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A Study of Atezolizumab in Advanced Solid Tumors

This study is currently recruiting participants.
See Contacts and Locations
Verified July 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: July 19, 2017
Last verified: July 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 (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.

Condition Intervention Phase
Tumors Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody 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: 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) ]
  • 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) ]
  • 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) ]
  • NPR: Percentage of Participants with CR, PR, or SD According to Modified RECIST Criteria [ Time Frame: At 18 and 24 weeks ]
  • 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 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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: February 12, 2021
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 (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

  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, 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
  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

  Show 53 Study Locations
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: July 19, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on July 26, 2017