search
Back to results

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

Primary Purpose

Melanoma

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

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

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

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

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Oncology Associates, PC - HAL
  • Highlands Oncology Group
  • UC Irvine Medical Center
  • Mount Sinai Medical Center
  • UF Health Cancer Center at Orlando Health
  • Oncology Specialists, S.C.
  • St. Luke's University Health network
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Peter Maccallum Cancer Centre
  • Fiona Stanley Hospital
  • Medical University of Graz, Department of Dermatology
  • LKH Innsbruck; Universitätsklinik für Dermatologie
  • Medizinische Universität Wien; Univ.Klinik für Dermatologie
  • Cliniques Universitaires St-Luc
  • UZ Leuven Gasthuisberg
  • CHU Sart-Tilman
  • Sint Augustinus Wilrijk
  • Clinicas Oncologicas Integradas - COI
  • Hospital das Clinicas - UFRGS
  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Beneficencia Portuguesa de Sao Paulo
  • Tom Baker Cancer Centre-Calgary
  • Juravinski Cancer Clinic; Department of Oncology
  • LHSC - Victoria Hospital; London Regional Cancer Program
  • Lakeridge Health Oshawa; Oncology
  • The Ottawa Hospital Cancer Centre; Oncology
  • Princess Margaret Hospital
  • CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie
  • Groupe Hospitalier Saint André - Hôpital Saint André
  • Hopital du Bocage; Dermatologie
  • Centre Hospitalier Universitaire de Grenoble - Albert Michallon
  • Hopital Claude Huriez - CHU Lille
  • Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
  • CHU de Nantes; Cancéro-dermatologie
  • Hopital Robert Debre; DERMATOLOGIE
  • Centre Eugene Marquis; Service d'oncologie
  • CHU de Rouen - Hôpital Charles Nicolle
  • Institut Gustave Roussy; Dermatologie
  • Charite - Universitätsmedizin Berlin
  • Elbekliniken Buxtehude; Klinik für Dermatologie
  • HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie
  • Universitätsklinikum Erlangen; Hautklinik
  • Universitatsklinikum Essen; Klinik für Dermatologie
  • Universitätsmedizin Göttingen
  • Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
  • Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
  • UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
  • Klinikum d.Universität zu Köln Klinik u.Poliklinik f.Dermatologie
  • Universitätsklinikum Leipzig; Klinik für Dermatologie, Venerologie und Allergologie
  • UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d
  • Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie
  • Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie
  • Fachklinik Hornheide; Dermatologie
  • Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz
  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
  • Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen
  • Universitätsklinikum Würzburg; Med. Klinik 1, Pneumologie
  • Laiko General Hospital Athen
  • Metropolitan Hospital; Dept. of Oncology
  • Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly
  • University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology
  • Rambam Health Care Campus; Oncology
  • Sharett Institute - Hadassah Hebrew University Medical Center
  • Rabin MC; Davidof Center - Oncology Institute
  • Ella Institute - Sheba Medical Center
  • IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
  • IFO - Istituto Regina Elena; Oncologia Medica
  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • Istituto Tumori ?Giovanni Paolo II?, Oncologia
  • A.O.U. Senese Policlinico Santa Maria Alle Scotte
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
  • Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
  • Wellington Hospital; Wellington Blood and Cancer Centre
  • Mid Central DHB
  • Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
  • Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej
  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
  • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
  • Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
  • IPO de Lisboa; Servico de Oncologia Medica
  • IPO do Porto; Servico de Oncologia Medica
  • Moscow City Oncology Hospital #62
  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
  • St. Petersburg Oncology Hospital
  • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Hospital Universitari Vall d'Hebron; Oncology
  • Hospital Clínic i Provincial; Servicio de Oncología
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Universitario Virgen de la Macarena;
  • Fundacion Instituto Valenciano de Oncologia (IVO)
  • Hospital General Universitario de Valencia; Servicio de oncologia
  • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Bristol Haematology and Oncology centre
  • Beatson West of Scotland Cancer Centre
  • Ipswich Hospital; Oncology Pharmacy
  • St James Uni Hospital; Icrf Cancer Medicine Research Unit
  • Guys and St Thomas NHS Foundation Trust, Guys Hospital
  • Freeman Hospital; Northern Centre For Cancer Care
  • Singleton Hospital; Pharmacy Department
  • Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo

