A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave150)
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ClinicalTrials.gov Identifier: NCT03434379 |
Recruitment Status :
Completed
First Posted : February 15, 2018
Results First Posted : November 5, 2021
Last Update Posted : October 23, 2023
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Carcinoma, Hepatocellular |
Interventions |
Drug: Atezolizumab Drug: Bevacizumab Drug: Sorafenib |
Enrollment | 558 |
Participant Flow
Recruitment Details | Participants were enrolled at 117 sites in 17 countries: Australia, Canada, China, Czech Republic, Germany, Spain, France, United Kingdom, Hong Kong, Italy, Japan, Republic of Korea, Poland, Russian Federation, Singapore, Taiwan, United States. |
Pre-assignment Details | The total study population included 558 participants. The Global population included 501 participants. An additional 57 participants enrolled during the China Extension. The total China population included 137 Chinese participants from the Global population plus 57 participants from the China extension. 137 participants were part of the Global as well as China populations. Separate analyses were performed for the Global population and the China population in the study. |
Arm/Group Title | Sorafenib - Global | Atezolizumab + Bevacizumab - Global | Sorafenib - China | Atezolizumab + Bevacizumab - China |
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Arm/Group Description | Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
Period Title: Global Period | ||||
Started | 165 | 336 | 0 | 0 |
Completed | 0 | 0 | 0 | 0 |
Not Completed | 165 | 336 | 0 | 0 |
Reason Not Completed | ||||
Lost to Follow-up | 3 | 6 | 0 | 0 |
Death | 115 | 228 | 0 | 0 |
Withdrawal by Subject | 20 | 21 | 0 | 0 |
Reason Unspecified | 0 | 1 | 0 | 0 |
Study Ended by Sponsor | 26 | 80 | 0 | 0 |
Physician Decision | 1 | 0 | 0 | 0 |
Period Title: China Extension Period | ||||
Started | 0 | 0 | 61 [1] | 133 [2] |
Completed | 0 | 0 | 0 | 0 |
Not Completed | 0 | 0 | 61 | 133 |
Reason Not Completed | ||||
Lost to Follow-up | 0 | 0 | 2 | 3 |
Death | 0 | 0 | 46 | 88 |
Withdrawal by Subject | 0 | 0 | 8 | 6 |
Study Ended by Sponsor | 0 | 0 | 5 | 36 |
[1]
n=43 Chinese participants from the sorafenib Global population are included in the China population.
[2]
n=94 Chinese participants from the Atezolizumab + Bevacizumab Global population are included in the China population.
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Baseline Characteristics
Arm/Group Title | Sorafenib - All | Atezolizumab + Bevacizumab - All | Total | |
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Arm/Group Description | All participants either in the Global or China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | All participants either in the Global or China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | Total of all reporting groups | |
Overall Number of Baseline Participants | 183 | 375 | 558 | |
Baseline Analysis Population Description |
The intent-to-treat (ITT) population included 558 participants (All) with 501 in the Global population. An additional 57 participants enrolled in the China Extension. The China population included 137 Chinese participants from the Global population plus 57 participants from the China Extension. The Global population and China population were analyzed separately.
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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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Global | Number Analyzed | 165 participants | 336 participants | 501 participants |
64.4 (10.9) | 62.9 (11.9) | 63.4 (11.6) | ||
China | Number Analyzed | 61 participants | 133 participants | 194 participants |
57.5 (12.7) | 55.3 (12.0) | 56.0 (12.3) | ||
[1]
Measure Analysis Population Description: The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Global | Number Analyzed | 165 participants | 336 participants | 501 participants |
Female |
28 17.0%
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59 17.6%
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87 17.4%
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Male |
137 83.0%
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277 82.4%
|
414 82.6%
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China | Number Analyzed | 61 participants | 133 participants | 194 participants |
Female |
12 19.7%
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17 12.8%
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29 14.9%
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Male |
49 80.3%
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116 87.2%
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165 85.1%
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[1]
Measure Analysis Population Description: The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
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Ethnicity (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Global | Number Analyzed | 165 participants | 336 participants | 501 participants |
Hispanic or Latino |
4 2.4%
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9 2.7%
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13 2.6%
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Not Hispanic or Latino |
149 90.3%
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306 91.1%
|
455 90.8%
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Unknown or Not Reported |
12 7.3%
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21 6.3%
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33 6.6%
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China | Number Analyzed | 61 participants | 133 participants | 194 participants |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
61 100.0%
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133 100.0%
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194 100.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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[1]
Measure Analysis Population Description: The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
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Race (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Global | Number Analyzed | 165 participants | 336 participants | 501 participants |
American Indian or Alaska Native |
1 0.6%
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0 0.0%
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1 0.2%
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Asian |
96 58.2%
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188 56.0%
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284 56.7%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
4 2.4%
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6 1.8%
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10 2.0%
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White |
52 31.5%
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123 36.6%
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175 34.9%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
12 7.3%
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19 5.7%
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31 6.2%
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China | Number Analyzed | 61 participants | 133 participants | 194 participants |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
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|
Asian |
61 100.0%
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133 100.0%
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194 100.0%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
|
0 0.0%
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|
Black or African American |
0 0.0%
|
0 0.0%
|
0 0.0%
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|
White |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
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0 0.0%
|
0 0.0%
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[1]
Measure Analysis Population Description: The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
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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: | NCT03434379 |
Other Study ID Numbers: |
YO40245 2017-003691-31 ( EudraCT Number ) |
First Submitted: | January 31, 2018 |
First Posted: | February 15, 2018 |
Results First Submitted: | August 16, 2021 |
Results First Posted: | November 5, 2021 |
Last Update Posted: | October 23, 2023 |