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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03273153
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Advanced BRAFV600 Wild-type Melanoma Drug: Cobimetinib Drug: Atezolizumab Drug: Pembrolizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : September 17, 2024
Estimated Study Completion Date : September 17, 2024


Arm Intervention/treatment
Experimental: Cobimetinib and Atezolizumab
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.
Drug: Cobimetinib
Cobimetinib 60 mg tablets orally once daily on a 21 days on, 7 days off schedule.

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

Active Comparator: Pembrolizumab
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.
Drug: Pembrolizumab
Pembrolizumab 200 mg as IV infusion once in every 3 weeks.




Primary Outcome Measures :
  1. 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 80 wks and then every 12 wks thereafter ]

    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.

    Tumor assessments, including contrast-enhanced CT or MRI scans, will be performed every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through 80 wks and then every 12 wks thereafter, until confirmed disease progression or loss of clinical benefit, withdrawal of consent, study termination by the Sponsor or death, whichever occurs first.



Secondary Outcome Measures :
  1. PFS as Determined by the Investigator [ Time Frame: Up to 7 years ]
    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.

  2. Objective Response determined by the IRC [ Time Frame: Up to 7 years ]
    Objective response, defined as a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by an IRC according to RECIST v1.1

  3. Objective Response Rate determined by the Investigator [ Time Frame: Up to 7 years ]
    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).

  4. Disease Control Rate (DCR) [ Time Frame: Up to 7 years ]
    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.

  5. Overall Survival (OS) [ Time Frame: Up to 7 years ]
    OS is defined as the time from randomization to death from any cause.

  6. Duration of objective response determined by the IRC [ Time Frame: Up to 7 years ]
    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.

  7. Duration of Objective Response determined by the Investigator [ Time Frame: Up to 7 years ]
    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.

  8. Two-year Landmark Survival [ Time Frame: At 2 years ]
    Two-year landmark survival is defined as survival at 2 years.

  9. Change From Baseline in Health-related Quality of Life (HRQoL) Scores [ Time Frame: Up to 7 years ]
    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.

  10. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 7 years ]
    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.

  11. Number of Participants With Abnormal Vital Signs [ Time Frame: Up to 7 years ]
    Vital signs will include temperature pulse rate, respiratory rate, and systolic and diastolic blood pressure.

  12. Number of Participants With Laboratory Abnormalities [ Time Frame: Up to 7 years ]
    Participants with laboratory abnormalities will be reported.

  13. Plasma Concentration of Cobimetinib [ Time Frame: Days 1 and 15 of Cycle 1 ]
    Plasma concentration of cobimetinib at specified time points will be reported.

  14. Serum Concentration of Atezolizumab [ Time Frame: Day 1 of Cycle 1, 2, 3 and 30 days after treatment discontinuation ]
    Serum concentration of atezolizumab at specified time points will be reported.

  15. Percentage of Participants with Anti-drug Antibodies (ADAs) [ Time Frame: Day 1 of Cycle 1, 2, 3 and 30 days after treatment discontinuation ]
    Participants with ADAs during the study relative to the prevalence of ADAs at baseline will be reported.



Information from the National Library of Medicine

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273153


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: CO39722 www.roche.com/about_roche/roche_worldwide.htm +1 888-662-6728 global-roche-genentech-trials@gene.com

