Clinical trial NCT01667419: A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients With Surgically Resected, Cutaneous BRAF-Mutant Melanoma at High Risk for Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than \[\>\] 1 millimeter \[mm\] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed melanoma of cutaneous origin
* Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected
* BRAF V600 mutation status of the current primary tumor or involved lymph node determined to be positive using the cobas BRAF V600 mutation test
* Surgically rendered free of disease within 90 days of randomization
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 5 years
* Fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b
* History of limb perfusion therapy
* History of radiotherapy for the treatment of melanoma
* Invasive malignancy other than melanoma at the time of enrollment or within 5 years prior to first dose of study treatment
* Family history of inherited colon cancer syndromes
* Known personal history of \>3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) \>2 centimeters (cm) in size
* History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions
* History of or current clinical, radiographic, or pathologic evidence of recurrent lymph node involvement after resection of a primary melanoma with lymph node involvement at any time in the past
* History of local and/or regional and/or distant melanoma recurrence
* History or current radiographic or pathologic evidence of distant metastases
* History of clinically significant cardiac or pulmonary dysfunction
* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study treatment
* Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus

Primary outcomes:
measure: Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)
timeFrame: From randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
Secondary outcomes:
measure: Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT
timeFrame: From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
measure: Overall Survival (OS)
timeFrame: From randomization until the date of death from any cause (up until 13-July-2018, approximately 6 years)
measure: Percentage of Participants With Adverse Events
timeFrame: From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years)
measure: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score
timeFrame: Day 1, Day 8, Day 15, Day 22 of Cycle 1;Day 1, Day 15 of Cycle 2;Day 1 Cycles 3-13;end of treatment(up to 13 months);every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to 17-Apr-17 data cut-off,approximately 4.5 years)
measure: Plasma Concentration of Vemurafenib
timeFrame: Pre-morning dose (0 hour [hr]) and 1 to 4 hrs post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose (0 hr) on Days 1 and 15 of Cycle 2; pre-morning dose (0 hr) on Day 1 of Cycles 3-13; at end of treatment (up to 13 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: California City
country: United States
facility: UCLA Department of Medicine; Division of Hematology / Oncology
state: California
city: Hayward
country: United States
facility: Kaiser Permanente - Hayward
state: California
city: Irvine
country: United States
facility: UCLA Hematology Oncology - Irvine
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute - W LA Office
state: California
city: Los Angeles
country: United States
facility: Cancer Center Of Santa Barbara; Network Clinical Research Specialist
state: California
city: Los Angeles
country: United States
facility: TRIO-US Network Administration; Network Clinical Research Specialist
state: California
city: Oakland
country: United States
facility: Kaiser Foundation Hospital - Oakland (W. MacArthur)
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Pasadena
country: United States
facility: UCLA Healthcare/Pasadena Oncology
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: San Jose
country: United States
facility: K. Permanente - San Jose
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente - South San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine; Stanford Hospital Pharmacy
state: California
city: Valencia
country: United States
facility: UCLA Cancer Center Hema/Oncol
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek
state: California
city: Westlake Village
country: United States
facility: UCLA Hematology Oncology - Westlake
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Cancer Center
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - Broadway
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Sarasota
country: United States
facility: GulfCoast Oncology
state: Florida
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Goshen
country: United States
facility: Indiana University Health; Goshen Center for Cancer Care
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Department of Medicine; Division of Infectious Diseases
state: Indiana
city: Louisville
country: United States
facility: U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology
state: Kentucky
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Kansas City
country: United States
facility: University of Kansas Medical Center; Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University; Dept of Medicine/Div of Medical Oncology
state: Missouri
city: Randolph
country: United States
facility: Atlantic Health Systems; Pediatrics
state: New Jersey
city: New York
country: United States
facility: New York University Medical Center PRIME; NYU Clinical Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center; Oncology
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center/cannon Park Place; Attn: Tamara Saunders
state: South Carolina
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC - Nashville (20th Ave)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Morgantown
country: United States
facility: Mary Babb Randolph Cancer Center
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Fundación CIDEA
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Derqui-Pilar
country: Argentina
facility: Hospital Universitario Austral
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Base Hospital
state: Queensland
city: Townsville
country: Australia
facility: The Townsville Hospital; Townsville Cancer Centre
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital; Hepatology
state: South Australia
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Launceston
country: Australia
facility: Launceston General Hospital; Gastroenterology Research
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Oncology Centre; Frankston Private
state: Victoria
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Wien
country: Austria
facility: Krankenanstalt Rudolfstiftung Wien
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Kortrijk
country: Belgium
facility: AZ Groeninge, Apotheek
city: Belo Horizonte
country: Brazil
facility: Trymed Clinical Research
state: MG
city: Ijuí
country: Brazil
facility: Hospital de Caridade de Ijuí
state: RO
city: Passo Fundo
country: Brazil
