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A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

Primary Purpose

Advanced BRAFV600 Wild-type Melanoma

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

About this trial

This is an interventional treatment trial for Advanced BRAFV600 Wild-type Melanoma

Eligibility Criteria

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

Inclusion Criteria:

Disease-Specific Inclusion Criteria

  • Histologically confirmed locally advanced and unresectable or metastatic melanoma
  • Naive to prior systemic anti-cancer therapy for melanoma
  • Documentation of BRAFV600 wild-type status in melanoma tumor tissue through use of a clinical mutation test approved by the local health authority
  • A representative, formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 20 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report prior to study entry. If 20 slides are not available or the tissue block is not of sufficient size, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Age >=18 years at time of signing Informed Consent Form
  • Ability to comply with the study protocol, in the investigator's judgment
  • Histologically or cytologically confirmed BRAFV600 wild-type melanoma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy >=3 months
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent or use at least two forms of effective contraceptive with a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of cobimetinib and at least 5 months after the last dose of atezolizumab or pembrolizumab
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures (e.g. condom), and agreement to refrain from donating sperm, for at least 3 months after the last dose of cobimetinib
  • Willingness and ability of patients to report selected study outcomes (e.g., GHS and HRQoL) using an electronic device or paper backup questionnaires.

Exclusion Criteria:

General Exclusion Criteria

  • Inability to swallow medications
  • Malabsorption condition that would alter the absorption of orally administered medications
  • Pregnancy, breastfeeding, or intention of becoming pregnant during the study
  • History of severe hypersensitivity reactions to components of the cobimetinib, atezolizumab, or pembrolizumab formulations
  • Current or recent treatment with therapeutic antibiotics, live attenuated vaccines or systemic immunostimulatory/immunosuppresive medication
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study Cancer-Related Exclusion Criteria
  • Ocular melanoma
  • Major surgery or radiotherapy within 21 days prior to Day 1 of Cycle 1 or anticipation of needing such procedure while receiving study treatment
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
  • Active or untreated central nervous system (CNS) metastases Exclusions Related to Cardiovascular Disease
  • Unstable angina, new-onset angina within last 3 months, myocardial infarction within the last 6 months prior to Day 1 of Cycle 1, or current congestive heart failure classified as New York Heart Association Class II or higher
  • Left ventricular ejection fraction (LVEF) below institutional lower limit of normal or <50%, whichever is lower
  • Poorly controlled hypertension, defined as sustained, uncontrolled, non-episodic baseline hypertension consistently above 159/99 mmHg despite optimal medical management
  • History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third degree heart block, or evidence of prior myocardial infarction Exclusions Related to Infections
  • HIV infection
  • Active tuberculosis infection
  • Severe infections within 4 weeks prior to Day 1 of Cycle 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Signs or symptoms of clinically relevant infection within 2 weeks prior to Day 1 of Cycle 1
  • Treatment with oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
  • Active or chronic viral hepatitis B or C infection Exclusions Related to Ocular Disease
  • Known risk factors for ocular toxicity Exclusions Related to Autoimmune Conditions and Immunomodulatory Drugs
  • Active or history of autoimmune disease or immune deficiency
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1, Cycle 1 Exclusions Related to Other Medical Conditions or Medications
  • Active malignancy (other than melanoma) or a prior malignancy within the past 3 years
  • Any Grade >=3 hemorrhage or bleeding event within 28 days of Day 1 of Cycle 1
  • History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1
  • Proteinuria >3.5 gm/24 hr
  • Consumption of foods, supplements, or drugs that are strong or moderate CYP3A4 enzyme inducers or inhibitors at least 7 days prior to Day 1 of Cycle 1 and during study treatment

