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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02908672
Recruitment Status : Active, not recruiting
First Posted : September 21, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Atezolizumab Drug: Atezolizumab Placebo Drug: Cobimetinib Drug: Vemurafenib Drug: Vemurafenib Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 513 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Actual Study Start Date : January 13, 2017
Estimated Primary Completion Date : October 9, 2019
Estimated Study Completion Date : July 29, 2023


Arm Intervention/treatment
Experimental: Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
Run-In Period (Cycle 1=28 days): Participants will receive vemurafenib 960 mg (four, 240 mg tablets) PO BID along with cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21 followed by vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 22 to 28 and vemurafenib placebo (1 tablet) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive atezolizumab 840 mg IV infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
Drug: Atezolizumab
Will be administered as per the schedule described in individual arm.

Drug: Cobimetinib
Will be administered as per the schedule described in individual arm.

Drug: Vemurafenib
Will be administered as per the schedule described in individual arm.

Drug: Vemurafenib Placebo
Will be administered as per the schedule described in individual arm.

Experimental: Atezolizumab Placebo + Cobimetinib + Vemurafenib
Run-In Period (Cycle1=28 days): Participants will receive vemurafenib 960 milligrams (mg) (four, 240 mg tablets) orally (PO) twice a day (BID) along with cobimetinib 60 mg (three, 20 mg tablets) PO once a day (QD) on Days 1 to 21 followed by vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive ATZ placebo by intravenous (IV) infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, and vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
Drug: Atezolizumab Placebo
Will be administered as per the schedule described in individual arm.

Drug: Cobimetinib
Will be administered as per the schedule described in individual arm.

Drug: Vemurafenib
Will be administered as per the schedule described in individual arm.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 90 months) ]

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS), as Determined by Independent Review Committee Using RECIST v1.1 [ Time Frame: Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 90 months) ]
  2. Percentage of Participants With Objective Response, as Determined by Investigator Using RECIST v1.1 [ Time Frame: Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 90 months) ]
  3. Duration of Response, as Determined by Investigator Using RECIST v1.1 [ Time Frame: Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 90 months) ]
  4. Overall Survival [ Time Frame: Baseline up to death due to any cause (up to approximately 90 months) ]
  5. Percentage of Participants who Have Survived at 2 Years [ Time Frame: 2 years ]
  6. Time to Deterioration in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Scale Score [ Time Frame: Baseline up to end of treatment (approximately 90 months) ]
  7. Time to Deterioration in Physical Functioning Using EORTC QLQ-C30 Physical Functioning Scale Score [ Time Frame: Baseline up to end of treatment (approximately 90 months) ]
  8. Percentage of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Baseline up to 6 months after the last dose of study treatment (approximately 90 months) ]
  9. Serum Concentration of Atezolizumab [ Time Frame: Pre-infusion Day 1 of Cycles 1-4; 30 minutes post-infusion Day 1 of Cycles 1 and 4; at Atezolizumab discontinuation (up to approximately 90 months)(1 Cycle = 28 days) ]
  10. Plasma Concentration of Cobimetinib [ Time Frame: Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cy 1 and 4 (1 Cy = 28 days) ]
  11. Plasma Concentration of Vemurafenib [ Time Frame: Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cy 1 and 4 (1 Cy = 28 days) ]
  12. Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab [ Time Frame: Pre-infusion Day 1 of Cycles 1-4; at Atezolizumab discontinuation (up to approximately 90 months)(1 Cycle=28 days) (approximately up to 90 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (</=)1% per year is required during treatment and for 6 months post treatment. Males should not expose pregnant partners to sperm and refrain from donating sperm for 6 months post treatment. Women must refrain from donating eggs during this same period
  • 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 (</=) 1.5*upper limit of normal (ULN) within 28 days prior to initiation of study treatment
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908672