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Locations
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United States, Alabama
University of South Alabama; Mitchell Cancer Institute Terminated
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Oncology Associates, PC - HAL Terminated
Chandler, Arizona, United States, 85224
University of Arizona Cancer Center Active, not recruiting
Tucson, Arizona, United States, 85719
United States, Arkansas
Highlands Oncology Group Terminated
Rogers, Arkansas, United States, 72758
United States, California
City of Hope Comprehensive Cancer Center Active, not recruiting
Duarte, California, United States, 91010
City of Hope, Antelope Valley Active, not recruiting
Lancaster, California, United States, 93534
The Angeles Clinic and Research Institute - W LA Office Withdrawn
Los Angeles, California, United States, 90025
USC Norris Cancer Center Active, not recruiting
Los Angeles, California, United States, 90033
USC Norris Cancer Center; USC Oncology Hematology Newport Beach Active, not recruiting
Newport Beach, California, United States, 92663
University of California at Irvine Medical Center; Department of Oncology Active, not recruiting
Orange, California, United States, 92868
UC Davis Cancer Center; Oncology Terminated
Sacramento, California, United States, 95817
California Pacific Medical Center Research Institute Withdrawn
San Francisco, California, United States, 94115
St Mary's Medical Center Terminated
San Francisco, California, United States, 94121
Stanford Comprehensive Cancer Center Active, not recruiting
Stanford, California, United States, 94305
United States, Colorado
Rocky Mountain Cancer Center - Aurora Terminated
Aurora, Colorado, United States, 80012
Univ of Colorado Terminated
Aurora, Colorado, United States, 80045
United States, Florida
Memorial Healthcare System Office of Human Research Terminated
Hollywood, Florida, United States, 33021
Mount Sinai Medical Center Terminated
Miami Beach, Florida, United States, 33140
UF Health Cancer Center at Orlando Health Active, not recruiting
Orlando, Florida, United States, 32824
Memorial Cancer Institute at Memorial West Terminated
Pembroke Pines, Florida, United States, 33028
Florida Cancer Specialist, North Region Completed
Saint Petersburg, Florida, United States, 33705
SCRI Florida Cancer Specialists PAN Terminated
Tallahassee, Florida, United States, 32308
Moffitt Cancer Center Active, not recruiting
Tampa, Florida, United States, 33612
Florida Cancer Specialists Active, not recruiting
West Palm Beach, Florida, United States, 33401
United States, Illinois
Northwestern University Completed
Chicago, Illinois, United States, 60611
Oncology Specialists SC Terminated
Niles, Illinois, United States, 60714
United States, Indiana
Parkview Physicians Group Terminated
Fort Wayne, Indiana, United States, 46845
United States, Massachusetts
Massachusetts General Hospital;Hematology/ Oncology Active, not recruiting
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute; Dept Dana-Farber Cancer Inst Terminated
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan; Michigan Institute for Clinical and Health Research (MICHR) Active, not recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Minnesota Oncology Minneapolis Terminated
Minneapolis, Minnesota, United States, 55404
United States, New Hampshire
Dartmouth-Hitchcock Medical Center; Hematology/Oncology Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center Terminated
Hackensack, New Jersey, United States, 07601
Morristown Medical Center Active, not recruiting
Morristown, New Jersey, United States, 07962
United States, New York
Columbia University Medical Center Terminated
New York, New York, United States, 10032
United States, North Carolina
Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
TriHealth Hatton Institute; Surgical Education Active, not recruiting
Cincinnati, Ohio, United States, 45220
UC Health Clinical Trials Office; Division of Hematology-Oncology Terminated
Cincinnati, Ohio, United States, 45267
Fairview Hosp/Cleveland Clin Terminated
Cleveland, Ohio, United States, 44111
Cleveland Clinic Terminated
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center- Hillcrest Terminated
Mayfield Heights, Ohio, United States, 44124
Wooster Milltown Specialty and Surgery Center; Cleveland Clinic Satellite Site Terminated
Wooster, Ohio, United States, 44691
United States, Pennsylvania
St. Luke's University Health network Active, not recruiting
Bethlehem, Pennsylvania, United States, 18015
Thomas Jefferson University Hospital;Medical Oncology Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Hillman Cancer Center;Medical Oncology Terminated
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Rhode Island Hospital Terminated
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina Terminated
Charleston, South Carolina, United States, 29425
United States, Tennessee
SCRI Tennessee Oncology Chattanooga Completed
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Research Institute Active, not recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center; Vanderbilt University Withdrawn
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Onc-Central Austin CA Ct Terminated
Austin, Texas, United States, 78731
Baylor University Medical Center Terminated
Dallas, Texas, United States, 75226
Texas Oncology, P.A. - Fort Worth Terminated
Fort Worth, Texas, United States, 76104
M.D Anderson Cancer Center; Uni of Texas At Houston Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute at The University of Utah Withdrawn
Salt Lake City, Utah, United States, 84112
United States, West Virginia
West Virginia University Hospitals Inc Active, not recruiting
