Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02108652
First received: April 7, 2014
Last updated: November 3, 2016
Last verified: November 2016
Results First Received: July 1, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bladder Cancer
Intervention: Drug: Atezolizumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The analysis included data up to cutoff date 14 September 2015.

Reporting Groups
  Description
Cohort 2: Participants With Second-line or Beyond Treatments Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.

Participant Flow:   Overall Study
    Cohort 2: Participants With Second-line or Beyond Treatments
STARTED   310 
COMPLETED   0 
NOT COMPLETED   310 
Death                193 
Unspecified                1 
Withdrawal by Subject                8 
Ongoing at data cutoff 14 September 2015                108 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Cohort 2 Safety Evaluable Population included all participants who received any amount of study drug.

Reporting Groups
  Description
Cohort 2: Participants With Second-line or Beyond Treatments Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.

Baseline Measures
   Cohort 2: Participants With Second-line or Beyond Treatments 
Overall Participants Analyzed 
[Units: Participants]
 310 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.6  (10.1) 
Gender 
[Units: Participants]
Count of Participants
 
Female      69  22.3% 
Male      241  77.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

2.  Primary:   Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

3.  Secondary:   Duration of Response as Assessed by the IRF According to RECIST v1.1   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

4.  Secondary:   Duration of Response as Assessed by the Investigator According to RECIST v1.1   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

5.  Secondary:   Duration of Response as Assessed by the Investigator According to Modified RECIST   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

6.  Secondary:   Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

7.  Secondary:   Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

8.  Secondary:   Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

9.  Secondary:   PFS as Assessed by the Investigator According to RECIST v1.1   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

10.  Secondary:   Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

11.  Secondary:   PFS as Assessed by the Investigator According to Modified RECIST   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

12.  Secondary:   Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1   [ Time Frame: Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

13.  Secondary:   Percentage of Participants Who Died   [ Time Frame: Baseline until death (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

14.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline until death (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]

15.  Secondary:   Percentage of Participants Alive at 1-year   [ Time Frame: 1-year ]

16.  Secondary:   Maximum Serum Concentration (Cmax) of Atezolizumab   [ Time Frame: Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days) ]

17.  Secondary:   Minimum Serum Concentration (Cmin) of Atezolizumab   [ Time Frame: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days) ]

18.  Secondary:   Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab   [ Time Frame: Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02108652     History of Changes
Other Study ID Numbers: GO29293 (Cohort 2)
IMvigor 210 ( Other Identifier: Genentech Inc. )
2013-005486-39 ( EudraCT Number )
Study First Received: April 7, 2014
Results First Received: July 1, 2016
Last Updated: November 3, 2016
Health Authority: United States: Food and Drug Administration