Atezolizumab Placebo + Cobimetinib + Vemurafenib

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first

Secondary Outcome Measures

Progression-Free Survival (PFS), as Determined by Independent Review Committee Using RECIST v1.1
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by an IRC according to RECIST v1.1, or death from any cause, whichever occurs first
Percentage of Participants With Objective Response, as Determined by Investigator Using RECIST v1.1
Objective response is defined as a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1
Duration of Response, as Determined by Investigator Using RECIST v1.1
DOR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
Overall Survival
OS is defined as the time from randomization to death from any cause
Percentage of Participants Who Have Survived at 2 Years
2-year landmark survival, defined as survival at 2 years
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 to deterioration in global health status/healthrelated quality of life (GHS/HRQoL), defined as the time from randomization to first observed ≥ 10-point decrease in EORTC QLQ-C30 linearly transformed GHS/HRQoL scale score that is sustained for two consecutive assessments or followed by death while the participant is on treatment. The score range for each EORTC QLQ-C30 scale is from 0 to 100, with higher scores indicating better functioning and better GHS/HRQoL.
Time to Deterioration in Physical Functioning Using EORTC QLQ-C30 Physical Functioning Scale Score
Time to deterioration in physical functioning, defined as the time from randomization to first observed ≥ 10-point decrease in EORTC QLQ-C30 linearly transformed physical functioning scale score that is sustained for two consecutive assessments or followed by death while the participant is on treatment. The score range for each EORTC QLQ-C30 scale is from 0 to 100, with higher scores indicating better functioning and better GHS/HRQoL.
Percentage of Participants With Adverse Events and Serious Adverse Events
Serum Concentration of Atezolizumab
Plasma Concentration of Cobimetinib Dose: 20/40 mg
Plasma Concentration of Cobimetinib Dose: 60 mg
Plasma Concentration of Vemurafenib
Percentage of Participants Positive for Anti-Drug Antibodies (ADA) to Atezolizumab
Presence of ADAs against atezolizumab during the study relative to the presence of ADAs at baseline

