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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

Tracking Information
First Submitted Date  ICMJE May 28, 2015
First Posted Date  ICMJE June 1, 2015
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE July 13, 2015
Actual Primary Completion Date April 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
Non-Progression Rate (NPR) [ Time Frame: At 18 weeks ]
Change History Complete list of historical versions of study NCT02458638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
  • Non-Progression Rate (NPR) [ Time Frame: At 24 weeks ]
  • Overall Response Rate (ORR) [ Time Frame: Within 5 years ]
  • Best Overall Response (BOR) [ Time Frame: Within 5 years ]
  • Clinical Benefit Rate (CBR) [ Time Frame: Within 5 years ]
  • Duration of Objective Response (DOR) [ Time Frame: Within 5 years ]
  • Progression-Free Survival (PFS) [ Time Frame: Within 5 years ]
  • Time to Progression (TTP) [ Time Frame: Within 5 years ]
  • Overall Survival (OS) [ Time Frame: Within 5 years ]
  • Number of Participants with Adverse Events [ Time Frame: Within 5 years ]
  • Number of Cycles and Dose Intensity of Each Component of the Treatment Regimen [ Time Frame: Within 5 years ]
  • Percentage of participants with anti-MPDL3280A antibodies\n [ Time Frame: Within 5 years ]
  • Maximum Plasma Concentration Observed (Cmax) [ Time Frame: After infusion on Day 1 of Cycle 1 ]
  • Minimum Plasma Concentration Observed (Cmin) [ Time Frame: Prior to infusion on Day 1 of Cycles 1, 2, 3, 4, 8 and every eight cycles thereafter and at study termination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Atezolizumab in Advanced Solid Tumors
Official Title  ICMJE An Open-Label, Multicohort, Phase II Study of Atezolizumab in Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tumors
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
477
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2015)
250
Estimated Study Completion Date  ICMJE December 13, 2019
Actual Primary Completion Date April 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Brazil,   Canada,   Denmark,   Finland,   France,   Germany,   Ireland,   Italy,   Netherlands,   Norway,   Poland,   Russian Federation,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02458638
Other Study ID Numbers  ICMJE MO29518
2015-000269-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP