Trial Outcomes & Findings for Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100) (NCT NCT02625610)

Last Updated: 2022-06-09

Results Overview

Overall Survival was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

499 participants

Primary outcome timeframe

From randomization into maintenance phase up to 1276 days

Results posted on

2022-06-09

Participant Flow

Overall, 1284 participants were screened for this study. Of which 799 participants received at least 1 dose in the Induction Phase, 499 participants were randomized into maintenance phase of the study.

Participant milestones

Participant milestones
Measure	Chemotherapy + Best Supportive Care (BSC) Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.	Avelumab Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.
Overall Study STARTED	250	249
Overall Study Safety-Maintenance Analysis Set	238	243
Overall Study COMPLETED	250	249
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy + Best Supportive Care (BSC) n=250 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.	Avelumab n=249 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Total n=499 Participants Total of all reporting groups
Age, Continuous	60.6 Years STANDARD_DEVIATION 11.70 • n=5 Participants	60.7 Years STANDARD_DEVIATION 11.03 • n=7 Participants	60.7 Years STANDARD_DEVIATION 11.36 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	85 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	167 Participants n=5 Participants	164 Participants n=7 Participants	331 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	213 Participants n=5 Participants	220 Participants n=7 Participants	433 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	10 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized White	161 Participants n=5 Participants	171 Participants n=7 Participants	332 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	59 Participants n=5 Participants	61 Participants n=7 Participants	120 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Not collected at this site	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization into maintenance phase up to 1276 days

Population: Full analysis set included all randomized participants included in treatment arm to which they were randomized.

Outcome measures

Outcome measures
Measure	Avelumab n=249 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=250 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Overall Survival (OS)	10.4 months Interval 9.1 to 12.0	10.9 months Interval 9.6 to 12.4

SECONDARY outcome

Timeframe: From randomization into maintenance phase up to 1276 days

Population: Full analysis set included all randomized participants included in treatment arm to which they were randomized.

The PFS time was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurs first). PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as per IRC. PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Outcome measures

Outcome measures
Measure	Avelumab n=249 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=250 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Progression Free Survival (PFS) by Independent Review Committee (IRC)	3.2 months Interval 2.8 to 4.1	4.4 months Interval 4.0 to 5.5

SECONDARY outcome

Timeframe: From randomization into maintenance phase up to 1276 days

Population: Full analysis set included all randomized participants included in treatment arm to which they were randomized.

BOR was determined by RECIST v1.1 per Investigator assessment and defined as best-confirmed response of any of following: complete response (CR), partial response (PR), stable disease (SD) and PD recorded from date of randomization until disease progression or recurrence. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in SLD of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions. PR or CR confirmed at a subsequent tumor assessment, not sooner than 5 weeks after initial documentation or at an assessment later than the next assessment after the initial documentation of PR or CR. SD confirmed at least 6 weeks after randomization. Confirmed PD equal to progression \<=2 weeks after date of randomization.

Outcome measures

Outcome measures
Measure	Avelumab n=249 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=250 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Best Overall Response (BOR) by Investigator Assessment Complete response	8 Participants	5 Participants
Best Overall Response (BOR) by Investigator Assessment Partial response	25 Participants	31 Participants
Best Overall Response (BOR) by Investigator Assessment Noncomplete response/non progressive disease	10 Participants	11 Participants
Best Overall Response (BOR) by Investigator Assessment Progressive disease	85 Participants	58 Participants
Best Overall Response (BOR) by Investigator Assessment Stable disease	92 Participants	117 Participants
Best Overall Response (BOR) by Investigator Assessment Non evaluable	29 Participants	28 Participants

SECONDARY outcome

Timeframe: From randomization into maintenance phase up to 1276 days

Population: Full analysis set included all randomized participants included in treatment arm to which they were randomized.

The ORR defined as the percentage of all randomized participants with a confirmed best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1 and as per Investigator assessment. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.

