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

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Vemurafenib
Cobimetinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring 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, melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • Consent to undergo tumor biopsies for biomarker analyses
  • Life expectancy greater than or equal to (≥) 12 weeks
  • Adequate hematologic and end organ function

Exclusion Criteria:

  • 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
  • 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:

    1. All known CNS lesions have been treated with stereotactic therapy or surgery, AND
    2. 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

Sites / Locations

  • University of Alabama at Birmingham
  • The Angeles Clinic and Research Institute - W LA Office
  • University of California Davis Health System
  • Sutter Pacific Medical Foundation
  • University Of Colorado
  • Florida Cancer Specialists - Broadway
  • Mount Sinai Medical Center
  • Orlando Health Inc.
  • Northwestern Center For Clinical Research
  • Uni of Kansas Medical Center; Dept of Neurology
  • U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology
  • Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
  • Dartmouth-Hitchcock Medical Center; Department of Medicine
  • Novant Health Oncology Specialists
  • University Hospitals of Cleveland
  • St. Luke's University Health network
  • Thomas Jefferson University Hospital
  • University of Pittsburgh
  • Rhode Island Hospital; Investigational Services
  • Vanderbilt University Medical Center
  • Chris O'Brien Lifehouse
  • Lake Macquarie Private Hospital
  • Lismore Base Hospital; Cancer Care & Haematology Unit
  • Melanoma Institute Australia
  • Princess Alexandra Hospital
  • Royal Darwin Hospital
  • Greenslopes Private Hospital
  • Royal Brisbane and Women's Hospital
  • Royal Adelaide Hospital; Hepatology
  • Ashford Cancer Centre
  • Royal Hobart Hospital
  • Launceston General Hospital; Gastroenterology Research
  • Peninsula and South Eastern Haematology and Oncology Group
  • Austin Hospital
  • Peter MacCallum Cancer Centre-East Melbourne
  • The Alfred Hospital
  • Fiona Stanley Hospital
  • Ordensklinikum Linz Elisabethinen
  • Landesklinikum St. Pölten
  • Medizinische Universität Wien
  • Institut Jules Bordet; Department of Medical Oncology
  • Cliniques Universitaires St-Luc
  • UZ Antwerpen
  • Jessa Zkh (Campus Virga Jesse)
  • CHU Sart-Tilman
  • AZ Delta (Campus Rumbeke)
  • BC Cancer Agency Vancouver Island Cancer Centre
  • Juravinski Cancer Clinic; Department of Oncology
  • The Ottawa Hospital Cancer Center; General Campus
  • Toronto Sunnybrook Hospital
  • Princess Margaret Hospital; Department of Med Oncology
  • London Health Sciences Centre · Victoria Hospital;Department of Pediatrics
  • McGill University Health Centre/Glen Site / Royal Victoria Hospital
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Hradec Kralove
  • Fakultní nemocnice Olomouc
  • Fakultni nemocnice Ostrava
  • Multiscan s.r.o.
  • Nemocnice Na Bulovce
  • Vseobecna fakultni nemocnice v Praze
  • Fakultni nemocnice Kralovske Vinohrady
  • Fakultni nemocnice Motol; Neurologicka klinika
  • Groupe Hospitalier Saint André - Hôpital Saint André
  • Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory
  • CHU Clermont Ferrand - Hôpital d'Estaing
  • CHU de Dijon - Hopital le Bocage