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Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, United States, 85258
Arizona Oncology Associates, PC - HAL
Tempe, Arizona, United States, 85284
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
California Pacific Medical Center - Pacific Campus
San Francisco, California, United States, 94115
Stanford Comprehensive Cancer Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
Florida Cancer Specialists; SCRI
Fort Myers, Florida, United States, 33901
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States, 32824
United States, Illinois
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
United States, Missouri
Sarah Cannon Research Institute - Kansas City - HCA Midwest Health
Kansas City, Missouri, United States, 64132
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07962
United States, Pennsylvania
St. Luke's University Health network
Bethlehem, Pennsylvania, United States, 18015
Thomas Jefferson University Hospital;Medical Oncology
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology-Austin Midtown
Austin, Texas, United States, 78705
Rocky Mountain Cancer Centers, LLP
Irving, Texas, United States, 75063
Texas Oncology-Tyler
Irving, Texas, United States, 75063
Australia, New South Wales
Orange Hospital
Orange, New South Wales, Australia, 2800
Australia, Queensland
Townsville Hospital; Haematology and Oncology
Townsville, Queensland, Australia, 4810
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Austria
Medical University of Graz, Department of Dermatology
Graz, Austria, 8030
LKH Innsbruck; Universitätsklinik für Dermatologie
Innsbruck, Austria, 6020
Medizinische Universität Wien; Univ.Klinik für Dermatologie
Wien, Austria, 1090
Belgium
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
CHU Sart-Tilman
Liège, Belgium, 4000
Sint Augustinus Wilrijk
Wilrijk, Belgium, 2610
Brazil
Clinicas Oncologicas Integradas - COI
Rio De Janeiro, RJ, Brazil, 22290-160
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-003
Centro de Pesquisas Oncologicas - CEPON
Florianopolis, SC, Brazil, 88034-000
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Hospital Sao Jose
São Paulo, SP, Brazil, CEP 01321-001
Canada, Alberta
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Juravinski Cancer Clinic; Department of Oncology
Hamilton, Ontario, Canada, L8V 5C2
LHSC - Victoria Hospital; London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M4X 1K9
Canada, Quebec
CHU de Québec
Quebec City, Quebec, Canada, G1J 1Z4
France
Groupe Hospitalier Saint André - Hôpital Saint André
Bordeaux, France, 33075
Hopital Ambroise Pare; Sce Dermatologie
Boulogne-billancourt, France, 92100
Hopital du Bocage; Dermatologie
Dijon, France, 21079
Centre Hospitalier Universitaire de Grenoble - Albert Michallon
La Tronche, France, 38700
Hopital Claude Huriez - CHU Lille
Lille, France, 59037
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
Montpellier, France, 34295
CHU de Nantes; Cancéro-dermatologie
Nantes, France, 44093
CHU Nice - Hopital de l'Archet 2
Nice, France, 06202
Hopital Cochin; Dermatologie
Paris, France, 75006
Centre Hospitalier Lyon Sud; Dermatologie
Pierre Benite, France, 69495
Hopital Robert Debre; DERMATOLOGIE
Reims, France, 51092
Centre Eugene Marquis; Service d'oncologie
Rennes, France, 35042
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France, 76031
Service d'Oncologie, Institut Universitaire du Cancer de Toulouse
Toulouse, France, 31059
Institut Gustave Roussy; Dermatologie
Villejuif, France, 94805
Germany
Charite - Universitätsmedizin Berlin
Berlin, Germany, 12203
Elbekliniken Buxtehude; Klinik für Dermatologie
Buxtehude, Germany, 21614
HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie
Erfurt, Germany, 99089
Universitätsklinikum Erlangen; Hautklinik
Erlangen, Germany, 91054
Universitatsklinikum Essen; Klinik für Dermatologie
Essen, Germany, 45147
Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
Hannover, Germany, 30625
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
Heidelberg, Germany, 69120
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
Kiel, Germany, 24105
Klinikum d.Universität zu Köln Klinik u.Poliklinik f.Dermatologie
Köln, Germany, 50937
Universitätsklinikum Leipzig; Klinik für Dermatologie, Venerologie und Allergologie
Leipzig, Germany, 04103
UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d
Lübeck, Germany, 23538
Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz
Mainz, Germany, 55131
Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie
München, Germany, 80337
Fachklinik Hornheide; Dermatologie
Münster, Germany, 48157
Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
Nürnberg, Germany, 90419
Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz
Quedlinburg, Germany, 06484
Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
Regensburg, Germany, 93053
Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen
Tübingen, Germany, 72076
Universitätsklinikum Wurzburg
Würzburg, Germany, 97080
Greece
Laiko General Hospital Athen
Athens, Greece, 115 27
Metropolitan Hospital; Dept. of Oncology
Pireaus, Greece, 185 47
Hungary
Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly
Budapest, Hungary, 1122
University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology
Szeged, Hungary, 6720
Israel
Rambam Health Care Campus; Oncology
Haifa, Israel, 3109601
Sharett Institute - Hadassah Hebrew University Medical Center
Jerusalem, Israel, 9112001
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva, Israel, 4941492
Ella Institute - Sheba Medical Center
Ramat-Gan, Israel, 5265601
Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
Napoli, Campania, Italy, 80131
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy, 47014
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Udine, Friuli-Venezia Giulia, Italy, 33100
IFO - Istituto Regina Elena; Oncologia Medica
Roma, Lazio, Italy, 00144
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genova, Liguria, Italy, 16132
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano, Lombardia, Italy, 20133
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milano, Lombardia, Italy, 20141
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo, Piemonte, Italy, 10060
Istituto Tumori "Giovanni Paolo II", Oncologia
Bari, Puglia, Italy, 70124
A.O.U. Senese Policlinico Santa Maria Alle Scotte
Siena, Toscana, Italy, 53100
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center - Oncology
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 6351
Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, Netherlands, 9713 GZ
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
Rotterdam, Netherlands, 3015AA
Maxima Medisch Centrum; locatie Veldhoven
Veldhoven, Netherlands, 5504 DB
New Zealand
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, New Zealand, 1023
Wellington Hospital; Wellington Blood and Cancer Centre
Newtown, New Zealand, 6021
Mid Central DHB
Palmerston North, New Zealand, 4442
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
Tauranga, New Zealand, 3112
Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk, Poland, 80-214
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, Poland, 31-531
Klinika Onkologii Klinicznej CO-I Kraków
Krakow, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, Poland, 20-090
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.
Poznań, Poland, 60-780
Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
Warszawa, Poland, 02-781
Dolnoslaskie Centrum Onkologii
Wrocław, Poland, 53-413
Portugal
IPO de Lisboa; Servico de Oncologia Medica
Lisboa, Portugal, 1099-023
IPO do Porto; Servico de Oncologia Medica
Porto, Portugal, 4200-072
Russian Federation
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, Russian Federation, 115478
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint-Petersburg, Russian Federation
St. Petersburg Oncology Hospital
St Petersburg, Russian Federation, 198255
Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Asturias, Spain, 33011
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain, 15706
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra, Spain, 31008
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, Spain, 08036
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Universitario Virgen de la Macarena;
Sevilla, Spain, 41071
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia, Spain, 41014
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia, Spain, 46009
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Ipswich Hospital; Oncology Pharmacy
Ipswich, United Kingdom, IP4 5PD
St James Uni Hospital; Icrf Cancer Medicine Research Unit
Leeds, United Kingdom, LS9 7TF
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, United Kingdom, SE1 9RT
Freeman Hospital; Northern Centre For Cancer Care
New Castle Upon Tyne, United Kingdom, NE7 7DN
Singleton Hospital; Pharmacy Department
Swansea, United Kingdom, SA2 8QA
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LQ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02908672     History of Changes
Other Study ID Numbers: CO39262
2016-002482-54 ( EudraCT Number )
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Atezolizumab
Vemurafenib
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action