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AzTrials

MelanomaPhase 3BRIM8NCT01667419

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

A Phase 3 study testing Vemurafenib in people with Melanoma, run by Hoffmann-La Roche at 207 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Vemurafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
498 participants
Where
207 sitesin 29 countries
Study dates
24 Sep 2012to 13 Jul 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

207 sites in 29 countries.

207 sites in 29 countries

United States47 sites

  • University Of Colorado

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • UCLA Department of Medicine; Division of Hematology / Oncology

    California City, California, 90095

  • MUSC Hollings Cancer Center/cannon Park Place; Attn: Tamara Saunders

    Charleston, South Carolina, 29425

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center; Oncology

    Durham, North Carolina, 27710

  • Florida Cancer Specialists - Broadway

    Fort Myers, Florida, 33901

  • West Clinic

    Germantown, Tennessee, 38138

  • Indiana University Health; Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • St. Mary's Hospital Regional Cancer Center

    Grand Junction, Colorado, 81501

  • Kaiser Permanente - Hayward

    Hayward, California, 94545

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Department of Medicine; Division of Infectious Diseases

    Indianapolis, Indiana, 46202

  • UCLA Hematology Oncology - Irvine

    Irvine, California, 92604

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • University of Kansas Medical Center; Cancer Center

    Kansas City, Missouri, 64131

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • The Angeles Clinic and Research Institute - W LA Office

    Los Angeles, California, 90025

  • Cancer Center Of Santa Barbara; Network Clinical Research Specialist

    Los Angeles, California, 90095

  • TRIO-US Network Administration; Network Clinical Research Specialist

    Los Angeles, California, 90095

  • U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology

    Louisville, Kentucky, 40202

  • Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

  • Tennessee Oncology PLLC - Nashville (20th Ave)

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • New York University Medical Center PRIME; NYU Clinical Cancer Center

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Kaiser Foundation Hospital - Oakland (W. MacArthur)

    Oakland, California, 94611

  • Kaiser Permanente - Oakland

    Oakland, California, 94611

  • Oncology Specialists, S.C.

    Park Ridge, Illinois, 60068

  • UCLA Healthcare/Pasadena Oncology

    Pasadena, California, 91105

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Atlantic Health Systems; Pediatrics

    Randolph Township, New Jersey, 07869

  • Kaiser Permanente - Roseville

    Roseville, California, 95661

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95814

  • Kaiser Permanente

    San Francisco, California, 94115

  • K. Permanente - San Jose

    San Jose, California, 95119

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Kaiser Permanente - Santa Clara

    Santa Clara, California, 95051

  • GulfCoast Oncology

    Sarasota, Florida, 34232

  • Kaiser Permanente - South San Francisco

    South San Francisco, California, 94080

  • Washington University; Dept of Medicine/Div of Medical Oncology

    St Louis, Missouri, 63110

  • Stanford University School of Medicine; Stanford Hospital Pharmacy

    Stanford, California, 94305

  • UCLA Cancer Center Hema/Oncol

    Valencia, California, 91355

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California, 94596

  • UCLA Hematology Oncology - Westlake

    Westlake Village, California, 91361

Other trials in United States

Australia15 sites

  • Royal Adelaide Hospital; Hepatology

    Adelaide, South Australia, 5000

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Cairns Base Hospital

    Cairns, Queensland, 4870

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Peninsula Oncology Centre; Frankston Private

    Frankston, Victoria, 3199

  • Launceston General Hospital; Gastroenterology Research

    Launceston, Tasmania, 7250

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Melanoma Institute Australia

    North Sydney, New South Wales, 2060

  • The Townsville Hospital; Townsville Cancer Centre

    Townsville, Queensland, 4812

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Border Medical Oncology

    Wodonga, New South Wales, 3690

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

  • Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Italy13 sites

  • Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari

    Bari, Apulia, 70126

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

    Bergamo, Lombardy, 24127

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25100

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    Genoa, Liguria, 16132

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, Lazio, 00133

  • Istituto Nazionale Tumori Regina Elena IRCCS

    Rome, Lazio, 00144

  • IDI-Istituto Dermopatico dell'Immacolata IRCCS

    Rome, Lazio, 00167

  • IRCCS Istituto Clinico Humanitas; Farmacia

    Rozzano, Lombardy, 20089

  • A.O.U. Senese Policlinico Santa Maria Alle Scotte

    Siena, Tuscany, 53100

Other trials in Italy

Germany12 sites

  • St. Josef-Hospital Universitaetsklinikum

    Bochum, 44791

  • Elbekliniken Buxtehude GmbH

    Buxtehude, 21614

  • Universitätsklinikum Koeln

    Cologne, 50937

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60528

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin

    Kiel, 24105

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke

    Mainz, 55131

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167

  • Fachklinik Hornheide

    Münster, 48157

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

France11 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • Groupe Hospitalier Saint André - Hôpital Saint André