  • Centre Hospitalier Universitaire de Grenoble - Albert Michallon
  • Hopital Claude Huriez - CHU Lille
  • Hopital de la Timone
  • Hopital Saint Eloi
  • CHU NANTES - Hôtel Dieu; Pharmacy
  • CHU Nice - Hopital de l'Archet 2
  • Centre Hospitalier Lyon Sud
  • Hopital Robert Debre; DERMATOLOGIE
  • Centre Eugene Marquis; Service d'oncologie
  • St. Josef-Hospital; Studienambulanz
  • Elbekliniken Buxtehude GmbH
  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
  • Helios Klinikum Erfurt
  • Universitätsklinikum Essen
  • Universitaetsklinikum Freiburg
  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
  • Universitätsmedizin Göttingen
  • Universitätsklinikum Hamburg-Eppendorf
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Heidelberg
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin
  • Universitaetsklinikum Koeln; Hematology/Oncology
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Klinikum Mannheim GmbH Universitätsklinikum
  • Fachklinik Hornheide
  • Klinikum der Ludwigs-Maximilians-Universitaet Muenchen
  • Universitaetsklinikum Regensburg
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Wurzburg
  • Orszagos Onkologiai Intezet
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
  • Soroka Medical Center; Oncology Dept
  • Rambam Health Care Campus
  • HADASSAH UNIVERSITY HOSPITAL, EIN KAREM; Oncology
  • Rabin Medical Center-Beilinson Campus;Hematology-Oncology
  • Chaim Sheba Medical Center
  • Tel Aviv Sourasky MC, Dana children's hospital;Oncology Division
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
  • A.O.U. Policlinico di Modena
  • Istituto Nazionale Tumori Regina Elena IRCCS
  • Istituto Nazionale per la Ricerca sul Cancro di Genova
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
  • Asst Degli Spedali Civili Di Brescia
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
  • A.O.U. Senese Policlinico Santa Maria Alle Scotte
  • IOV - Istituto Oncologico Veneto IRCCS
  • Amsterdam UMC Location VUMC
  • Leids Universitair Medisch Centrum; Cardiology
  • Maastricht University Medical Center
  • Auckland City Hospital
  • Waikato Hospital
  • Radiumhospitalet
  • TSBHI Altai Territorial oncological dispensary
  • FSBSI "N. N. Blokhin Russian Cancer Research Center"
  • Moscow city oncology hospital #62 of Moscow Healthcare Department
  • BHI of Omsk region Clinical Oncology Dispensary
  • Pyatigorsky Oncologic Dispensary
  • Complexo Hospitalario Universitario de Santiago
  • Clinica Universitaria de Navarra
  • Hospital Universitario Virgen Macarena
  • Hospital Clínic i Provincial de Barcelona
  • MD Anderson Cancer Center
  • Hospital Universitario 12 de Octubre
  • Hospital General Universitario de Valencia
  • Hospital Universitario Miguel Servet
  • Länssjukhuset Ryhov
  • Skånes Universitetssjukhus
  • Sahlgrenska Sjukhuset
  • Akademiska Sjukhuset
  • Inselspital-Universitaetsspital Bern
  • Kantonsspital Graubuenden
  • Bristol Haematology and Oncology Centre
  • Addenbrooke's Hospital
  • Velindre Cancer Centre
  • Western General Hospital
  • Beatson West of Scotland Cancer Centre
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Barts and the London NHS Trust.
  • St George's Hospital; Courtyard Clinic
  • Royal Marsden Hospital - Fulham
  • Royal Marsden Hospital - London
  • Freeman Hospital
  • Nottingham University Hospitals; QMC Campus
  • Southampton General Hospital
  • Royal Cornwall Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Placebo + Vemurafenib

