Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)
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ClinicalTrials.gov Identifier: NCT02625623 |
Recruitment Status :
Completed
First Posted : December 9, 2015
Results First Posted : October 15, 2018
Last Update Posted : November 24, 2020
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Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )
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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 |
Conditions |
Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Gastric Cancer Third Line |
Interventions |
Drug: Avelumab Drug: Irinotecan Drug: Paclitaxel Other: Best Supportive Care (BSC) |
Enrollment | 371 |
Participant Flow
Recruitment Details | Overall, 459 participants were screened for this study. Of which, 371 participants were randomized into the study. |
Pre-assignment Details |
Arm/Group Title | Physician Choice Chemotherapy + Best Supportive Care (BSC) | Avelumab + BSC |
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Arm/Group Description | Participants received BSC plus physician's choice chemotherapy. Chemotherapy comprised of one of the following: intravenous (IV) infusion of paclitaxel at a dose of 80 milligrams per meter square (mg/m^2) on Days 1, 8 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity OR irinotecan at a dose of 150 mg/m^2 on Days 1 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity. Participants who were not deemed eligible to receive paclitaxel or irinotecan at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion. | Participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity along with BSC. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion. |
Period Title: Overall Study | ||
Started | 186 | 185 |
Treated | 177 | 184 |
Completed | 177 | 184 |
Not Completed | 9 | 1 |
Reason Not Completed | ||
Participants randomized but not treated | 9 | 1 |
Baseline Characteristics
Arm/Group Title | Physician Choice Chemotherapy + Best Supportive Care (BSC) | Avelumab + BSC | Total | |
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Arm/Group Description | Participants received BSC plus physician's choice chemotherapy. Chemotherapy comprised of one of the following: intravenous (IV) infusion of paclitaxel at a dose of 80 milligrams per meter square (mg/m^2) on Days 1, 8 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity OR irinotecan at a dose of 150 mg/m^2 on Days 1 and 15 of a 4-week treatment cycle until progressive disease or unacceptable toxicity. Participants who were not deemed eligible to receive paclitaxel or irinotecan at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion. | Participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity along with BSC. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on investigator's discretion. | Total of all reporting groups | |
Overall Number of Baseline Participants | 186 | 185 | 371 | |
Baseline Analysis Population Description |
Full analysis set (FAS) included all participants who were randomized to study treatment.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 186 participants | 185 participants | 371 participants | |
60.1 (12.93) | 58.8 (11.66) | 59.5 (12.31) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 186 participants | 185 participants | 371 participants | |
Female |
59 31.7%
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45 24.3%
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104 28.0%
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Male |
127 68.3%
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140 75.7%
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267 72.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 186 participants | 185 participants | 371 participants | |
Hispanic or Latino |
15 8.1%
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15 8.1%
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30 8.1%
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Not Hispanic or Latino |
150 80.6%
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153 82.7%
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303 81.7%
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Unknown or Not Reported |
21 11.3%
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17 9.2%
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38 10.2%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 186 participants | 185 participants | 371 participants | |
White |
117 62.9%
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119 64.3%
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236 63.6%
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Black or African American |
1 0.5%
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1 0.5%
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2 0.5%
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Asian |
47 25.3%
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47 25.4%
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94 25.3%
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American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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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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Not collected/Missing |
19 10.2%
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15 8.1%
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34 9.2%
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Other |
2 1.1%
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3 1.6%
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5 1.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Communication Center |
Organization: | Merck KGaA, Darmstadt, Germany |
Phone: | +49-6151-72-5200 |
EMail: | service@emdgroup.com |
Responsible Party: | EMD Serono ( EMD Serono Research & Development Institute, Inc. ) |
ClinicalTrials.gov Identifier: | NCT02625623 |
Other Study ID Numbers: |
EMR 100070-008 2015-003301-42 ( EudraCT Number ) |
First Submitted: | December 4, 2015 |
First Posted: | December 9, 2015 |
Results First Submitted: | September 10, 2018 |
Results First Posted: | October 15, 2018 |
Last Update Posted: | November 24, 2020 |