    Bordeaux, 33075

  • Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory

    Boulogne-Billancourt, 92104

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037

  • Hopital de la Timone

    Marseille, 13005

  • CHU NANTES - Hôtel Dieu; Pharmacy

    Nantes, 44093

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202

  • Hôpital Saint-Louis

    Paris, 75475

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Rouen Hopital; Service de Neurologie

    Rouen, 76031

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31059

Other trials in France

Canada10 sites

  • LHSC - Victoria Hospital; Department of Pediatrics

    London, Ontario, N6A 4G5

  • CHUM Hôpital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Mcgill University - Royal Victoria Hospital; Oncology

    Montreal, Quebec, H3A 1A1

  • The Ottawa Hospital Cancer Center; General Campus

    Ottawa, Ontario, K1H 1C4

  • Saint John Regional Hospital; Department of Oncology

    Saint John, New Brunswick, E2L 4L2

  • CHUQ - Hôtel-Dieu de Québec

    Ste-Foy, Quebec, G1V 4G2

  • Toronto Sunnybrook Hospital

    Toronto, Ontario, M4N3M50

  • Princess Margaret Hospital; Department of Med Oncology

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • Saint Boniface General Hospital; Section of Nephrology BG 007

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

United Kingdom10 sites

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Queen Elizabeth Hospital

    Kings Lynn, PE30 4ET

  • Guys and St Thomas NHS Foundation Trust, Guys Hospital

    London, SE1 9RT

  • Nottingham University Hospitals City Campus

    Nottingham, NG5 1PB

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Argentina7 sites

  • Fundación CIDEA

    Buenos Aires, C1425DTG

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma Buenos Aires, 1426

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1284AEB

  • Hospital Universitario Austral

    Derqui-Pilar, B1629ODT

  • Centro de Investigacion Pergamino SA

    Pergamino, B2700CPM

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

  • ISIS Clinica Especializada

    Santa Fe, S3000

Other trials in Argentina

Czechia7 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultní nemocnice Olomouc

    Olomouc, 775 20

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Nemocnice Na Bulovce

    Prague, 180 01

Other trials in Czechia

Belgium6 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • AZ Groeninge, Apotheek

    Kortrijk, 8500

Other trials in Belgium

Brazil6 sites

  • Trymed Clinical Research

    Belo Horizonte, Minas Gerais, 30150-281

  • Hospital de Caridade de Ijuí

    Ijuí, Rondônia, 98700-000

  • CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Clinica de Oncologia de Porto Alegre - CliniOnco

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050

Other trials in Brazil

Israel6 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Health Care Campus

    Haifa, 3109600

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Spain6 sites

  • Hospital de la Santa Creu; i Sant Pau

    Barcelona, 08025

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Costa del Sol; Servicio de Oncologia

    Marbella, Malaga, 29600

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

South Africa5 sites

  • GVI Rondebosch Oncology Centre

    Cape Town, 7700

  • Mary Potter Oncology Centre

    Groenkloof, 0181

  • Groote Schuur Hospital Radiation Oncology Department; Department of Radiation Oncology

    Observatory, 7925

  • University of Pretoria Oncology Department

    Pretoria, 0001

  • Sandton Oncology Medical Group

    Sandton, 2196

Other trials in South Africa

Austria4 sites

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Krankenanstalt Rudolfstiftung Wien

    Vienna, 1030

  • Medizinische Universität Wien

    Vienna, 1090

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

Croatia4 sites

  • General Hospital Pula

    Pula, 52100

  • General Hospital Varazdin

    Varaždin, 42000

  • Clinical Hospital Center Sestre Milosrdnice

    Zagreb, 10000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Ireland4 sites

  • Cork University Hospital

    Cork

  • Mater Private Hospital

    Dublin, 7

  • The Mater Misericordiae Hospital

    Dublin, 7

  • University College Hospital

    Galway

Other trials in Ireland

Mexico4 sites

  • Centro Oncologico Belenus

    Cuernavaca, 62290

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Centro Regiomontano de Investigación Clínica

    Monterrey, 64710

  • Sanatorio la Luz

    Morelia, 58260

Other trials in Mexico

Poland4 sites

  • SPZOZ MSW zWarmińsko-MazurskimCen.Onko.wOlsztynie

    Olsztyn, 10-228

  • Przychodnia Med-Polonia Sp. z o.o.

