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Trial record 1 of 1 for:    MO29518
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A Study of Atezolizumab in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02458638
Recruitment Status : Active, not recruiting
First Posted : June 1, 2015
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.

Condition or disease Intervention/treatment Phase
Tumors Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicohort, Phase II Study of Atezolizumab in Advanced Solid Tumors
Actual Study Start Date : July 13, 2015
Actual Primary Completion Date : April 4, 2018
Estimated Study Completion Date : December 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atezolizumab
The dose of atezolizumab in this study will be 1200 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Atezolizumab will be given as IV infusion over 60 minutes on Day 1 of Cycle 1, then over 30 minutes (as tolerated) on Day 1 of each subsequent 3-week cycle.
Other Name: Tecentriq




Primary Outcome Measures :
  1. NPR: Percentage of Participants with CR, PR, or SD at 18 Weeks [ Time Frame: At 18 weeks ]
    Assessment will be performed using RECIST v1.1 (in all participants except participants with prostate cancer and malignant pleural mesothelioma) or Prostate Response Evaluation Criteria (in participants with prostate cancer) or Malignant Pleural Mesothelioma Response Evaluation Criteria (in participants with malignant pleural mesothelioma).


Secondary Outcome Measures :
  1. NPR: Percentage of Participants with CR, PR, or SD at 24 Weeks [ Time Frame: At 24 weeks ]
    Assessment will be performed using RECIST v1.1 (in all participants except participants with prostate cancer and malignant pleural mesothelioma) or Prostate Response Evaluation Criteria (in participants with prostate cancer) or Malignant Pleural Mesothelioma Response Evaluation Criteria (in participants with malignant pleural mesothelioma).

  2. Overall Response Rate (ORR): Percentage of Participants with CR or PR [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
    Assessment will be performed using RECIST v1.1 (in all participants except participants with prostate cancer and malignant pleural mesothelioma) or Prostate Response Evaluation Criteria (in participants with prostate cancer) or Malignant Pleural Mesothelioma Response Evaluation Criteria (in participants with malignant pleural mesothelioma).

  3. Percentage of Participants by Best Overall Response (BOR) [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
    Assessment will be performed using RECIST v1.1 (in all participants except participants with prostate cancer and malignant pleural mesothelioma) or Prostate Response Evaluation Criteria (in participants with prostate cancer) or Malignant Pleural Mesothelioma Response Evaluation Criteria (in participants with malignant pleural mesothelioma).

  4. Clinical Benefit Rate (CBR): Percentage of Participants with CR, PR, or SD Lasting for >/=6 Weeks [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
    Assessment will be performed using RECIST v1.1 (in all participants except participants with prostate cancer and malignant pleural mesothelioma) or Prostate Response Evaluation Criteria (in participants with prostate cancer) or Malignant Pleural Mesothelioma Response Evaluation Criteria (in participants with malignant pleural mesothelioma).

  5. Duration of Objective Response (DOR) [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
    Assessment will be performed using RECIST v1.1 (in all participants except participants with prostate cancer and malignant pleural mesothelioma) or Prostate Response Evaluation Criteria (in participants with prostate cancer) or Malignant Pleural Mesothelioma Response Evaluation Criteria (in participants with malignant pleural mesothelioma).

  6. Progression-Free Survival (PFS) [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
    Assessment will be performed using RECIST v1.1 (in all participants except participants with prostate cancer and malignant pleural mesothelioma) or Prostate Response Evaluation Criteria (in participants with prostate cancer) or Malignant Pleural Mesothelioma Response Evaluation Criteria (in participants with malignant pleural mesothelioma).

  7. Time to Progression (TTP) [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
    Assessment will be performed using RECIST v1.1 (in all participants except participants with prostate cancer and malignant pleural mesothelioma) or Prostate Response Evaluation Criteria (in participants with prostate cancer) or Malignant Pleural Mesothelioma Response Evaluation Criteria (in participants with malignant pleural mesothelioma).

  8. Overall Survival (OS) [ Time Frame: Baseline until death due to any cause (up to 24 months) ]
  9. Percentage of Participants with Adverse Events [ Time Frame: Baseline up to 24 months ]
  10. Mean Number of Cycles of Atezolizumab [ Time Frame: Baseline up to 24 months ]
  11. Mean Dose of Atezolizumab [ Time Frame: Baseline up to 24 months ]
  12. Percentage of Participants with Anti-Atezolizumab Antibodies [ Time Frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation (up to 24 months); and within 30 and 120 days after last dose (up to 24 months overall) ]
  13. Maximum Plasma Concentration Observed (Cmax) of Atezolizumab [ Time Frame: At 30 minutes after the end of infusion (infusion = 60 minutes) on Day 1 of Cycle 1 (cycle length = 21 days) ]
  14. Minimum Plasma Concentration Observed (Cmin) of Atezolizumab [ Time Frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation (up to 24 months); and at study end (up to 24 months overall) ]
  15. NPR: Percentage of Participants with CR, PR, or SD According to Modified RECIST Criteria [ Time Frame: At 18 and 24 weeks ]
  16. ORR: Percentage of Participants with CR or PR According to Modified RECIST Criteria [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
  17. Percentage of Participants by BOR According to Modified RECIST Criteria [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
  18. CBR: Percentage of Participants with CR, PR, or SD Lasting for >/=6 Weeks According to Modified RECIST Criteria [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
  19. DOR According to Modified RECIST Criteria [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
  20. PFS According to Modified RECIST Criteria [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]
  21. TTP According to Modified RECIST Criteria [ Time Frame: Baseline up to 24 months (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) ]


