Melanoma Clinical Trial

A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma

Summary

This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Females of child bearing potential and males with female partners must and use of contraceptive methods with a failure rate of less than or equal to ( Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma
Naive to prior systemic anti-cancer therapy for melanoma (example: chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or other biologic therapies) except adjuvant treatment with interferon (IFN), interleukin (IL)-2, or vaccine therapies or herbal therapies
Documentation of BRAFv600 mutation-positive status in melanoma tumor tissue (archival or newly obtained) through use of a clinical mutation test approved by the local health authority
Eastern Cooperative Oncology Group Performance (ECOG) Status of 0 or 1
Measurable disease according to RECIST v1.1 (must be outside central nervous system (CNS))
Life expectancy >/=18 weeks
For participants not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to ( For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment

Exclusion Criteria:

Cancer-Related Exclusion Criteria:

Major surgical procedure within 4 weeks prior study treatment initiation
Traumatic injury or palliative radiotherapy within 2 weeks prior study treatment initiation
Active malignancy (other than BRAFv600 mutation-positive melanoma) or malignancy within 3 years prior to screening are excluded, with the exception of resected melanoma, resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, limited-stage bladder cancer, or any other curatively treated malignancies from which the participant has been disease-free for at least 3 years

Ocular Exclusion Criteria:

History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration

Cardiac Exclusion Criteria:

History of clinically significant cardiac dysfunction
Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50%

Central Nervous System (CNS) Exclusion Criteria:

Untreated or actively progressing CNS lesions (carcinomatous meningitis)
History of metastases to brain stem, midbrain, pons, or medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm); or leptomeningeal metastatic disease; or intracranial hemorrhage

Additional Exclusion Criteria:

Uncontrolled diabetes or symptomatic hyperglycemia
Current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular, pulmonary, or renal disease) other than cancer
History of malabsorption or other clinically significant metabolic dysfunction
Pregnant or breastfeeding, or intending to become pregnant during the study
Prior allogeneic stem cell or solid organ transplantation
History of idiopathic pulmonary fibrosis, organizing pneumonia (example: bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Active or history of autoimmune disease or immune deficiency
Known clinically significant liver disease, inherited liver disease and active viral disease
Active tuberculosis
Treatment with therapeutic oral or intravenous (IV) antibiotics; or with a live, attenuated vaccine; or systemic immunosuppressive medication
Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab, cobimetinib, or vemurafenib formulations
Any grade >/=3 hemorrhage or bleeding event within 4 weeks prior to initiation of study treatment
History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to initiation of study treatment

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

514

Study ID:

NCT02908672

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 114 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
Arizona Oncology Associates, PC - HAL
Tempe Arizona, 85284, United States
Highlands Oncology Group
Springdale Arkansas, 72762, United States
UC Irvine Medical Center
Orange California, 92868, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
UF Health Cancer Center at Orlando Health
Orlando Florida, 32824, United States
Oncology Specialists, S.C.
Park Ridge Illinois, 60068, United States
St. Luke's University Health network
Bethlehem Pennsylvania, 18015, United States
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Peter Maccallum Cancer Centre
Melbourne Victoria, 3000, Australia
Fiona Stanley Hospital
Murdoch Western Australia, 6150, Australia
Medical University of Graz, Department of Dermatology
Graz , 8030, Austria
LKH Innsbruck; Universitätsklinik für Dermatologie
Innsbruck , 6020, Austria
Medizinische Universität Wien; Univ.Klinik für Dermatologie
Wien , 1090, Austria
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Sint Augustinus Wilrijk
Wilrijk , 2610, Belgium
Clinicas Oncologicas Integradas - COI
Rio De Janeiro RJ, 22290, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianopolis SC, 88034, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo SP, 01321, Brazil
Tom Baker Cancer Centre-Calgary
Calgary Alberta, T2N 4, Canada
Juravinski Cancer Clinic; Department of Oncology
Hamilton Ontario, L8V 5, Canada
LHSC - Victoria Hospital; London Regional Cancer Program
London Ontario, N6A 4, Canada
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa Ontario, K1H 8, Canada
Princess Margaret Hospital
Toronto Ontario, M4X 1, Canada
Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus
Quebec City Quebec, G1J 1, Canada
Groupe Hospitalier Saint André - Hôpital Saint André
Bordeaux , 33075, France
Hopital du Bocage; Dermatologie
Dijon , 21079, France
Centre Hospitalier Universitaire de Grenoble - Albert Michallon
La Tronche , 38700, France
Hopital Claude Huriez - CHU Lille
Lille , 59037, France
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
Montpellier , 34295, France
CHU de Nantes; Cancéro-dermatologie
Nantes , 44093, France
Hopital Robert Debre; DERMATOLOGIE
Reims , 51092, France
Centre Eugene Marquis; Service d'oncologie
Rennes , 35042, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen , 76031, France
Institut Gustave Roussy; Dermatologie
Villejuif , 94805, France
Charite - Universitätsmedizin Berlin
Berlin , 12203, Germany
Elbekliniken Buxtehude; Klinik für Dermatologie
Buxtehude , 21614, Germany
HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie
Erfurt , 99089, Germany
Universitätsklinikum Erlangen; Hautklinik
Erlangen , 91054, Germany
Universitatsklinikum Essen; Klinik für Dermatologie
Essen , 45147, Germany
Universitätsmedizin Göttingen
Göttingen , 37075, Germany
Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
Hannover , 30625, Germany
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
Heidelberg , 69120, Germany
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
Kiel , 24105, Germany
Klinikum d.Universität zu Köln Klinik u.Poliklinik f.Dermatologie
Köln , 50937, Germany
Universitätsklinikum Leipzig; Klinik für Dermatologie, Venerologie und Allergologie
Leipzig , 04103, Germany
UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d
Lübeck , 23538, Germany
Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie
Mainz , 55131, Germany
Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie
München , 80337, Germany
Fachklinik Hornheide; Dermatologie
Münster , 48157, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz
Quedlinburg , 06484, Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
Regensburg , 93053, Germany
Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen
Tübingen , 72076, Germany
Universitätsklinikum Würzburg; Med. Klinik 1, Pneumologie
Würzburg , 97080, Germany
Laiko General Hospital Athen
Athens , 115 2, Greece
Metropolitan Hospital; Dept. of Oncology
Pireaus , 185 4, Greece
Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly
Budapest , 1122, Hungary
University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology
Szeged , 6720, Hungary
Rambam Health Care Campus; Oncology
Haifa , 31096, Israel
Sharett Institute - Hadassah Hebrew University Medical Center
Jerusalem , 91120, Israel
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva , 49414, Israel
Ella Institute - Sheba Medical Center
Ramat-Gan , 52656, Israel
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
Napoli Campania, 80131, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Udine Friuli-Venezia Giulia, 33100, Italy
IFO - Istituto Regina Elena; Oncologia Medica
Roma Lazio, 00144, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genova Liguria, 16132, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano Lombardia, 20133, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milano Lombardia, 20141, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo Piemonte, 10060, Italy
Istituto Tumori "Giovanni Paolo II", Oncologia
Bari Puglia, 70124, Italy
A.O.U. Senese Policlinico Santa Maria Alle Scotte
Siena Toscana, 53100, Italy
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
Rotterdam , 3015A, Netherlands
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland , 1023, New Zealand
Wellington Hospital; Wellington Blood and Cancer Centre
Newtown , 6021, New Zealand
Mid Central DHB
Palmerston North , 4442, New Zealand
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
Tauranga , 3112, New Zealand
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk , 80-21, Poland
Narodowy Inst.Onkol.im.Skłodowskiej-Curie Państw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej
Kraków , 31-11, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin , 20-09, Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.
Poznań , 60-78, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warszawa , 02-78, Poland
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
Wrocław , 53-41, Poland
IPO de Lisboa; Servico de Oncologia Medica
Lisboa , 1099-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow , 11547, Russian Federation
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint-Petersburg , , Russian Federation
St. Petersburg Oncology Hospital
St Petersburg , 19825, Russian Federation
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona , 08036, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Universitario Virgen de la Macarena;
Sevilla , 41071, Spain
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia , 46009, Spain
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia , 46014, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza , 50009, Spain
Bristol Haematology and Oncology Centre
Bristol , BS2 8, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Ipswich Hospital; Oncology Pharmacy
Ipswich , IP4 5, United Kingdom
St James Uni Hospital; Icrf Cancer Medicine Research Unit
Leeds , LS9 7, United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London , SE1 9, United Kingdom
Freeman Hospital; Northern Centre For Cancer Care
New Castle Upon Tyne , NE7 7, United Kingdom
Singleton Hospital; Pharmacy Department
Swansea , SA2 8, United Kingdom
Royal Cornwall Hospital
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

514

Study ID:

NCT02908672

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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