A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection (IMvigor010)
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| ClinicalTrials.gov Identifier: NCT02450331 |
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Recruitment Status :
Terminated
(Sponsor decided to terminate the study early because the study did not meet its primary endpoint and because the study had met its goals of providing safety and additional exploratory efficacy information for atezolizumab monotherapy in MIBC.)
First Posted : May 21, 2015
Results First Posted : November 18, 2020
Last Update Posted : June 18, 2023
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Carcinoma, Transitional Cell |
| Intervention |
Drug: Atezolizumab |
| Enrollment | 809 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Observation | Atezolizumab |
|---|---|---|
 Arm/Group Description |
Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year). | Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year). |
| Period Title: Overall Study | ||
| Started | 403 | 406 |
| Completed | 171 | 178 |
| Not Completed | 232 | 228 |
| Reason Not Completed | ||
| Death | 162 | 171 |
| Lost to Follow-up | 14 | 12 |
| Withdrawal by Subject | 55 | 44 |
| Non-specified other | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Observation | Atezolizumab | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year). | Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year). | Total of all reporting groups | |
| Overall Number of Baseline Participants | 403 | 406 | 809 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 403 participants | 406 participants | 809 participants | |
| 65.9 (9.3) | 66.0 (9.0) | 65.9 (9.1) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 403 participants | 406 participants | 809 participants | |
| Female |
87 21.6%
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84 20.7%
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171 21.1%
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| Male |
316 78.4%
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322 79.3%
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638 78.9%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 403 participants | 406 participants | 809 participants | |
| Hispanic or Latino |
9 2.2%
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16 3.9%
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25 3.1%
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| Not Hispanic or Latino |
357 88.6%
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369 90.9%
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726 89.7%
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| Unknown or Not Reported |
37 9.2%
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21 5.2%
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58 7.2%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Number of Participants |
Number Analyzed | 403 participants | 406 participants | 809 participants |
| American Indian or Alaska Native | 0 | 1 | 1 | |
| Asian | 68 | 64 | 132 | |
| Black or African American | 3 | 3 | 6 | |
| White | 307 | 320 | 627 | |
| Other | 4 | 6 | 10 | |
| Unknown | 21 | 12 | 33 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title: | Medical Communications |
| Organization: | Hoffmann-La Roche |
| Phone: | 800-821-8590 |
| EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT02450331 |
| Other Study ID Numbers: |
WO29636 2014-005603-25 ( EudraCT Number ) |
| First Submitted: | May 19, 2015 |
| First Posted: | May 21, 2015 |
| Results First Submitted: | October 21, 2020 |
| Results First Posted: | November 18, 2020 |
| Last Update Posted: | June 18, 2023 |