Morgantown, West Virginia, United States, 26056
Australia, Queensland
Cairns Base Hospital Active, not recruiting
Cairns, Queensland, Australia, 4870
Townsville General Hospital Active, not recruiting
Douglas, Queensland, Australia, 4184
Princess Alexandra Hospital Active, not recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, Tasmania
Royal Hobart Hospital Completed
Hobart, Tasmania, Australia, 7000
Australia, Western Australia
Fiona Stanley Hospital Completed
Murdoch, Western Australia, Australia, 6150
Belgium
Cliniques Universitaires St-Luc Recruiting
Bruxelles, Belgium, 1200
AZ Groeninge Active, not recruiting
Kortrijk, Belgium, 8500
UZ Leuven Gasthuisberg Active, not recruiting
Leuven, Belgium, 3000
Sint Augustinus Wilrijk Terminated
Wilrijk, Belgium, 2610
Brazil
Instituto Nacional de Cancer - INCa; Pesquisa Clinica Active, not recruiting
Rio De Janerio, RJ, Brazil, 20560-120
Hospital das Clinicas - UFRGS Recruiting
Porto Alegre, RS, Brazil, 90035-003
Centro de Pesquisas Oncologicas - CEPON Withdrawn
Florianopolis, SC, Brazil, 88034-000
Instituto do Cancer do Estado de Sao Paulo - ICESP Withdrawn
Sao Paulo, SP, Brazil, 01246-000
Canada, Ontario
London Regional Cancer Centre Withdrawn
London, Ontario, Canada, N6A 4L6
Lakeridge Health Oshawa; Oncology Withdrawn
Oshawa, Ontario, Canada, L1G 2B9
Sunnybrook Health Sciences Centre Withdrawn
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital, Medical Oncology & Haematology Withdrawn
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Chuq - Hopital Hotel Dieu de Quebec; Oncology Withdrawn
Quebec City, Quebec, Canada, G1R 2J6
France
Hopital Avicenne; Dermatologie Active, not recruiting
Bobigny, France, 93009
Hopital Saint Andre CHU De Bordeaux; Dermatologie Active, not recruiting
Bordeaux, France, 33075
Chu Site Du Bocage;Dermatologie Active, not recruiting
Dijon, France, 21079
CHU de Grenoble - Hôpital Nord Active, not recruiting
Grenoble, France, 38043
Centre Hospitalier Le Mans; Dermatologie Active, not recruiting
Le Mans, France, 72037
Hopital Claude Huriez; Sce Dermatologie Active, not recruiting
Lille, France, 59037
Hopital Timone Adultes; Dermatologie Active, not recruiting
Marseille, France, 13385
CHU de Nantes; Cancéro-dermatologie Active, not recruiting
Nantes, France, 44093
Hopital l Archet 2; Ginestriere, Service de; Dermatologie Active, not recruiting
Nice cedex 3, France, 06200
Groupe Hospitalier Bichat Claude Bernard Active, not recruiting
Paris, France, 75018
Hopital Saint Louis; Dermatologie 1 Active, not recruiting
Paris, France, 75475
Hopital Robert Debre; DERMATOLOGIE Active, not recruiting
Reims, France, 51092
Centre Eugene Marquis; Service d'oncologie Active, not recruiting
Rennes, France, 35042
Hopital Charles Nicolle; Dermatologie Serv. Active, not recruiting
Rouen, France, 76031
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) Active, not recruiting
Toulouse, France, 31059
Institut Gustave Roussy; Dermatologie Active, not recruiting
Villejuif, France, 94805
Germany
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie Active, not recruiting
Dresden, Germany, 01307
HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie Active, not recruiting
Erfurt, Germany, 99089
Universitatsklinikum Essen; Klinik für Dermatologie Active, not recruiting
Essen, Germany, 45147
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie Completed
Frankfurt, Germany, 60590
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie Active, not recruiting
Gera, Germany, 07548
Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie Active, not recruiting
Hannover, Germany, 30625
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie Active, not recruiting
Kiel, Germany, 24105
Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie Terminated
Magdeburg, Germany, 39120
Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz Recruiting
Mainz, Germany, 55131
Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie Active, not recruiting
Mannheim, Germany, 68167
Johannes Wesling Klinikum Minden Active, not recruiting
Minden, Germany, 32429
Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie Active, not recruiting
München, Germany, 80337
Fachklinik Hornheide; Dermatologie Active, not recruiting
Münster, Germany, 48157
Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen Active, not recruiting
Tübingen, Germany, 72076
Universitätsklinikum Ulm; Hauttumorzentrum Terminated
Ulm, Germany, 89081
Greece
Laiko General Hospital Athen Active, not recruiting
Athens, Greece, 115 27
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine Completed
Athens, Greece, 115220
Metropolitan Hospital; Dept. of Oncology Active, not recruiting
Pireaus, Greece, 185 47
Bioclinic Thessaloniki Active, not recruiting
Thessaloniki, Greece, 546 22
Hungary
Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly Active, not recruiting
Budapest, Hungary, 1122
Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika Active, not recruiting
Pecs, Hungary, 7632
University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology Active, not recruiting
Szeged, Hungary, 6720
Italy
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica Active, not recruiting
Napoli, Campania, Italy, 80131
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B Active, not recruiting
Napoli, Campania, Italy, 80131
A.O. Universitaria Policlinico Di Modena; Ematologia Active, not recruiting
Modena, Emilia-Romagna, Italy, 41100
IFO - Istituto Regina Elena; Oncologia Medica Active, not recruiting
Roma, Lazio, Italy, 00144
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A Active, not recruiting
Genova, Liguria, Italy, 16132
Asst Papa Giovanni XXIII; Oncologia Medica Terminated