Cobimetinib + Vemurafenib

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 18, 2012
Last Updated
April 1, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01689519
Brief Title
A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma
Acronym
coBRIM
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2013 (Actual)
Primary Completion Date
May 9, 2014 (Actual)
Study Completion Date
July 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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 investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
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, melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
495 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + Vemurafenib
Arm Type
Active Comparator
Arm Description
Participants 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.
Arm Title
Cobimetinib + Vemurafenib
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo supplied as tablets
Intervention Type
Drug
Intervention Name(s)
Vemurafenib
Other Intervention Name(s)
RO518426
Intervention Description
Vemurafenib supplied as tablets
Intervention Type
Drug
Intervention Name(s)
Cobimetinib
Other Intervention Name(s)
GDC-0973, RO5514041, XL518
Intervention Description
Cobimetinib supplied as tablets
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
Time Frame
Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time from randomization until the date of death from any cause.
Time Frame
Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)
Title
Percentage of Participants With an Objective Response
Description
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.
Time Frame
Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)
Title
Duration of Response
Description
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.
Time Frame
Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Consent to undergo tumor biopsies for biomarker analyses Life expectancy greater than or equal to (≥) 12 weeks Adequate hematologic and end organ function Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
The Angeles Clinic and Research Institute - W LA Office
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
University of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sutter Pacific Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Florida Cancer Specialists - Broadway
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Orlando Health Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Northwestern Center For Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Uni of Kansas Medical Center; Dept of Neurology
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7314
Country
United States
Facility Name
U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center; Department of Medicine
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
St. Luke's University Health network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Rhode Island Hospital; Investigational Services
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
2903
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Lake Macquarie Private Hospital
City
Gateshead
State/Province
New South Wales
ZIP/Postal Code
2290
Country
Australia
Facility Name
Lismore Base Hospital; Cancer Care & Haematology Unit
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
Facility Name
Melanoma Institute Australia
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal Darwin Hospital
City
Casuarina
State/Province
Northern Territory
ZIP/Postal Code
0811
Country
Australia
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital; Hepatology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Ashford Cancer Centre
City
Ashford SA
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Launceston General Hospital; Gastroenterology Research
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Peninsula and South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Peter MacCallum Cancer Centre-East Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
The Alfred Hospital
City
Prahan
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Ordensklinikum Linz Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Landesklinikum St. Pölten
City
St. Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Institut Jules Bordet; Department of Medical Oncology
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Delta (Campus Rumbeke)
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
BC Cancer Agency Vancouver Island Cancer Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Juravinski Cancer Clinic; Department of Oncology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
The Ottawa Hospital Cancer Center; General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Toronto Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital; Department of Med Oncology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
London Health Sciences Centre · Victoria Hospital;Department of Pediatrics
City
London
State/Province
Quebec
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
McGill University Health Centre/Glen Site / Royal Victoria Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Multiscan s.r.o.
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Prague
ZIP/Postal Code
180 01
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Fakultni nemocnice Motol; Neurologicka klinika
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Groupe Hospitalier Saint André - Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory
City
Boulogne Billancourt
ZIP/Postal Code
92104
Country
France
Facility Name
CHU Clermont Ferrand - Hôpital d'Estaing
City
Clermont Ferrand cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
CHU de Dijon - Hopital le Bocage
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble - Albert Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital Claude Huriez - CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU NANTES - Hôtel Dieu; Pharmacy
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Nice - Hopital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Robert Debre; DERMATOLOGIE
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Eugene Marquis; Service d'oncologie
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
St. Josef-Hospital; Studienambulanz
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Elbekliniken Buxtehude GmbH
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Koeln; Hematology/Oncology
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Klinikum Mannheim GmbH Universitätsklinikum
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Fachklinik Hornheide
City
Muenster
ZIP/Postal Code
48157
Country
Germany
Facility Name
Klinikum der Ludwigs-Maximilians-Universitaet Muenchen
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Universitaetsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Wurzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Soroka Medical Center; Oncology Dept
City
Beer Sheva
ZIP/Postal Code
8410100
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109600
Country
Israel
Facility Name
HADASSAH UNIVERSITY HOSPITAL, EIN KAREM; Oncology
City
Jerusalem
ZIP/Postal Code
9112000
Country
Israel
Facility Name
Rabin Medical Center-Beilinson Campus;Hematology-Oncology
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky MC, Dana children's hospital;Oncology Division
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
A.O.U. Policlinico di Modena
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
40124
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro di Genova
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
Asst Degli Spedali Civili Di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
City
Bari
State/Province
Puglia
ZIP/Postal Code
70126
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria Alle Scotte
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto IRCCS
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Amsterdam UMC Location VUMC
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum; Cardiology
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3248
Country
New Zealand
Facility Name
Radiumhospitalet
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
TSBHI Altai Territorial oncological dispensary
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
FSBSI "N. N. Blokhin Russian Cancer Research Center"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow city oncology hospital #62 of Moscow Healthcare Department
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
BHI of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Pyatigorsky Oncologic Dispensary
City
Pyatigorsk
ZIP/Postal Code
357524
Country
Russian Federation
Facility Name
Complexo Hospitalario Universitario de Santiago
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Seville
State/Province
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Länssjukhuset Ryhov
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Facility Name
Skånes Universitetssjukhus
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Sahlgrenska Sjukhuset
City
Mölnlycke
ZIP/Postal Code
435 33
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Inselspital-Universitaetsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital Graubuenden
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L7 8YA
Country
United Kingdom
Facility Name
Barts and the London NHS Trust.
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
St George's Hospital; Courtyard Clinic
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Fulham
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital - London
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham University Hospitals; QMC Campus
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36310331
Citation
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.
Results Reference
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PubMed Identifier
34158360
Citation
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.
Results Reference
derived
PubMed Identifier
32746839
Citation
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.
Results Reference
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PubMed Identifier
28646893
Citation
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.
Results Reference
derived
PubMed Identifier
28444112
Citation
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.
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PubMed Identifier
27480103
Citation
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.
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PubMed Identifier
25265494
Citation
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.
Results Reference
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Learn more about this trial

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

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