Sites / Locations

  • University of Arizona Cancer Center
  • City of Hope Comprehensive Cancer Center
  • USC Norris Cancer Center
  • USC Norris Cancer Center; USC Oncology Hematology Newport Beach
  • University of California at Irvine Medical Center; Department of Oncology
  • Stanford Comprehensive Cancer Center
  • UF Health Cancer Center at Orlando Health
  • Florida Cancer Specialist, North Region
  • Moffitt Cancer Center
  • Florida Cancer Specialists
  • Northwestern University
  • Massachusetts General Hospital;Hematology/ Oncology
  • University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)
  • Dartmouth-Hitchcock Medical Center; Hematology/Oncology
  • Morristown Medical Center
  • Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists
  • TriHealth Hatton Institute; Surgical Education
  • St. Luke's University Health network
  • Thomas Jefferson University Hospital;Medical Oncology
  • SCRI Tennessee Oncology Chattanooga
  • Sarah Cannon Research Institute
  • M.D Anderson Cancer Center; Uni of Texas At Houston
  • West Virginia University Hospitals Inc
  • Cairns Base Hospital
  • Townsville General Hospital
  • Princess Alexandra Hospital
  • Royal Hobart Hospital
  • Fiona Stanley Hospital
  • Cliniques Universitaires St-Luc
  • AZ Groeninge
  • UZ Leuven Gasthuisberg
  • Instituto Nacional de Cancer - INCa; Oncologia
  • Hospital das Clinicas - UFRGS
  • Hopital Avicenne; Dermatologie
  • Hopital Saint Andre CHU De Bordeaux; Dermatologie
  • Chu Site Du Bocage;Dermatologie
  • CHU de Grenoble - Hôpital Nord
  • Centre Hospitalier Le Mans; Dermatologie
  • Hopital Claude Huriez; Sce Dermatologie
  • Hopital Timone Adultes; Dermatologie
  • CHU de Nantes; Cancéro-dermatologie
  • Hopital l Archet 2; Ginestriere, Service de; Dermatologie
  • Groupe Hospitalier Bichat Claude Bernard
  • Hopital Saint Louis; Dermatologie 1
  • Hopital Robert Debre; DERMATOLOGIE
  • Centre Eugene Marquis; Service d'oncologie
  • Hopital Charles Nicolle; Dermatologie Serv.
  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
  • Institut Gustave Roussy; Dermatologie
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie
  • HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie
  • Universitatsklinikum Essen; Klinik für Dermatologie
  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
  • Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
  • UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
  • Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie
  • Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
  • Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
  • Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie
  • Fachklinik Hornheide; Dermatologie
  • Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen
  • Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
  • Laiko General Hospital Athen
  • Metropolitan Hospital; Dept. of Oncology
  • Bioclinic Thessaloniki
  • Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly
  • Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika
  • University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology
  • Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica
  • IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
  • A.O. Universitaria Policlinico Di Modena; Ematologia
  • 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
  • A.O.U. Cons. Policlinico Bari - Consorzlale Policlinico; Scienze Biomediche e Oncologia Umana
  • Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico
  • IOV - Istituto Oncologico Veneto IRCCS
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
  • Amphia Ziekenhuis, locatie Langendijk;Oncology
  • Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
  • Zuyderland ziekenhuis locatie Geleen
  • Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
  • Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.
  • Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
  • Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
  • 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
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Hospital Universitario Son Espases; Servicio de Oncologia
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
  • Clinica Universitaria de Navarra; Servicio de oncología
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Clínic i Provincial; Servicio de Oncología
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Instituto Valenciano Oncologia; Oncologia Medica
  • Hospital General Universitario de Valencia; Servicio de oncologia
  • Hospital Universitario Miguel Servet; Servicio Oncologia
  • BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department
  • Western General Hospital; Edinburgh Cancer Center
  • Leicester Royal Infirmary; Dept. of Medical Oncology
  • University College London Hospital
  • Guys & St Thomas Hospital; Department of Oncology
  • University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
  • Singleton Hospital; Pharmacy
  • Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cobimetinib and Atezolizumab

Pembrolizumab

Arm Description

Participants will receive 60 mg of cobimetinib orally from Days 1 to 21 along with 840 mg of atezolizumab by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first. There will be no cobimetinib administration for 7 days (Days 22-28) in each cycle.

Participants will receive 200 mg of pembrolizumab administered by IV infusion every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) as Determined by the Independent Review Committee (IRC)
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. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.