Bergamo, Lombardia, Italy, 24128
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 Active, not recruiting
Milano, Lombardia, Italy, 20133
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica Active, not recruiting
Milano, Lombardia, Italy, 20141
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico Active, not recruiting
Candiolo, Piemonte, Italy, 10060
Policlinico Le Molinette; Clinica Dermatologica Withdrawn
Torino, Piemonte, Italy, 10126
A.O.U. Cons. Policlinico Bari - Consorzlale Policlinico; Scienze Biomediche e Oncologia Umana Active, not recruiting
Bari, Puglia, Italy, 70124
Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico Active, not recruiting
Pisa, Toscana, Italy, 56126
IOV - Istituto Oncologico Veneto IRCCS Active, not recruiting
Padova, Veneto, Italy, 35128
Korea, Republic of
Seoul National University Hospital Active, not recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center - Oncology Active, not recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Completed
Seoul, Korea, Republic of, 6351
Netherlands
Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde Active, not recruiting
Amsterdam, Netherlands, 1066 CX
Amphia Ziekenhuis, locatie Langendijk;Oncology Active, not recruiting
Breda, Netherlands, 4819 EV
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie Completed
Rotterdam, Netherlands, 3015AA
Zuyderland ziekenhuis locatie Geleen Completed
Sittard-Geleen, Netherlands, 6162 BG
Isala Withdrawn
Zwolle, Netherlands, 8025 AB
New Zealand
Auckland City Hospital Terminated
Auckland, New Zealand, 1023
Christchurch Hospital Terminated
Christchurch, New Zealand, 8011
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School Terminated
Tauranga, New Zealand, 3112
Poland
Wojewodzkie Centrum Onkologii Active, not recruiting
Gdansk, Poland, 80-219
Centrum Onkologii w Gliwicach; II Klinika Radioterapii i Chemioterapii Terminated
Gliwice, Poland, 44-101
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej Active, not recruiting
Lublin, Poland, 20-090
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu. Active, not recruiting
Poznań, Poland, 60-355
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych Active, not recruiting
Szczecin, Poland, 71-730
Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie Active, not recruiting
Warszawa, Poland, 02-781
Dolnoslaskie Centrum Onkologii Active, not recruiting
Wrocław, Poland, 53-413
Russian Federation
Moscow City Oncology Hospital #62 Recruiting
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" Recruiting
Moscow, Russian Federation, 115478
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" Recruiting
Saint-Petersburg, Russian Federation
St. Petersburg Oncology Hospital Active, not recruiting
St Petersburg, Russian Federation, 198255
Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia Withdrawn
Oviedo, Asturias, Spain, 33011
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Active, not recruiting
Badalona, Barcelona, Spain, 08916
Hospital Universitario Son Espases; Servicio de Oncologia Active, not recruiting
Palma De Mallorca, Islas Baleares, Spain, 07014
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Active, not recruiting
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia Active, not recruiting
Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
Clinica Universitaria de Navarra; Servicio de oncología Active, not recruiting
Pamplona, Navarra, Spain, 31008
Hospital Univ Vall d'Hebron; Servicio de Oncologia Recruiting
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Oncología Active, not recruiting
Barcelona, Spain, 08036
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Active, not recruiting
Madrid, Spain, 28007
Hospital Ramon y Cajal; Servicio de Oncologia Active, not recruiting
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre; Servicio de Oncologia Active, not recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia Active, not recruiting
Madrid, Spain, 28046
Hospital Universitario Virgen Macarena; Servicio de Oncologia Active, not recruiting
Sevilla, Spain, 41009
Hospital General Universitario de Valencia; Servicio de oncologia Recruiting
Valencia, Spain, 41014
Instituto Valenciano Oncologia; Oncologia Medica Active, not recruiting
Valencia, Spain, 46009
Hospital Universitario Miguel Servet; Servicio Oncologia Active, not recruiting
Zaragoza, Spain, 50009
United Kingdom
BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department Active, not recruiting
Bristol, United Kingdom, BS2 8HW
Ninewells Hosital; Clinical Research Centre Terminated
Dundee, United Kingdom, DD1 9SY
Western General Hospital; Edinburgh Cancer Center Active, not recruiting
Edinburgh, United Kingdom, EH4 2XU
Leicester Royal Infirmary; Dept. of Medical Oncology Active, not recruiting
Leicester, United Kingdom, LE1 5WW
University College London Hospital Active, not recruiting
London, United Kingdom, NW1 - 2PG
Guys & St Thomas Hospital; Department of Oncology Active, not recruiting
London, United Kingdom, SE1 9RT
The Royal Marsden NHS Foundation Trust; Oncology Terminated
London, United Kingdom, SW3 6JJ
The Christie NHS Foundation Trust Terminated
Manchester, United Kingdom, M20 4BX
University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital Active, not recruiting
Stoke-On-Trent, United Kingdom, ST4 6QG
Singleton Hospital; Pharmacy Active, not recruiting
Swansea, United Kingdom, SA2 8QA
Royal Cornwall Hospital Active, not recruiting
Truro, United Kingdom, TR1 3LQ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03273153     History of Changes
Other Study ID Numbers: CO39722
2016-004387-18 ( EudraCT Number )
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs