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Malignant MelanomaPhase 3coBRIMNCT01689519

A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

A Phase 3 study testing Vemurafenib and Cobimetinib in people with Malignant Melanoma, run by Hoffmann-La Roche at 156 sites in 19 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

To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
Vemurafenib and Cobimetinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
495 participants
Where
156 sitesin 19 countries
Study dates
8 Jan 2013to 21 Jul 2019
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

  • Participants with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition. Unresectability of stage IIIc disease must have confirmation from a surgical oncologist
  • Participants must be naïve to treatment for locally advanced unresectable or metastatic disease (ie, no prior systemic anti-cancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed
  • Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test
  • Measurable disease per RECIST v1.1
  • Eastern Clinical Oncology Group performance status of 0 or 1
  • Consent to provide archival for biomarker analyses
Show all 9Show fewer
  • Consent to undergo tumor biopsies for biomarker analyses
  • Life expectancy greater than or equal to (≥) 12 weeks
  • Adequate hematologic and end organ function

Who cannot join

  • History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment
  • Palliative radiotherapy within 14 days prior to the first dose of study treatment
  • Major surgery or traumatic injury within 14 days prior to first dose of study treatment
  • Active malignancy other than melanoma that could potentially interfere with the interpretation of efficacy measures. Participants with a previous malignancy within the past 3 years are excluded except for participants with resected basal cell carcinoma or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast
  • History of or evidence of retinal pathology on ophthalmological examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion, or neovascular macular degeneration
  • Uncontrolled glaucoma with intraocular pressure
Show all 16Show fewer
  • Serum cholesterol ≥ Grade 2
  • Hypertriglyceridemia ≥ Grade 2
  • Hyperglycemia (fasting) ≥ Grade 2
  • History of clinically significant cardiac dysfunction
  • Participants with active central nervous system (CNS) lesions (including carcinomatous meningitis) are excluded. However, participants are eligible if:
  • All known CNS lesions have been treated with stereotactic therapy or surgery, AND
  • There has been no evidence of clinical and radiographic disease progression in the CNS for ≥ 3 weeks after radiotherapy or surgery
  • Current severe, uncontrolled systemic disease
  • History of malabsorption or other condition that would interfere with absorption of study drugs
  • Pregnant, lactating, or breast feeding women

Trial locations and contacts

156 sites in 19 countries.

156 sites in 19 countries

United States20 sites

  • University Of Colorado

    Aurora, Colorado, 80045

  • St. Luke's University Health network

    Bethlehem, Pennsylvania, 18015

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Northwestern Center For Clinical Research

    Chicago, Illinois, 60611

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Florida Cancer Specialists - Broadway

    Fort Myers, Florida, 33901

  • Uni of Kansas Medical Center; Dept of Neurology

    Kansas City, Kansas, 66160-7314

  • Dartmouth-Hitchcock Medical Center; Department of Medicine

    Lebanon, New Hampshire, 03756

  • The Angeles Clinic and Research Institute - W LA Office

    Los Angeles, California, 90025

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

    Louisville, Kentucky, 40202

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Orlando Health Inc.

    Orlando, Florida, 32806

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

  • Rhode Island Hospital; Investigational Services

    Providence, Rhode Island, 2903

  • University of California Davis Health System

    Sacramento, California, 95817

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

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

    St Louis, Missouri, 63108

  • Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany20 sites

  • St. Josef-Hospital; Studienambulanz

    Bochum, 44791

  • Elbekliniken Buxtehude GmbH

    Buxtehude, 21614

  • Universitaetsklinikum Koeln; Hematology/Oncology

    Cologne, 50937

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

    Gera, 07548

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

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

    Kiel, 24105

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55101

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167

  • Klinikum der Ludwigs-Maximilians-Universitaet Muenchen

    München, 80337

  • Fachklinik Hornheide

    Münster, 48157

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Australia17 sites

  • Royal Adelaide Hospital; Hepatology

    Adelaide, South Australia, 5000

  • Ashford Cancer Centre

    Ashford SA, South Australia, 5035

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Royal Darwin Hospital

    Casuarina, Northern Territory, 0811

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Lake Macquarie Private Hospital

    Gateshead, New South Wales, 2290

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Launceston General Hospital; Gastroenterology Research

    Launceston, Tasmania, 7250

  • Lismore Base Hospital; Cancer Care & Haematology Unit

    Lismore, New South Wales, 2480

  • Peter MacCallum Cancer Centre-East Melbourne

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Melanoma Institute Australia

    North Sydney, New South Wales, 2060

  • The Alfred Hospital

    Prahan, Victoria, 3181

  • Princess Alexandra Hospital

    Woolloongabba, New South Wales, 2050

Other trials in Australia

United Kingdom15 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

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L7 8YA

  • Barts and the London NHS Trust.

