This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    MO29518
Previous Study | Return to List | Next Study

A Study of Atezolizumab in Advanced Solid Tumors

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02458638
First received: May 28, 2015
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
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 version 1.1 (RECIST v1.1), or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.

Condition Intervention Phase
Solid Tumor Drug: Atezolizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label, Multicohort, Phase II Study of Atezolizumab in Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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:
  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • Overall Survival (OS) [ Time Frame: Baseline until death due to any cause (up to 24 months) ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline up to 24 months ]
  • Mean Number of Cycles of Atezolizumab [ Time Frame: Baseline up to 24 months ]
  • Mean Dose of Atezolizumab [ Time Frame: Baseline up to 24 months ]
  • Percentage of Participants with Anti-Atezolizumab Antibodies [ Time Frame: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, and 8; then every 8 cycles up to treatment discontinuation (30 days after last dose) (up to 24 months), up to 120 days after last dose (up to 24 months) (cycle length = 21 days) ]
  • Maximum Plasma Concentration Observed (Cmax) of Atezolizumab [ Time Frame: At 30 minutes after the end of infusion on Day 1 of Cycle 1 (Cycle length = 21 days) (infusion duration = 60 minutes) ]
  • Minimum Plasma Concentration Observed (Cmin) of Atezolizumab [ Time Frame: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, and 8; then every 8 cycles up to treatment discontinuation (30 days after last dose) (up to 24 months), 120 days after last dose (up to 24 months) (cycle length = 21 days) ]
  • Percentage of Participants with CR, PR, or SD According to Modified RECIST Criteria at 18 and 24 Weeks [ Time Frame: At 18 and 24 weeks ]
  • Overall Response Rate (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) ]
  • Percentage of Participants by Best Overall Response (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) ]
  • Clinical Benefit Rate (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) ]
  • Duration of Objective Response (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) ]
  • Progression-Free Survival (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) ]
  • Time to Progression (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) ]

Estimated Enrollment: 725
Actual Study Start Date: July 13, 2015
Estimated Study Completion Date: November 29, 2020
Estimated Primary Completion Date: November 29, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

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

Inclusion Criteria:

  • Histologically documented advanced solid tumors that meet protocol defined cohort specifications that have progressed following 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 child-bearing 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 or Type 1 diabetes mellitus
  • 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, anti-programmed cell death 1 (PD-1), or anti-programmed cell death ligand 1 (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
  • Weight loss >5 percent within 4 weeks prior to Day 1
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02458638

Contacts
Contact: Reference Study ID Number: MO29518 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Hide Study Locations
Locations
United States, California
Stanford Univ Hosp & Clin Withdrawn
Stanford, California, United States, 94305
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Memorial Sloan Kettering Recruiting
New York, New York, United States, 10065
United States, Ohio
The Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
United States, Tennessee
Sarah Cannon Cancer Center and Research Institute Completed
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Austria
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie Recruiting
Graz, Austria, 8036
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei Recruiting
Wien, Austria, 1090
Brazil
INCA 1- Instituto Nacional de Câncer Active, not recruiting
Rio de Janeiro, RJ, Brazil, 20231-050
Hospital das Clinicas - UFRGS Recruiting
Porto Alegre, RS, Brazil, 90035-003
FUNFARME Terminated
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Instituto do Cancer do Estado de Sao Paulo - ICESP Recruiting
Sao Paulo, SP, Brazil, 01246-000
Canada, British Columbia
BCCA-Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
University Health Network; Princess Margaret Hospital; Medical Oncology Dept Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Denmark
Aarhus Universitetshospital; Kræftafdelingen Active, not recruiting
Aarhus C, Denmark, 8000
Herlev Hospital; Onkologisk afdeling Recruiting
Herlev, Denmark, 2730
Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forksnings Enhed Recruiting
Odense C, Denmark, 5000
Finland
Helsinki University Central Hospital; Dept of Oncology Recruiting
Helsinki, Finland, 00029
France
Institut Bergonie Active, not recruiting
Bordeaux, France, 33076
Centre Leon Berard; Departement Oncologie Medicale Active, not recruiting
Lyon, France, 69373
Hopital Saint Louis, Service D Oncologie Medicale Active, not recruiting
Paris, France, 75475
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Germany
Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik Recruiting
Hamburg, Germany, 20246
Universitatsklinik Heidelberg; Universitatshautklinik und Nationales Centrum fur Tumorerkrankungen Recruiting
Heidelberg, Germany, 69120
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie Recruiting
Trier, Germany, 54290
Ireland
St Vincent'S Uni Hospital; Medical Oncology Recruiting
Dublin, Ireland, 4
St James' Hospital; Cancer Clinical Trials Office Recruiting
Dublin, Ireland
Italy
Istituto Nazionale Tumori Fondazione G. Pascale Active, not recruiting
Napoli, Campania, Italy, 80131
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Lombardia, Italy, 20133
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica Active, not recruiting
Siena, Toscana, Italy, 53100
Netherlands
Antoni van Leeuwenhoek Ziekenhuis Recruiting
Amsterdam, Netherlands, 1066 CX
Erasmus MC Recruiting
Rotterdam, Netherlands, 3000 CA
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Norway
Haukeland Universitetssjukehus; Klinisk forskningspost Active, not recruiting
Bergen, Norway, 5021
Oslo Universitetssykehus HF; Radiumhospitalet Active, not recruiting
Oslo, Norway, 0310
Poland
Centrum Onkologii w Bydgoszczy Recruiting
Bydgoszcz, Poland, 85-796
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii Recruiting
Gdansk, Poland, 80-952
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej Recruiting
Lublin, Poland, 20-090
Centrum Onkologii - Instytut, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow Recruiting
Warszawa, Poland, 02-781
Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy Recruiting
Moscow, Russian Federation, 115478
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) Recruiting
Saint-Petersburg, Russian Federation, 197758
Saint-Petersburg City Clinical Oncology Dispensary Terminated
St Petersburg, Russian Federation, 197022
Spain
Clinica Universitaria de Navarra; Servicio de Oncologia Recruiting
Pamplona, Navarra, Spain, 31008
Hospital Univ Vall d'Hebron; Servicio de Oncologia Recruiting
Barcelona, Spain, 08035
Switzerland
Freiburger Spital; Onkologie Recruiting
Fribourg, Switzerland, 1708
Kantonsspital St. Gallen; Onkologie/Hämatologie Active, not recruiting
St. Gallen, Switzerland, 9007
Turkey
Trakya University Medical Faculty Active, not recruiting
Edirne, Turkey, 22030
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology Active, not recruiting
Istanbul, Turkey, 34300
Okmeydani T and R Hospital; Med Onc Recruiting
Istanbul, Turkey, 34384
Ege Uni Medical Faculty Hospital; Oncology Dept Withdrawn
Izmir, Turkey, 35100
Hacettepe Uni Medical Faculty Hospital; Oncology Dept Active, not recruiting
Sıhhiye, ANKARA, Turkey, 06100
United Kingdom
Clatterbridge Cancer Centre Recruiting
Bebington, United Kingdom, CH63 4JY
Southampton General Hospital; Medical Oncology Recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02458638     History of Changes
Other Study ID Numbers: MO29518
2015-000269-30 ( EudraCT Number )
Study First Received: May 28, 2015
Last Updated: June 16, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on June 23, 2017