Outcome measures

Outcome measures
Measure	Avelumab n=249 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=250 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Objective Response Rate (ORR) by Investigator Assessment	13.3 percentage of participants Interval 9.3 to 18.1	14.4 percentage of participants Interval 10.3 to 19.4

SECONDARY outcome

Timeframe: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)

Population: Health-related quality of life (HRQoL) analysis set included randomized participants who had 1 Maintenance Phase Baseline HRQoL assessment and had at least 1 post-Maintenance Phase Baseline HRQoL questionnaire completed. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signified those participants who were evaluable for the specified category at given time points.

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall composite health state index score, with scores ranging from -0.594 to 1. A higher score indicates better health state.

Outcome measures

Outcome measures
Measure	Avelumab n=186 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=159 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 13	-0.017 Units on Scale Standard Deviation 0.1599	-0.053 Units on Scale Standard Deviation 0.1733
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 55	0.028 Units on Scale Standard Deviation 0.2067	-0.164 Units on Scale Standard Deviation 0.2056
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 67	0.039 Units on Scale Standard Deviation 0.1954	-0.076 Units on Scale Standard Deviation 0.2347
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 3/4	0.004 Units on Scale Standard Deviation 0.1610	-0.002 Units on Scale Standard Deviation 0.1242
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 7	-0.009 Units on Scale Standard Deviation 0.1588	-0.032 Units on Scale Standard Deviation 0.1644
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 19	-0.011 Units on Scale Standard Deviation 0.1556	-0.039 Units on Scale Standard Deviation 0.1934
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 25	0.014 Units on Scale Standard Deviation 0.1518	-0.049 Units on Scale Standard Deviation 0.1797
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 31	0.013 Units on Scale Standard Deviation 0.1665	-0.023 Units on Scale Standard Deviation 0.1619
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 37	0.013 Units on Scale Standard Deviation 0.2234	-0.035 Units on Scale Standard Deviation 0.1505
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 43	0.058 Units on Scale Standard Deviation 0.1990	-0.046 Units on Scale Standard Deviation 0.1360
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 49	0.026 Units on Scale Standard Deviation 0.1936	-0.100 Units on Scale Standard Deviation 0.1796
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Week 61	0.031 Units on Scale Standard Deviation 0.1364	-0.091 Units on Scale Standard Deviation 0.2229
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) End Of Treatment	-0.138 Units on Scale Standard Deviation 0.2461	-0.125 Units on Scale Standard Deviation 0.2432
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) Safety Follow-Up	-0.099 Units on Scale Standard Deviation 0.1942	-0.062 Units on Scale Standard Deviation 0.2391

SECONDARY outcome

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.

Outcome measures

Outcome measures
Measure	Avelumab n=186 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=159 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 3/4	0.6 Millimeter Standard Deviation 13.11	0.9 Millimeter Standard Deviation 13.94
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 7	-2.1 Millimeter Standard Deviation 14.09	-0.5 Millimeter Standard Deviation 13.59
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 13	-0.7 Millimeter Standard Deviation 13.41	-3.2 Millimeter Standard Deviation 12.83
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 61	3.5 Millimeter Standard Deviation 16.15	-6.4 Millimeter Standard Deviation 18.09
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 67	4.9 Millimeter Standard Deviation 17.31	-7.3 Millimeter Standard Deviation 17.10
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) End Of Treatment	-10.3 Millimeter Standard Deviation 20.84	-12.2 Millimeter Standard Deviation 22.39
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 19	-0.1 Millimeter Standard Deviation 14.93	-3.5 Millimeter Standard Deviation 16.39
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 25	-1.4 Millimeter Standard Deviation 15.76	-4.5 Millimeter Standard Deviation 15.66
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 31	1.4 Millimeter Standard Deviation 17.61	-2.3 Millimeter Standard Deviation 13.14
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 37	0.9 Millimeter Standard Deviation 20.39	-1.7 Millimeter Standard Deviation 11.78
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 43	3.2 Millimeter Standard Deviation 15.34	-4.4 Millimeter Standard Deviation 11.92
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 49	2.1 Millimeter Standard Deviation 13.04	-2.9 Millimeter Standard Deviation 8.95
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Week 55	3.4 Millimeter Standard Deviation 16.52	-9.4 Millimeter Standard Deviation 16.32
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) Safety Follow-Up	-9.6 Millimeter Standard Deviation 20.30	-8.0 Millimeter Standard Deviation 19.24