facility: CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Porto Alegre
country: Brazil
facility: Clinica de Oncologia de Porto Alegre - CliniOnco
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital Sírio-Libanês
state: SP
city: Vancouver
country: Canada
facility: BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency
state: British Columbia
city: Winnipeg
country: Canada
facility: Saint Boniface General Hospital; Section of Nephrology BG 007
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital; Department of Oncology
state: New Brunswick
city: London
country: Canada
facility: LHSC - Victoria Hospital; Department of Pediatrics
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Center; General Campus
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital; Department of Med Oncology
state: Ontario
city: Montreal
country: Canada
facility: CHUM Hôpital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: Mcgill University - Royal Victoria Hospital; Oncology
state: Quebec
city: Ste-Foy
country: Canada
facility: CHUQ - Hôtel-Dieu de Québec
state: Quebec
city: Pula
country: Croatia
facility: General Hospital Pula
city: Varazdin
country: Croatia
facility: General Hospital Varazdin
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Sestre Milosrdnice
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Prague
country: Czechia
facility: Nemocnice Na Bulovce
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital; Clinic of Internal Medicine
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital; Clinic of Hematology and Oncology
city: Besançon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Groupe Hospitalier Saint André - Hôpital Saint André
city: Boulogne Billancourt
country: France
facility: Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory
city: Lille
country: France
facility: Hopital Claude Huriez - CHU Lille
city: Marseille
country: France
facility: Hopital de la Timone
city: Nantes
country: France
facility: CHU NANTES - Hôtel Dieu; Pharmacy
city: Nice
country: France
facility: CHU Nice - Hopital de l'Archet 2
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: CHU de Rouen Hopital; Service de Neurologie
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Larrey
city: Bochum
country: Germany
facility: St. Josef-Hospital Universitaetsklinikum
city: Buxtehude
country: Germany
facility: Elbekliniken Buxtehude GmbH
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin
city: Koeln
country: Germany
facility: Universitätsklinikum Koeln
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitätsklinikum
city: Muenster
country: Germany
facility: Fachklinik Hornheide
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Würzburg
country: Germany
facility: Universitätsklinikum Wurzburg
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Dublin
country: Ireland
facility: The Mater Misericordiae Hospital
city: Galway
country: Ireland
facility: University College Hospital
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
state: Campania
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
state: Lazio
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena IRCCS
state: Lazio
city: Roma
country: Italy
facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS
state: Lazio
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro di Genova
state: Liguria
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
state: Lombardia
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas; Farmacia
state: Lombardia
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
state: Puglia
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte
state: Toscana
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS
state: Veneto
city: Cuernavaca
country: Mexico
facility: Centro Oncologico Belenus
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Investigación Clínica
city: Morelia
country: Mexico
facility: Sanatorio la Luz
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum; Cardiology
city: Christchurch
country: New Zealand
facility: Christchurch Hospital NZ
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Stavanger
country: Norway
facility: Stavanger Universitetssykehus, Helse Stavanger HF
city: Olsztyn
country: Poland
facility: SPZOZ MSW zWarmińsko-MazurskimCen.Onko.wOlsztynie
city: Poznan
country: Poland
facility: Przychodnia Med-Polonia Sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii
city: Coimbra
country: Portugal
facility: IPO de Coimbra; Servico de Oncologia Medica
city: Evora
country: Portugal
facility: Hospital do Espirito Santo; Servico de Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Oncologia Medica
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Krasnodar
country: Russian Federation
facility: Krasnodar City Oncology Center
city: Moscow
country: Russian Federation
facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
city: St. Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute named after N.N. Petrov
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Sremska Kamenica
country: Serbia
facility: Institute for oncology of Vojvodina
city: Cape Town
country: South Africa
facility: GVI Rondebosch Oncology Centre
city: Groenkloof
country: South Africa
facility: Mary Potter Oncology Centre
city: Observatory
country: South Africa
facility: Groote Schuur Hospital Radiation Oncology Department; Department of Radiation Oncology
city: Pretoria
country: South Africa
facility: University of Pretoria Oncology Department
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: LA Coruña
city: Marbella
country: Spain
facility: Hospital Costa del Sol; Servicio de Oncologia
state: Malaga
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu; i Sant Pau
city: Barcelona
country: Spain
facility: Institut Catala d Oncologia Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
city: Växjö
country: Sweden
facility: Centrallasarettet Växjö
city: Lausanne
country: Switzerland
facility: CHUV; Departement d'Oncologie
city: Dnipropetrovsk
country: Ukraine
facility: CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
city: Lviv
country: Ukraine
facility: Lviv State Oncological Regional Treatment and Diagnostic Center
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Kings Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ascierto PA, Lewis KD, Di Giacomo AM, Demidov L, Mandala M, Bondarenko I, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Simmons B, Ye C, Hooper G, Wongchenko MJ, Goodman GR, Yan Y, Schadendorf D. Prognostic impact of baseline tumour immune infiltrate on disease-free survival in patients with completely resected, BRAFv600 mutation-positive melanoma receiving adjuvant vemurafenib. Ann Oncol. 2020 Jan;31(1):153-159. doi: 10.1016/j.annonc.2019.10.002.
citation: Maio M, Lewis K, Demidov L, Mandala M, Bondarenko I, Ascierto PA, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Goodman GR, Simmons B, Ye C, Yan Y, Schadendorf D; BRIM8 Investigators. Adjuvant vemurafenib in resected, BRAFV600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):510-520. doi: 10.1016/S1470-2045(18)30106-2. Epub 2018 Feb 21.