia
Milan 6951411, , 20141
Status
Address
IOV - Istituto Oncologico Veneto IRCCS
Padua 3171728, , 35128
Status
Address
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo 2523920, , 90127
Status
Address
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia 3171180, , 06156
Status
Address
Azienda Ospedaliero Universitaria Pisana
Pisa 3170647, , 56126
Status
Address
Istituto Nazionale Tumori Regina Elena IRCCS
Roma 8957247, , 00144
Status
Address
IDI-Istituto Dermopatico dell'Immacolata IRCCS
Roma 8957247, , 00167
Status
Address
Policlinico Universitario di Sassari
Sassari 3167096, , 07100
Status
Address
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena 3166548, , 53100
Status
Address
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino 8980539, , 10126
Status
Address
Azienda Sanitaria Universitaria Friuli Centrale
Udine 3165072, , 33100
Status
Address
Antoni van Leeuwenhoek
Amsterdam 2759794, , 1066 CX
Status
Address
Universitair Medisch Centrum Groningen (UMCG)
Groningen 2755251, , 9713 GZ
Status
Address
Leids Universitair Medisch Centrum
Leiden 2751773, , 2333 ZA
Status
Address
Maastricht University Medical Center
Maastricht 2751283, , 6202 AZ
Status
Address
Radboudumc
Nijmegen 2750053, , 6525 GA
Status
Address
Erasmus MC
Rotterdam 2747891, , 3015 GD
Status
Address
UMC Utrecht
Utrecht 2745912, , 3508 GA
Status
Address
Isala
Zwolle 2743477, , 8025 AB
Status
Address
Ålesund Hospital
Ålesund 3163392, , 6017
Status
Address
Oslo University Hospital
Oslo 3143244, , 0424
Status
Address
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Gliwice 3099230, , 44-102
Status
Address
Przychodnia Lekarska Komed
Konin 3095321, , 62-500
Status
Address
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
Krakow 3094802, , 31-115
Status
Address
Wielkopolskie Centrum Onkologii
Poznan 3088171, , 61-866
Status
Address
Centrum Medyczne Pratia Poznan
Skórzewo 3085750, , 60-185
Status
Address
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw 756135, , 02-781
Status
Address
Dolnoslaskie Centrum Onkologii
Wroclaw 3081368, , 53-413
Status
Address
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon 2267057, , 1099-023
Status
Address
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon 2267057, , 1649-035
Status
Address
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto 2735943, , 4200-072
Status
Address
S.C Medisprof S.R.L
Cluj-Napoca 681290, , 400641
Status
Address
S.C Centrul de Oncologie Sf. Nectarie S.R.L
Craiova 680332, , 200542
Status
Address
Institutul Regional de Oncologie Iasi
Iași 675810, , 700483
Status
Address
Clinical Center "Bezanijska kosa"
Belgrade 792680, , 11000
Status
Address
Institute of Oncology and Radiology of Serbia
Belgrade 792680, , 11000
Status
Address
Military Medical Academy
Belgrade 792680, , 11000
Status
Address
Oncology Institute of Vojvodina
Kamenitz 3190104, , 21204
Status
Address
Clinical Center Kragujevac
Kragujevac 789128, , 34000
Status
Address
Clinical Center Nis
Niš 787657, , 18000
Status
Address
National Hospital Oncology
Bloemfontein 1018725, Free State 967573, 9301
Status
Address
Johese Clinical Research: Midstream
Centurion 1105777, Gauteng 1085594, 1692
Status
Address
Sandton Oncology Medical Group
Johannesburg 993800, Gauteng 1085594, 2196
Status
Address
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona 3129028, Barcelona, 08916
Status
Address
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat 3120619, Barcelona, 08908
Status
Address
Hospital Universitario Virgen de la Arrixaca
El Palmar 2518294, Murcia 2513413, 30120
Status
Address
Hospital Universitari Vall d'Hebron
Barcelona 3128760, , 08035
Status
Address
Hospital Clinic de Barcelona
Barcelona 3128760, , 08036
Status
Address
Hospital Universitario Reina Sofia
Córdoba 2519240, , 14004
Status
Address
Hospital General Universitario Gregorio Marañon
Madrid 3117735, , 28007
Status
Address
Hospital Universitario Ramon y Cajal
Madrid 3117735, , 28034
Status
Address
Hospital Universitario 12 de Octubre
Madrid 3117735, , 28041
Status
Address
Centro Integral Oncologico Clara Campal
Madrid 3117735, , 28050
Status
Address
Hospital Regional Universitario de Malaga
Málaga 2514256, , 29010
Status
Address
Hospital Clinico Universitario de Valencia
Valencia 2509954, , 46010
Status
Address
Hospital General Universitario de Valencia
Valencia 2509954, , 46014
Status
Address
Karolinska University Hospital
Stockholm 2673730, , 17176
Status
Address
Norrlands Universitetssjukhus
Umeå 602150, , 901 87
Status
Address
Universitaetsspital Zuerich
Zurich 2657896, , 8091
Status
Address
Royal Preston Hospital
Preston 2639912, Lancashire, PR2 9HT
Status
Address
Northern Centre for Cancer Care
Newcastle upon Tyne 2641673, Tyne & Wear, NE7 7DN