Information from the National Library of Medicine

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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:

  • Histologically documented advanced solid tumors that meet protocol-defined cohort specifications, have progressive disease at study entry, and have received at least one line of prior systemic therapy or for which no alternative therapy to prolong survival exists
  • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or in freshly cut and unstained slides (exceptional cases) with an associated pathology report for central testing
  • Measurable disease as defined by RECIST v1.1 or disease-specific criteria for prostate cancer and malignant pleural mesothelioma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Negative serum pregnancy test result within 14 days prior to study drug among women of childbearing potential
  • Life expectancy > 3 months

Exclusion Criteria:

  • Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1 except those with a negligible risk of metastasis or death
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures >/=1 time per month
  • History of asymptomatic or symptomatic central nervous system (CNS) metastasis
  • Leptomeningeal disease
  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >/=2 weeks prior to Day 1 of Cycle 1
  • Pregnant and lactating women
  • Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1
  • Severe infection within 4 weeks prior to Day 1 of Cycle 1
  • Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
  • History of autoimmune disease except treated/stable hypothyroidism, Type 1 diabetes mellitus, and protocol-specified dermatologic conditions
  • Active tuberculosis
  • Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1
  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, or anti-programmed cell death-1 (PD-1) or anti-PD-L1 therapeutic antibodies
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1, or anticipated requirement for systemic immunosuppressive medications during the trial

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): NCT02458638


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Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Memorial Sloan Kettering
New York, New York, United States, 10065
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Tennessee
Sarah Cannon Cancer Center and Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Austria
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz, Austria, 8036
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei
Wien, Austria, 1090
Brazil
INCA 1- Instituto Nacional de Câncer
Rio de Janeiro, RJ, Brazil, 20231-050
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-003
FUNFARME
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Denmark
Aarhus Universitetshospital; Kræftafdelingen
Aarhus N, Denmark, 8200
Herlev Hospital; Onkologisk afdeling
Herlev, Denmark, 2730
Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
Odense C, Denmark, 5000
Finland
Helsinki University Central Hospital; Dept of Oncology
Helsinki, Finland, 00029
France
Institut Bergonie
Bordeaux, France, 33076
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France, 69373
Hopital Saint Louis, Service D Oncologie Medicale
Paris, France, 75475
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik
Hamburg, Germany, 20246
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
Heidelberg, Germany, 69120
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier, Germany, 54290
Ireland
St Vincent'S Uni Hospital; Medical Oncology
Dublin, Ireland, 4
St James' Hospital; Cancer Clinical Trials Office
Dublin, Ireland
Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, Italy, 80131
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Lombardia, Italy, 20133
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena, Toscana, Italy, 53100
Netherlands
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Norway
Haukeland Universitetssjukehus; Klinisk forskningspost
Bergen, Norway, 5021
Oslo Universitetssykehus HF; Radiumhospitalet
Oslo, Norway, 0310
Poland
Centrum Onkologii w Bydgoszczy
Bydgoszcz, Poland, 85-796
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk, Poland, 80-214
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, Poland, 20-090
Centrum Onkologii - Instytut, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warszawa, Poland, 02-781
Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow, Russian Federation, 115478
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint-Petersburg, Russian Federation, 197758
Saint-Petersburg City Clinical Oncology Dispensary
St Petersburg, Russian Federation, 197022
Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra, Spain, 31008
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Switzerland
Freiburger Spital; Onkologie
Fribourg, Switzerland, 1708
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen, Switzerland, 9007
Turkey
Trakya University Medical Faculty
Edirne, Turkey, 22030
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, Turkey, 34300
Okmeydani T and R Hospital; Med Onc
Istanbul, Turkey, 34384
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, Ankara, Turkey, 06100
United Kingdom
Clatterbridge Cancer Centre
Bebington, United Kingdom, CH63 4JY
Southampton General Hospital; Medical Oncology
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02458638     History of Changes
Other Study ID Numbers: MO29518
2015-000269-30 ( EudraCT Number )
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Atezolizumab
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents