A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen (IMbassador250)
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| ClinicalTrials.gov Identifier: NCT03016312 |
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Recruitment Status :
Completed
First Posted : January 10, 2017
Results First Posted : April 30, 2021
Last Update Posted : February 17, 2023
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Prostatic Neoplasms, Castration-Resistant |
| Interventions |
Drug: Atezolizumab Drug: Enzalutamide |
| Enrollment | 772 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Atezolizumab + Enzalutamide | Enzalutamide |
|---|---|---|
 Arm/Group Description |
Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months). | Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months). |
| Period Title: Overall Study | ||
| Started | 391 | 380 |
| Completed | 150 | 162 |
| Not Completed | 241 | 218 |
| Reason Not Completed | ||
| Death | 194 | 164 |
| Lost to Follow-up | 11 | 12 |
| Started new therapy, loss of contact | 2 | 1 |
| Physician Decision | 0 | 2 |
| Withdrawal by Subject | 34 | 39 |
Baseline Characteristics
| Arm/Group Title | Atezolizumab + Enzalutamide | Enzalutamide | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months). | Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months). | Total of all reporting groups | |
| Overall Number of Baseline Participants | 391 | 380 | 771 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 391 participants | 380 participants | 771 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
101 25.8%
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90 23.7%
|
191 24.8%
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| >=65 years |
290 74.2%
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290 76.3%
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580 75.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 391 participants | 380 participants | 771 participants | |
| 70.3 (8.3) | 70.6 (8.5) | 70.4 (8.4) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 391 participants | 380 participants | 771 participants | |
| Female |
0 0.0%
|
0 0.0%
|
0 0.0%
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|
| Male |
391 100.0%
|
380 100.0%
|
771 100.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 391 participants | 380 participants | 771 participants | |
| Hispanic or Latino |
18 4.6%
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11 2.9%
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29 3.8%
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| Not Hispanic or Latino |
349 89.3%
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345 90.8%
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694 90.0%
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| Unknown or Not Reported |
24 6.1%
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24 6.3%
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48 6.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 391 participants | 380 participants | 771 participants | |
| American Indian or Alaska Native |
0 0.0%
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1 0.3%
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1 0.1%
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| Asian |
71 18.2%
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65 17.1%
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136 17.6%
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| Native Hawaiian or Other Pacific Islander |
1 0.3%
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0 0.0%
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1 0.1%
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| Black or African American |
8 2.0%
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7 1.8%
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15 1.9%
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| White |
290 74.2%
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287 75.5%
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577 74.8%
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| More than one race |
2 0.5%
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0 0.0%
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2 0.3%
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| Unknown or Not Reported |
19 4.9%
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20 5.3%
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39 5.1%
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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: | NCT03016312 |
| Other Study ID Numbers: |
CO39385 2016-003092-22 ( EudraCT Number ) |
| First Submitted: | January 9, 2017 |
| First Posted: | January 10, 2017 |
| Results First Submitted: | April 5, 2021 |
| Results First Posted: | April 30, 2021 |
| Last Update Posted: | February 17, 2023 |