    London, EC1A 7BE

  • St George's Hospital; Courtyard Clinic

    London, SW17 0QT

  • Royal Marsden Hospital - Fulham

    London, SW3 6JJ

  • Royal Marsden Hospital - London

    London, SW3 6JJ

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals; QMC Campus

    Nottingham, NG7 2UH

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

France13 sites

  • Groupe Hospitalier Saint André - Hôpital Saint André

    Bordeaux, 33075

  • Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory

    Boulogne-Billancourt, 92104

  • CHU Clermont Ferrand - Hôpital d'Estaing

    Clermont-Ferrand, 63003

  • CHU de Dijon - Hopital le Bocage

    Dijon, 21000

  • Centre Hospitalier Universitaire de Grenoble - Albert Michallon

    La Tronche, 38700

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037

  • Hopital de la Timone

    Marseille, 13005

  • Hopital Saint Eloi

    Montpellier, 34295

  • CHU NANTES - Hôtel Dieu; Pharmacy

    Nantes, 44093

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Robert Debre; DERMATOLOGIE

    Reims, 51092

  • Centre Eugene Marquis; Service d'oncologie

    Rennes, 35042

Other trials in France

Italy11 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

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

    Meldola, Emilia-Romagna, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

  • A.O.U. Policlinico di Modena

    Modena, Emilia-Romagna, 40124

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

  • Istituto Nazionale Tumori Regina Elena IRCCS

    Rome, Lazio, 00144

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

    Siena, Tuscany, 53100

Other trials in Italy

Czechia9 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

  • Multiscan s.r.o.

    Pardubice, 532 03

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Fakultni nemocnice Motol; Neurologicka klinika

    Prague, 150 06

  • Nemocnice Na Bulovce

    Prague, 180 01

Other trials in Czechia

Spain8 sites

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Complexo Hospitalario Universitario de Santiago

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41071

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Canada7 sites

  • Juravinski Cancer Clinic; Department of Oncology

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Centre · Victoria Hospital;Department of Pediatrics

    London, Quebec, N6A 4G5

  • McGill University Health Centre/Glen Site / Royal Victoria Hospital

    Montreal, Quebec, H2W 1S6

  • The Ottawa Hospital Cancer Center; General Campus

    Ottawa, Ontario, K1H 1C4

  • Toronto Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital; Department of Med Oncology

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Belgium6 sites

  • Institut Jules Bordet; Department of Medical Oncology

    Brussels, 1000

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, 2650

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • CHU Sart-Tilman

    Liège, 4000

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800

Other trials in Belgium

Israel6 sites

  • Soroka Medical Center; Oncology Dept

    Beersheba, 8410100

  • Rambam Health Care Campus

    Haifa, 3109600

  • HADASSAH UNIVERSITY HOSPITAL, EIN KAREM; Oncology

    Jerusalem, 9112000

  • Rabin Medical Center-Beilinson Campus;Hematology-Oncology

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Sourasky MC, Dana children's hospital;Oncology Division

    Tel Aviv, 6423906

Other trials in Israel

Russia5 sites

  • TSBHI Altai Territorial oncological dispensary

    Barnaul, 656045

  • FSBSI "N. N. Blokhin Russian Cancer Research Center"

    Moscow, 115478

  • Moscow city oncology hospital #62 of Moscow Healthcare Department

    Moscow, 143423

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • Pyatigorsky Oncologic Dispensary

    Pyatigorsk, 357524

Other trials in Russia

Hungary4 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

    Gyula, 5700

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Pécs, 7624

  • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

    Szeged, 6720

Other trials in Hungary

Sweden4 sites

  • Länssjukhuset Ryhov

    Jönköping, 551 85

  • Skånes Universitetssjukhus

    Lund, 221 85

  • Sahlgrenska Sjukhuset

    Mölnlycke, 435 33

  • Akademiska Sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Austria3 sites

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020

  • Landesklinikum St. Pölten

    Sankt Pölten, 3100

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Netherlands3 sites

  • Amsterdam UMC Location VUMC

    Amsterdam, 1081 HV

  • Leids Universitair Medisch Centrum; Cardiology

    Leiden, 2333 ZA

  • Maastricht University Medical Center

    Maastricht, 6229 HX

Other trials in Netherlands

New Zealand2 sites

  • Auckland City Hospital

    Auckland, 1023

  • Waikato Hospital

    Hamilton, 3248

Other trials in New Zealand

Switzerland2 sites

  • Inselspital-Universitaetsspital Bern

    Bern, 3010

  • Kantonsspital Graubuenden

    Chur, 7000

Other trials in Switzerland

Norway1 site

  • Radiumhospitalet

    Oslo, 0379

Other trials in Norway

About this study

Official title: A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.

