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AzTrials

Advanced BRAFV600 Wild-type MelanomaPhase 3NCT03273153

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

A Phase 3 study testing Cobimetinib, Atezolizumab and Pembrolizumab in people with Advanced BRAFV600 Wild-type Melanoma, run by Hoffmann-La Roche at 121 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced BRAFV600 Wild-type Melanoma
What is being tested?
Cobimetinib, Atezolizumab and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
446 participants
Where
121 sitesin 15 countries
Study dates
11 Dec 2017to 19 Feb 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 32Show fewer
  • 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

Trial locations and contacts

121 sites in 15 countries.

121 sites in 15 countries

United States23 sites

  • University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)

    Ann Arbor, Michigan, 48109

  • St. Luke's University Health network

    Bethlehem, Pennsylvania, 18015

  • Massachusetts General Hospital;Hematology/ Oncology

    Boston, Massachusetts, 02114

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • Northwestern University

    Chicago, Illinois, 60611

  • TriHealth Hatton Institute; Surgical Education

    Cincinnati, Ohio, 45220

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • M.D Anderson Cancer Center; Uni of Texas At Houston

    Houston, Texas, 77030

  • Dartmouth-Hitchcock Medical Center; Hematology/Oncology

    Lebanon, New Hampshire, 03756

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • West Virginia University Hospitals Inc

    Morgantown, West Virginia, 26056

  • Morristown Medical Center

    Morristown, New Jersey, 07962

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • USC Norris Cancer Center; USC Oncology Hematology Newport Beach

    Newport Beach, California, 92663

  • University of California at Irvine Medical Center; Department of Oncology

    Orange, California, 92868

  • UF Health Cancer Center at Orlando Health

    Orlando, Florida, 32824

  • Thomas Jefferson University Hospital;Medical Oncology

    Philadelphia, Pennsylvania, 19107

  • Florida Cancer Specialist, North Region

    St. Petersburg, Florida, 33705

  • Stanford Comprehensive Cancer Center

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

Other trials in United States

France16 sites

  • Hopital Avicenne; Dermatologie

    Bobigny, 93009

  • Hopital Saint Andre CHU De Bordeaux; Dermatologie

    Bordeaux, 33075

  • Chu Site Du Bocage;Dermatologie

    Dijon, 21079

  • CHU de Grenoble - Hôpital Nord

    Grenoble, 38043

  • Centre Hospitalier Le Mans; Dermatologie

    Le Mans, 72037

  • Hopital Claude Huriez; Sce Dermatologie

    Lille, 59037

  • Hopital Timone Adultes; Dermatologie

    Marseille, 13385

  • CHU de Nantes; Cancéro-dermatologie

    Nantes, 44093

  • Hopital l Archet 2; Ginestriere, Service de; Dermatologie

    Nice, 06200

  • Groupe Hospitalier Bichat Claude Bernard

    Paris, 75018

  • Hopital Saint Louis; Dermatologie 1

    Paris, 75475

  • Hopital Robert Debre; DERMATOLOGIE

    Reims, 51092

  • Centre Eugene Marquis; Service d'oncologie

    Rennes, 35042

  • Hopital Charles Nicolle; Dermatologie Serv.

    Rouen, 76031

  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

    Toulouse, 31059

  • Institut Gustave Roussy; Dermatologie

    Villejuif, 94805

Other trials in France

Spain15 sites

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Clínic i Provincial; Servicio de Oncología

    Barcelona, 08036

  • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

    Las Palmas de Gran Canaria, LAS Palmas, 35016

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Universitario Son Espases; Servicio de Oncologia

    Palma de Mallorca, Balearic Islands, 07014

  • Clinica Universitaria de Navarra; Servicio de oncología

    Pamplona, Navarre, 31008

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen Macarena; Servicio de Oncologia

    Seville, 41009

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, 46014

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

Germany13 sites

  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie

    Dresden, 01307

  • HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

    Erfurt, 99089

  • Universitatsklinikum Essen; Klinik für Dermatologie

    Essen, 45147

  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

    Frankfurt, 60590

  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

    Gera, 07548

  • Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

    Hanover, 30625

  • UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

    Kiel, 24105

  • Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie

    Mainz, 55131

  • Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

    Mannheim, 68167

  • Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

    Minden, 32429

  • Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie

    München, 80337

  • Fachklinik Hornheide; Dermatologie

    Münster, 48157

  • Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen

    Tübingen, 72076

Other trials in Germany

Italy11 sites

  • A.O.U. Cons. Policlinico Bari - Consorzlale Policlinico; Scienze Biomediche e Oncologia Umana