Secondary Outcome Measures

PFS as Determined by the Investigator
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. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.
Objective Response as Determined by the Investigator
Objective response rate is defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions >/=4 weeks apart, as determined by the investigator through the use of RECIST v1.1. For target lesion, CR: the disappearance of all target lesions, any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. For non-target lesion, CR: the disappearance of all non-target lesions and (if applicable) normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis).
Objective Response as Determined by IRC
Objective response, defined as a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by IRC according to RECIST v1.1
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with a complete response, a partial response, or stable disease at 16 weeks. For target lesion, CR: the disappearance of all target lesions, any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. For non-target lesion, CR: the disappearance of all non-target lesions and (if applicable) normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). Stable disease (SD): neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Duration of Objective Response Determined by the IRC
Duration of objective response, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by an IRC according to RECIST v1.1, or death from any cause, whichever occurs first.
Duration of Objective Response Determined by the Investigator
Duration of objective response is defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator through use of RECIST v1.1, or death from any cause, whichever occurs first.
Two-year Landmark Survival
Two-year landmark survival is defined as the rate of survival at 2 years. Two-year landmark survival is defined as the rate of survival at 2 years and was calculated using Kaplan-Meier analysis, which is commonly used to estimate the probability of an event at time 't.'
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
HRQoL scores are assessed through global health status (GHS)/ quality of life (QoL) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30). These are based on questions 29 and 30 of the EORTC QLQ-C30. These questions on global health status/QoL scale are coded on 7-point scale (1=very poor to 7=excellent). Raw scores will be linearly transformed to obtain the score ranging from 0 to 100, where higher score represents a higher ("better") level of functioning.
Number of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Number of Participants With Abnormal Vital Signs
Vital signs will include temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure.
Number of Participants With Laboratory Abnormalities
Participants with laboratory abnormalities (values outside of a defined range) will be reported.
Plasma Concentration of Cobimetinib
Serum Concentration of Atezolizumab
Percentage of Participants With Anti-drug Antibodies (ADAs)
Participants with ADAs during the study relative to the prevalence of ADAs at baseline will be reported.