Being tested
Placebo, Vemurafenib, Cobimetinib
Keywords
Zelboraf, vemurafenib, RG7204, PLX4032, Genentech MEK inhibitor, Genentech BRAF inhibitor, Roche MEK inhibitor, Roche BRAF inhibitor, RO5185426, metastatic melanoma, BRAF positive melanoma, BRAF mutant melanoma, advanced melanoma, Genentech RAF inhibitor, Roche RAF inhibitor, BRAF V600E kinase inhibitor, Oncogenic BRAF inhibitor, BRAF kinase inhibitor, GDC-0973, XL518
Medical subject headings
Melanoma

What participants receive

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

  • PlaceboDrug

    Placebo supplied as tablets

  • VemurafenibDrug

    Also called RO518426

    Vemurafenib supplied as tablets

  • CobimetinibDrug

    Also called GDC-0973, RO5514041, XL518

    Cobimetinib supplied as tablets

Study groups in NCT01689519
Study groupRoleWhat they receive
Placebo + VemurafenibActive comparatorParticipants will receive placebo orally once daily on Days 1-21 of each 28-day cycle plus vemurafenib 960 milligrams (mg) orally twice a day on Days 1-28 of each 28-day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
Receives: Drug: Placebo; Drug: Vemurafenib
Cobimetinib + VemurafenibExperimentalParticipants will receive cobimetinib 60 mg orally once daily on Days 1-21 of each 28-day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28-day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
Receives: Drug: Vemurafenib; Drug: Cobimetinib

What is being measured

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

  1. Progression-free Survival

    Progression-free survival was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using Response Evaluation Criteria in Solid Tumors v1.1, or death from any cause, whichever came first. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.

    Measured: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)

Secondary outcomes (3)

  1. Overall Survival

    Overall survival was defined as the time from randomization until the date of death from any cause.

    Measured: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)

  2. Percentage of Participants With an Objective Response

    An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors v1.1. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.

    Measured: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)

  3. Duration of Response

    Duration of response was defined as the time from first occurrence of a documented confirmed objective response until the time of disease progression, as determined by investigator review of tumor assessments using Response Evaluation Criteria in Solid Tumors v1.1 or death from any cause during the study. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.

    Measured: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)

Timeline

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

  1. First posted21 Sep 2012 (estimated)
  2. Study start8 Jan 2013
  3. Primary completion9 May 2014
  4. Study completion21 Jul 2019

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01689519
Sponsor's protocol ID
GO28141
Other IDs
2012-003008-11
Acronym
coBRIM
Status last verified
Apr 2022
First submitted
18 Sep 2012
Last updated
2 May 2022

Publications

  • Barteselli G, Goodman GR, Patel Y, Caro I, Xue C, McCallum S. Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies. Drug Saf. 2022 Dec;45(12):1491-1499. doi: 10.1007/s40264-022-01248-2. Epub 2022 Oct 30.

    PubMed 36310331

  • Ascierto PA, Dreno B, Larkin J, Ribas A, Liszkay G, Maio M, Mandala M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Atkinson V, Dutriaux C, Garbe C, Hsu J, Jones S, Li H, McKenna E, Voulgari A, McArthur GA. 5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation-Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study. Clin Cancer Res. 2021 Oct 1;27(19):5225-5235. doi: 10.1158/1078-0432.CCR-21-0809.

    PubMed 34158360

  • Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dreno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib +/- cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.

    PubMed 32746839

  • de la Cruz-Merino L, Di Guardo L, Grob JJ, Venosa A, Larkin J, McArthur GA, Ribas A, Ascierto PA, Evans JTR, Gomez-Escobar A, Barteselli G, Eng S, Hsu JJ, Uyei A, Dreno B. Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study. J Transl Med. 2017 Jun 24;15(1):146. doi: 10.1186/s12967-017-1246-0.

    PubMed 28646893

  • Dreno B, Ribas A, Larkin J, Ascierto PA, Hauschild A, Thomas L, Grob JJ, Koralek DO, Rooney I, Hsu JJ, McKenna EF, McArthur GA. Incidence, course, and management of toxicities associated with cobimetinib in combination with vemurafenib in the coBRIM study. Ann Oncol. 2017 May 1;28(5):1137-1144. doi: 10.1093/annonc/mdx040.

    PubMed 28444112

  • Ascierto PA, McArthur GA, Dreno B, Atkinson V, Liszkay G, Di Giacomo AM, Mandala M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Dutriaux C, Garbe C, Yan Y, Wongchenko M, Chang I, Hsu JJ, Koralek DO, Rooney I, Ribas A, Larkin J. Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 2016 Sep;17(9):1248-60. doi: 10.1016/S1470-2045(16)30122-X. Epub 2016 Jul 30.

    PubMed 27480103

  • Larkin J, Ascierto PA, Dreno B, Atkinson V, Liszkay G, Maio M, Mandala M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Dutriaux C, Garbe C, Sovak MA, Chang I, Choong N, Hack SP, McArthur GA, Ribas A. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014 Nov 13;371(20):1867-76. doi: 10.1056/NEJMoa1408868. Epub 2014 Sep 29.

    PubMed 25265494

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vemurafenib and Cobimetinib in people with Malignant Melanoma, run by Hoffmann-La Roche at 156 sites in 19 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 9 inclusion and 16 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Germany, Australia, United Kingdom, France and 14 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. 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 30 Oct 2015). 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?

Progression-free Survival (time frame: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)). 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 NCT01689519, which also lists 7 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 2 May 2022.

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