SECONDARY outcome

European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

Outcome measures

Outcome measures
Measure	Avelumab n=186 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=160 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 61	2.38 units on a scale Standard Deviation 15.622	-5.00 units on a scale Standard Deviation 13.944
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 3/4	0.85 units on a scale Standard Deviation 15.021	1.30 units on a scale Standard Deviation 15.486
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 7	-1.01 units on a scale Standard Deviation 16.967	-1.44 units on a scale Standard Deviation 14.905
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 13	0.24 units on a scale Standard Deviation 17.637	-2.50 units on a scale Standard Deviation 15.424
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 19	1.37 units on a scale Standard Deviation 18.611	-5.85 units on a scale Standard Deviation 18.363
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 25	0.41 units on a scale Standard Deviation 16.204	-4.43 units on a scale Standard Deviation 15.407
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 31	1.85 units on a scale Standard Deviation 16.938	-3.09 units on a scale Standard Deviation 19.902
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 37	1.77 units on a scale Standard Deviation 19.293	-1.39 units on a scale Standard Deviation 22.186
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 43	3.33 units on a scale Standard Deviation 18.518	-1.19 units on a scale Standard Deviation 12.167
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 49	4.01 units on a scale Standard Deviation 15.907	1.52 units on a scale Standard Deviation 9.731
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 55	4.00 units on a scale Standard Deviation 15.426	0.00 units on a scale Standard Deviation 11.785
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Week 67	4.90 units on a scale Standard Deviation 18.413	0.00 units on a scale Standard Deviation 9.129
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) End Of Treatment	-11.67 units on a scale Standard Deviation 21.409	-11.54 units on a scale Standard Deviation 23.460
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) Safety Follow-Up	-9.29 units on a scale Standard Deviation 24.881	-7.51 units on a scale Standard Deviation 19.475

SECONDARY outcome

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.