    Poznan, 60-693

  • Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie

    Warsaw, 02-781

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, 53-439

Other trials in Poland

Portugal4 sites

  • IPO de Coimbra; Servico de Oncologia Medica

    Coimbra, 3000-075

  • Hospital do Espirito Santo; Servico de Oncologia Medica

    Evora, 7000-811

  • Hospital de Santa Maria; Servico de Oncologia Medica

    Lisbon, 1649-035

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Russia4 sites

  • Krasnodar City Oncology Center

    Krasnodar, 350040

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

    Moscow, 115478

  • Scientific Research Oncology Institute named after N.N. Petrov

    Saint Petersburg, 197758

Other trials in Russia

Serbia4 sites

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11040

  • Clinical Center Bezanijska Kosa

    Belgrade, 11070

  • Institute for oncology of Vojvodina

    Kamenitz, 21204

Other trials in Serbia

Estonia3 sites

  • East Tallinn Central Hospital; Clinic of Internal Medicine

    Tallinn, 11312

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital; Clinic of Hematology and Oncology

    Tartu, 50406

Other trials in Estonia

Sweden3 sites

  • Länssjukhuset Ryhov

    Jönköping, 551 85

  • Norrlands Universitetssjukhus

    Umeå, 901 850

  • Centrallasarettet Växjö

    Vaxjo, 351 85

Other trials in Sweden

Netherlands2 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Leids Universitair Medisch Centrum; Cardiology

    Leiden, 2333 ZA

Other trials in Netherlands

New Zealand2 sites

  • Christchurch Hospital NZ

    Christchurch, 8011

  • Wellington Hospital

    Wellington, 6012

Other trials in New Zealand

Ukraine2 sites

  • CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

    Dnipropetrovsk, 49102

  • Lviv State Oncological Regional Treatment and Diagnostic Center

    Lviv, 79031

Other trials in Ukraine

Norway1 site

  • Stavanger Universitetssykehus, Helse Stavanger HF

    Stavanger, 4011

Other trials in Norway

Switzerland1 site

  • CHUV; Departement d'Oncologie

    Lausanne, 1011

Other trials in Switzerland

About this study

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

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.

Conditions
Melanoma
Being tested
Vemurafenib, Placebo
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VemurafenibDrug

    Also called RO5185426/F17, Zelboraf

    4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.

  • PlaceboDrug

    Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.

Study groups in NCT01667419
Study groupRoleWhat they receive
Cohort 1 VemurafenibExperimentalParticipants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 milligrams (mg) twice daily, in 28-day cycles, for up to 52 weeks
Receives: Drug: Vemurafenib
Cohort 1 PlaceboPlacebo comparatorParticipants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Receives: Drug: Placebo
Cohort 2 VemurafenibExperimentalParticipants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Receives: Drug: Vemurafenib
Cohort 2 PlaceboPlacebo comparatorParticipants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)

    DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.

    Measured: 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 (5)

  1. Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT

    DMFS was defined as the time from randomization until the date of diagnosis of distant (i.e. non-locoregional) metastases or death from any cause.

    Measured: 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)

  2. Overall Survival (OS)

    OS is defined as the time from randomization until the date of death from any cause.

    Measured: From randomization until the date of death from any cause (up until 13-July-2018, approximately 6 years)

  3. Percentage of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.

    Measured: From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years)

  4. Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score

    European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).

    Measured: 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)

  5. Plasma Concentration of Vemurafenib

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2012 (estimated)
  2. Study start24 Sep 2012
  3. Primary completion23 Jun 2017
  4. Study completion13 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
498 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01667419
Sponsor's protocol ID
GO27826
Other IDs
2011-004011-24
Acronym
BRIM8
Status last verified
Jul 2019
First submitted
15 Aug 2012
Last updated
23 Jul 2019

Publications

  • 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.

    PubMed 31912791

  • 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.

    PubMed 29477665

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vemurafenib in people with Melanoma, run by Hoffmann-La Roche at 207 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in United States, Australia, Italy, Germany, France and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01667419, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.

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