Full Information

First Posted
September 1, 2017
Last Updated
August 24, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03273153
Brief Title
A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma
Official Title
A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated due to benefit/risk analysis.
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
February 19, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced BRAFV600 Wild-type Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cobimetinib and Atezolizumab
Arm Type
Experimental
Arm Description
Participants will receive 60 mg of cobimetinib orally from Days 1 to 21 along with 840 mg of atezolizumab by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first. There will be no cobimetinib administration for 7 days (Days 22-28) in each cycle.
Arm Title
Pembrolizumab
Arm Type
Active Comparator
Arm Description
Participants will receive 200 mg of pembrolizumab administered by IV infusion every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Cobimetinib
Intervention Description
Cobimetinib 60 mg tablets orally once daily on a 21 days on, 7 days off schedule.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab 840 mg as IV infusion once in every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab 200 mg as IV infusion once in every 3 weeks.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) as Determined by the Independent Review Committee (IRC)
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. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.
Time Frame
Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months
Secondary Outcome Measure Information:
Title
PFS as Determined by the Investigator
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. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.
Time Frame
Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months
Title
Objective Response as Determined by the Investigator
Description
Objective response rate is defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions >/=4 weeks apart, as determined by the investigator through the use of RECIST v1.1. For target lesion, CR: the disappearance of all target lesions, any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. For non-target lesion, CR: the disappearance of all non-target lesions and (if applicable) normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis).
Time Frame
Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months
Title
Objective Response as Determined by IRC
Description
Objective response, defined as a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by IRC according to RECIST v1.1
Time Frame
Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months
Title
Disease Control Rate (DCR)
Description
DCR is defined as the proportion of participants with a complete response, a partial response, or stable disease at 16 weeks. For target lesion, CR: the disappearance of all target lesions, any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. For non-target lesion, CR: the disappearance of all non-target lesions and (if applicable) normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). Stable disease (SD): neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
Time Frame
Week 16
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
From randomization up to approximately 3 years
Title
Duration of Objective Response Determined by the IRC
Description
Duration of objective response, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by an IRC according to RECIST v1.1, or death from any cause, whichever occurs first.
Time Frame
Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months
Title
Duration of Objective Response Determined by the Investigator
Description
Duration of objective response is defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator through use of RECIST v1.1, or death from any cause, whichever occurs first.
Time Frame
Up to 3 years
Title
Two-year Landmark Survival
Description
Two-year landmark survival is defined as the rate of survival at 2 years. Two-year landmark survival is defined as the rate of survival at 2 years and was calculated using Kaplan-Meier analysis, which is commonly used to estimate the probability of an event at time 't.'
Time Frame
At 2 years
Title
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
Description
HRQoL scores are assessed through global health status (GHS)/ quality of life (QoL) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30). These are based on questions 29 and 30 of the EORTC QLQ-C30. These questions on global health status/QoL scale are coded on 7-point scale (1=very poor to 7=excellent). Raw scores will be linearly transformed to obtain the score ranging from 0 to 100, where higher score represents a higher ("better") level of functioning.
Time Frame
Up to approximately 16 months. Follow up is reported at weeks after participant treatment discontinuation, which could occur at any time during the study. Total time frame does not exceed 16 months.
Title
Number of Participants With Adverse Events (AEs)
Description
An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
Up to approximately 16 months
Title
Number of Participants With Abnormal Vital Signs
Description
Vital signs will include temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure.
Time Frame
From baseline up to approximately 3 years
Title
Number of Participants With Laboratory Abnormalities
Description
Participants with laboratory abnormalities (values outside of a defined range) will be reported.
Time Frame
Up to approximately 16 months
Title
Plasma Concentration of Cobimetinib
Time Frame
Days 1 and 15 of Cycle 1
Title
Serum Concentration of Atezolizumab
Time Frame
Day 1 of Cycles 1, 2, and 3
Title
Percentage of Participants With Anti-drug Antibodies (ADAs)
Description
Participants with ADAs during the study relative to the prevalence of ADAs at baseline will be reported.
Time Frame
Day 1 of Cycle 1, 2, 3 and 30 days after treatment discontinuation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Disease-Specific Inclusion Criteria Histologically confirmed locally advanced and unresectable or metastatic melanoma Naive to prior systemic anti-cancer therapy for melanoma Documentation of BRAFV600 wild-type status in melanoma tumor tissue through use of a clinical mutation test approved by the local health authority A representative, formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 20 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report prior to study entry. If 20 slides are not available or the tissue block is not of sufficient size, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Age >=18 years at time of signing Informed Consent Form Ability to comply with the study protocol, in the investigator's judgment Histologically or cytologically confirmed BRAFV600 wild-type melanoma Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Life expectancy >=3 months Adequate hematologic and end-organ function For women of childbearing potential: agreement to remain abstinent or use at least two forms of effective contraceptive with a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of cobimetinib and at least 5 months after the last dose of atezolizumab or pembrolizumab For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures (e.g. condom), and agreement to refrain from donating sperm, for at least 3 months after the last dose of cobimetinib Willingness and ability of patients to report selected study outcomes (e.g., GHS and HRQoL) using an electronic device or paper backup questionnaires. Exclusion Criteria: General Exclusion Criteria Inability to swallow medications Malabsorption condition that would alter the absorption of orally administered medications Pregnancy, breastfeeding, or intention of becoming pregnant during the study History of severe hypersensitivity reactions to components of the cobimetinib, atezolizumab, or pembrolizumab formulations Current