Full Information

First Posted
September 19, 2016
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT02908672
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 13, 2017 (Actual)
Primary Completion Date
October 11, 2019 (Actual)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
514 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Atezolizumab Placebo + Cobimetinib + Vemurafenib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Will be administered as per the schedule described in individual arm.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab Placebo
Intervention Description
Will be administered as per the schedule described in individual arm.
Intervention Type
Drug
Intervention Name(s)
Cobimetinib
Intervention Description
Will be administered as per the schedule described in individual arm.
Intervention Type
Drug
Intervention Name(s)
Vemurafenib
Intervention Description
Will be administered as per the schedule described in individual arm.
Intervention Type
Drug
Intervention Name(s)
Vemurafenib Placebo
Intervention Description
Will be administered as per the schedule described in individual arm.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 33 months)
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS), as Determined by Independent Review Committee Using RECIST v1.1
Description
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by an IRC according to RECIST v1.1, or death from any cause, whichever occurs first
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 33 months)
Title
Percentage of Participants With Objective Response, as Determined by Investigator Using RECIST v1.1
Description
Objective response is defined as a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 33 months)
Title
Duration of Response, as Determined by Investigator Using RECIST v1.1
Description
DOR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 33 months)
Title
Overall Survival
Description
OS is defined as the time from randomization to death from any cause
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 33 months)
Title
Percentage of Participants Who Have Survived at 2 Years
Description
2-year landmark survival, defined as survival at 2 years
Time Frame
2 years
Title
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
Description
Time to deterioration in global health status/healthrelated quality of life (GHS/HRQoL), defined as the time from randomization to first observed ≥ 10-point decrease in EORTC QLQ-C30 linearly transformed GHS/HRQoL scale score that is sustained for two consecutive assessments or followed by death while the participant is on treatment. The score range for each EORTC QLQ-C30 scale is from 0 to 100, with higher scores indicating better functioning and better GHS/HRQoL.
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 33 months)
Title
Time to Deterioration in Physical Functioning Using EORTC QLQ-C30 Physical Functioning Scale Score
Description
Time to deterioration in physical functioning, defined as the time from randomization to first observed ≥ 10-point decrease in EORTC QLQ-C30 linearly transformed physical functioning scale score that is sustained for two consecutive assessments or followed by death while the participant is on treatment. The score range for each EORTC QLQ-C30 scale is from 0 to 100, with higher scores indicating better functioning and better GHS/HRQoL.
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 33 months)
Title
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 33 months)
Title
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 33 months)(1 Cycle = 28 days)
Title
Plasma Concentration of Cobimetinib Dose: 20/40 mg
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)
Title
Plasma Concentration of Cobimetinib Dose: 60 mg
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)
Title
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)
Title
Percentage of Participants Positive for Anti-Drug Antibodies (ADA) to Atezolizumab
Description
Presence of ADAs against atezolizumab during the study relative to the presence of ADAs at baseline
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 33 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 (</=)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
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
Arizona Oncology Associates, PC - HAL
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
UF Health Cancer Center at Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32824
Country
United States
Facility Name
Oncology Specialists, S.C.
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
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
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Peter Maccallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Medical University of Graz, Department of Dermatology
City
Graz
ZIP/Postal Code
8030
Country
Austria
Facility Name
LKH Innsbruck; Universitätsklinik für Dermatologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Dermatologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Sint Augustinus Wilrijk
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Clinicas Oncologicas Integradas - COI
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
22290-160
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88020-210
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Beneficencia Portuguesa de Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01321-00
Country
Brazil
Facility Name
Tom Baker Cancer Centre-Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Juravinski Cancer Clinic; Department of Oncology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
LHSC - Victoria Hospital; London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Lakeridge Health Oshawa; Oncology
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre; Oncology
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1K9
Country
Canada
Facility Name
CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Groupe Hospitalier Saint André - Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital du Bocage; Dermatologie
City
Dijon
ZIP/Postal Code
21079
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 Saint Eloi; CHU de Montpellier; Svc de Dermatologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nantes; Cancéro-dermatologie
City
Nantes
ZIP/Postal Code
44093
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
CHU de Rouen - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Institut Gustave Roussy; Dermatologie
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Charite - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Elbekliniken Buxtehude; Klinik für Dermatologie
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitätsklinikum Erlangen; Hautklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Essen; Klinik für Dermatologie
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum d.Universität zu Köln Klinik u.Poliklinik f.Dermatologie
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Leipzig; Klinik für Dermatologie, Venerologie und Allergologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Fachklinik Hornheide; Dermatologie
City
Münster
ZIP/Postal Code
48157
Country
Germany
Facility Name
Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Würzburg; Med. Klinik 1, Pneumologie
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Laiko General Hospital Athen
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Metropolitan Hospital; Dept. of Oncology
City
Pireaus
ZIP/Postal Code
185 47
Country
Greece
Facility Name
Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Rambam Health Care Campus; Oncology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Sharett Institute - Hadassah Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin MC; Davidof Center - Oncology Institute
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Ella Institute - Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
IFO - Istituto Regina Elena; Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
Istituto Tumori ?Giovanni Paolo II?, Oncologia
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
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
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
City
Rotterdam
ZIP/Postal Code
3015AA
Country
Netherlands
Facility Name
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Wellington Hospital; Wellington Blood and Cancer Centre
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Mid Central DHB
City
Palmerston North
ZIP/Postal Code
4442
Country
New Zealand
Facility Name
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej
City
Kraków
ZIP/Postal Code
31-115
Country
Poland
Facility Name
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Pozna?
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
City
Wroc?aw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
IPO de Lisboa; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
City
Saint-Petersburg
State/Province
Sankt Petersburg
Country
Russian Federation
Facility Name
St. Petersburg Oncology Hospital
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Clinica Universitaria de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena;
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Fundacion Instituto Valenciano de Oncologia (IVO)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital General Universitario de Valencia; Servicio de oncologia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Bristol Haematology and Oncology centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Ipswich Hospital; Oncology Pharmacy
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
St James Uni Hospital; Icrf Cancer Medicine Research Unit
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust, Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Freeman Hospital; Northern Centre For Cancer Care
City
New Castle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Singleton Hospital; Pharmacy Department
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35131452
Citation
Robert C, Lewis KD, Gutzmer R, Stroyakovskiy D, Gogas H, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Caro I, Forbes H, Shah K, Yan Y, Li H, McArthur GA, Ascierto PA. Biomarkers of treatment benefit with atezolizumab plus vemurafenib plus cobimetinib in BRAFV600 mutation-positive melanoma. Ann Oncol. 2022 May;33(5):544-555. doi: 10.1016/j.annonc.2022.01.076. Epub 2022 Feb 4.
Results Reference
derived
PubMed Identifier
33476492
Citation
de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAFV600 wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.
Results Reference
derived
PubMed Identifier
32534646
Citation
Gutzmer R, Stroyakovskiy D, Gogas H, Robert C, Lewis K, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Manikhas GM, Yan Y, Huang KC, Uyei A, McNally V, McArthur GA, Ascierto PA. Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAFV600 mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Jun 13;395(10240):1835-1844. doi: 10.1016/S0140-6736(20)30934-X. Erratum In: Lancet. 2020 Aug 15;396(10249):466.
Results Reference
derived

Learn more about this 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

We'll reach out to this number within 24 hrs