    Bari, Apulia, 70124

  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

    Candiolo, Piedmont, 10060

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

    Genoa, Liguria, 16132

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

    Milan, Lombardy, 20133

  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

    Milan, Lombardy, 20141

  • A.O. Universitaria Policlinico Di Modena; Ematologia

    Modena, Emilia-Romagna, 41124

  • Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

    Naples, Campania, 80131

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

    Naples, Campania, 80131

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

  • Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

    Pisa, Tuscany, 56126

  • IFO - Istituto Regina Elena; Oncologia Medica

    Rome, Lazio, 00144

Other trials in Italy

United Kingdom8 sites

  • BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

    Bristol, BS2 8HW

  • Western General Hospital; Edinburgh Cancer Center

    Edinburgh, EH4 2XU

  • Leicester Royal Infirmary; Dept. of Medical Oncology

    Leicester, LE1 5WW

  • University College London Hospital

    London, NW1 - 2PG

  • Guys & St Thomas Hospital; Department of Oncology

    London, SE1 9RT

  • University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

  • Singleton Hospital; Pharmacy

    Swansea, SA2 8QA

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

Other trials in United Kingdom

Poland6 sites

  • Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

    Gdansk, 80-219

  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

    Lublin, 20-090

  • Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

    Poznan, 60-780

  • Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

    Szczecin, 71-730

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, 02-781

  • Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw, 53-413

Other trials in Poland

Australia5 sites

  • Cairns Base Hospital

    Cairns, Queensland, 4870

  • Townsville General Hospital

    Douglas, Queensland, 4184

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Greece4 sites

  • Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

    Athens, 115 22

  • Laiko General Hospital Athen

    Athens, 115 27

  • Metropolitan Hospital; Dept. of Oncology

    Pireaus, 185 47

  • Bioclinic Thessaloniki

    Thessaloniki, 546 22

Other trials in Greece

Netherlands4 sites

  • Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

    Amsterdam, 1066 CX

  • Amphia Ziekenhuis, locatie Langendijk;Oncology

    Breda, 4818 CK

  • Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

    Rotterdam, 3015AA

  • Zuyderland ziekenhuis locatie Geleen

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Russia4 sites

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

    Moscow, 115478

  • St. Petersburg Oncology Hospital

    Saint Petersburg, 198255

  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

    Saint Petersburg

Other trials in Russia

South Korea4 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Belgium3 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Hungary3 sites

  • Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

    Budapest, 1122

  • Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

    Pécs, 7632

  • University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology

    Szeged, 6720

Other trials in Hungary

Brazil2 sites

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

Other trials in Brazil

About this study

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

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.

Being tested
Cobimetinib, Atezolizumab, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CobimetinibDrug

    Cobimetinib 60 mg tablets orally once daily on a 21 days on, 7 days off schedule.

  • AtezolizumabDrug

    Atezolizumab 840 mg as IV infusion once in every 2 weeks.

  • PembrolizumabDrug

    Pembrolizumab 200 mg as IV infusion once in every 3 weeks.

Study groups in NCT03273153
Study groupRoleWhat they receive
Cobimetinib and AtezolizumabExperimentalParticipants 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.
Receives: Drug: Cobimetinib; Drug: Atezolizumab
PembrolizumabActive comparatorParticipants 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.
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

Secondary outcomes (15)

  1. 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.

    Measured: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

  2. 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).

    Measured: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

  3. 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

    Measured: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

  4. 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.

    Measured: Week 16

  5. Overall Survival (OS)

    OS is defined as the time from randomization to death from any cause.

    Measured: From randomization up to approximately 3 years

  6. 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.

    Measured: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

  7. 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.

    Measured: Up to 3 years

  8. 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.'

    Measured: At 2 years

  9. 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.

    Measured: 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.

  10. 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.

    Measured: Up to approximately 16 months

  11. Number of Participants With Abnormal Vital Signs

    Vital signs will include temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure.

    Measured: From baseline up to approximately 3 years

  12. Number of Participants With Laboratory Abnormalities

    Participants with laboratory abnormalities (values outside of a defined range) will be reported.

    Measured: Up to approximately 16 months

  13. Plasma Concentration of Cobimetinib

    Measured: Days 1 and 15 of Cycle 1

  14. Serum Concentration of Atezolizumab

    Measured: Day 1 of Cycles 1, 2, and 3

  15. 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.

    Measured: Day 1 of Cycle 1, 2, 3 and 30 days after treatment discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2017
  2. Study start11 Dec 2017
  3. Primary completion15 Apr 2019
  4. Study completion19 Feb 2021

Why it stopped: This study was terminated due to benefit/risk analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03273153
Sponsor's protocol ID
CO39722
Other IDs
2016-004387-18, 2016
Status last verified
Aug 2022
First submitted
1 Sep 2017
Last updated
21 Sep 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 33476492

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cobimetinib, Atezolizumab and Pembrolizumab in people with Advanced BRAFV600 Wild-type Melanoma, run by Hoffmann-La Roche at 121 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, France, Spain, Germany, Italy and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) as Determined by the Independent Review Committee (IRC) (time frame: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03273153, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

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