or recent treatment with therapeutic antibiotics, live attenuated vaccines or systemic immunostimulatory/immunosuppresive medication Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study Cancer-Related Exclusion Criteria Ocular melanoma Major surgery or radiotherapy within 21 days prior to Day 1 of Cycle 1 or anticipation of needing such procedure while receiving study treatment Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days Active or untreated central nervous system (CNS) metastases Exclusions Related to Cardiovascular Disease Unstable angina, new-onset angina within last 3 months, myocardial infarction within the last 6 months prior to Day 1 of Cycle 1, or current congestive heart failure classified as New York Heart Association Class II or higher Left ventricular ejection fraction (LVEF) below institutional lower limit of normal or <50%, whichever is lower Poorly controlled hypertension, defined as sustained, uncontrolled, non-episodic baseline hypertension consistently above 159/99 mmHg despite optimal medical management History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third degree heart block, or evidence of prior myocardial infarction Exclusions Related to Infections HIV infection Active tuberculosis infection Severe infections within 4 weeks prior to Day 1 of Cycle 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Signs or symptoms of clinically relevant infection within 2 weeks prior to Day 1 of Cycle 1 Treatment with oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1 Active or chronic viral hepatitis B or C infection Exclusions Related to Ocular Disease Known risk factors for ocular toxicity Exclusions Related to Autoimmune Conditions and Immunomodulatory Drugs Active or history of autoimmune disease or immune deficiency Prior allogeneic stem cell or solid organ transplantation History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1, Cycle 1 Exclusions Related to Other Medical Conditions or Medications Active malignancy (other than melanoma) or a prior malignancy within the past 3 years Any Grade >=3 hemorrhage or bleeding event within 28 days of Day 1 of Cycle 1 History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1 Proteinuria >3.5 gm/24 hr Consumption of foods, supplements, or drugs that are strong or moderate CYP3A4 enzyme inducers or inhibitors at least 7 days prior to Day 1 of Cycle 1 and during study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
USC Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Norris Cancer Center; USC Oncology Hematology Newport Beach
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
University of California at Irvine Medical Center; Department of Oncology
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford Comprehensive Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
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
Florida Cancer Specialist, North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Massachusetts General Hospital;Hematology/ Oncology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center; Hematology/Oncology
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
TriHealth Hatton Institute; Surgical Education
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
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;Medical Oncology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
M.D Anderson Cancer Center; Uni of Texas At Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
West Virginia University Hospitals Inc
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26056
Country
United States
Facility Name
Cairns Base Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Townsville General Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4184
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Instituto Nacional de Cancer - INCa; Oncologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hopital Avicenne; Dermatologie
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital Saint Andre CHU De Bordeaux; Dermatologie
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Chu Site Du Bocage;Dermatologie
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de Grenoble - Hôpital Nord
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier Le Mans; Dermatologie
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Hopital Claude Huriez; Sce Dermatologie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Timone Adultes; Dermatologie
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU de Nantes; Cancéro-dermatologie
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital l Archet 2; Ginestriere, Service de; Dermatologie
City
Nice cedex 3
ZIP/Postal Code
06200
Country
France
Facility Name
Groupe Hospitalier Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Saint Louis; Dermatologie 1
City
Paris
ZIP/Postal Code
75475
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
Hopital Charles Nicolle; Dermatologie Serv.
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy; Dermatologie
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitatsklinikum Essen; Klinik für Dermatologie
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
City
Minden
ZIP/Postal Code
32429
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
Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
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
Bioclinic Thessaloniki
City
Thessaloniki
ZIP/Postal Code
546 22
Country
Greece
Facility Name
Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika
City
Pecs
ZIP/Postal Code
7632
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
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Universitaria Policlinico Di Modena; Ematologia
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
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
A.O.U. Cons. Policlinico Bari - Consorzlale Policlinico; Scienze Biomediche e Oncologia Umana
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto IRCCS
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
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
Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Amphia Ziekenhuis, locatie Langendijk;Oncology
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
City
Rotterdam
ZIP/Postal Code
3015AA
Country
Netherlands
Facility Name
Zuyderland ziekenhuis locatie Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.
City
Poznań
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
City
Szczecin
ZIP/Postal Code
71-730
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
City
Wrocław
ZIP/Postal Code
53-413
Country
Poland
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
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
City
Saint-Petersburg
Country
Russian Federation
Facility Name
St. Petersburg Oncology Hospital
City
St Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Son Espases; Servicio de Oncologia
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35016
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de oncología
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
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 General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
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 ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Western General Hospital; Edinburgh Cancer Center
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Leicester Royal Infirmary; Dept. of Medical Oncology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 - 2PG
Country
United Kingdom
Facility Name
Guys & St Thomas Hospital; Department of Oncology
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
City
Stoke-On-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Singleton Hospital; Pharmacy
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
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

Learn more about this trial

A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

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