Outcome measures

Outcome measures
Measure	Avelumab n=186 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=160 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia: Week 3/4	0.60 units on a scale Standard Deviation 15.227	0.76 units on a scale Standard Deviation 13.371
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 61	1.06 units on a scale Standard Deviation 12.123	0.00 units on a scale Standard Deviation 15.713
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 67	1.31 units on a scale Standard Deviation 17.516	-1.85 units on a scale Standard Deviation 10.924
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 3/4	-0.04 units on a scale Standard Deviation 13.465	1.51 units on a scale Standard Deviation 13.013
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 43	-1.94 units on a scale Standard Deviation 14.129	1.79 units on a scale Standard Deviation 18.251
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 49	-0.62 units on a scale Standard Deviation 12.853	1.52 units on a scale Standard Deviation 5.025
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Safety Follow-Up	10.99 units on a scale Standard Deviation 20.931	8.22 units on a scale Standard Deviation 18.011
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 13	-1.09 units on a scale Standard Deviation 15.753	0.99 units on a scale Standard Deviation 14.098
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 31	-1.29 units on a scale Standard Deviation 18.339	-2.06 units on a scale Standard Deviation 14.791
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 31	0.39 units on a scale Standard Deviation 14.880	-2.47 units on a scale Standard Deviation 15.814
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 43	-3.89 units on a scale Standard Deviation 13.443	-4.76 units on a scale Standard Deviation 18.115
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 3/4	-4.06 units on a scale Standard Deviation 18.030	-0.28 units on a scale Standard Deviation 16.150
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 7	-1.20 units on a scale Standard Deviation 20.580	-1.30 units on a scale Standard Deviation 16.947
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 43	-5.56 units on a scale Standard Deviation 16.699	-3.17 units on a scale Standard Deviation 15.364
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 7	1.34 units on a scale Standard Deviation 13.453	2.84 units on a scale Standard Deviation 15.258
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 13	0.65 units on a scale Standard Deviation 12.781	1.60 units on a scale Standard Deviation 14.090
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 19	1.52 units on a scale Standard Deviation 14.307	-0.58 units on a scale Standard Deviation 15.772
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 25	1.69 units on a scale Standard Deviation 14.852	-1.39 units on a scale Standard Deviation 10.465
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 31	4.39 units on a scale Standard Deviation 20.877	0.82 units on a scale Standard Deviation 14.755
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 37	-0.67 units on a scale Standard Deviation 14.683	-7.19 units on a scale Standard Deviation 17.977
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 43	-2.59 units on a scale Standard Deviation 13.270	-4.76 units on a scale Standard Deviation 14.265
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 49	1.23 units on a scale Standard Deviation 13.195	-3.03 units on a scale Standard Deviation 8.736
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Week 55	0.89 units on a scale Standard Deviation 13.194	0.00 units on a scale Standard Deviation 13.608
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia End Of Treatment	8.21 units on a scale Standard Deviation 22.633	7.27 units on a scale Standard Deviation 25.134
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Dysphagia Safety Follow-Up	7.25 units on a scale Standard Deviation 19.417	9.39 units on a scale Standard Deviation 21.467
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 7	2.60 units on a scale Standard Deviation 15.210	2.53 units on a scale Standard Deviation 15.351
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 13	0.16 units on a scale Standard Deviation 13.523	2.96 units on a scale Standard Deviation 14.585
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 19	-0.51 units on a scale Standard Deviation 14.088	3.22 units on a scale Standard Deviation 14.152
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 25	-1.55 units on a scale Standard Deviation 17.540	-1.56 units on a scale Standard Deviation 13.789
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 31	0.97 units on a scale Standard Deviation 18.564	4.01 units on a scale Standard Deviation 19.111
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 37	-1.26 units on a scale Standard Deviation 12.346	-4.90 units on a scale Standard Deviation 19.777
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 55	-1.00 units on a scale Standard Deviation 10.012	0.00 units on a scale Standard Deviation 19.543
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 61	-1.59 units on a scale Standard Deviation 13.596	3.33 units on a scale Standard Deviation 9.501
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain Week 67	-0.49 units on a scale Standard Deviation 15.721	0.00 units on a scale Standard Deviation 12.910
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Pain End Of Treatment	9.45 units on a scale Standard Deviation 22.960	9.25 units on a scale Standard Deviation 20.853
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 3/4	0.12 units on a scale Standard Deviation 13.571	1.04 units on a scale Standard Deviation 14.197
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 7	0.50 units on a scale Standard Deviation 17.807	0.31 units on a scale Standard Deviation 14.695
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 19	-1.68 units on a scale Standard Deviation 15.377	1.75 units on a scale Standard Deviation 17.032
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 25	1.69 units on a scale Standard Deviation 19.770	0.69 units on a scale Standard Deviation 14.648
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 37	-4.38 units on a scale Standard Deviation 17.773	-6.54 units on a scale Standard Deviation 18.864
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 49	-2.06 units on a scale Standard Deviation 16.317	1.01 units on a scale Standard Deviation 9.236
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 55	-3.56 units on a scale Standard Deviation 19.699	2.22 units on a scale Standard Deviation 4.969
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 61	-6.35 units on a scale Standard Deviation 12.944	6.67 units on a scale Standard Deviation 9.938
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Week 67	0.00 units on a scale Standard Deviation 19.245	7.41 units on a scale Standard Deviation 13.456
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux End of Treatment	4.73 units on a scale Standard Deviation 20.455	3.43 units on a scale Standard Deviation 19.529
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Reflux Safety Follow-up	2.90 units on a scale Standard Deviation 19.212	1.56 units on a scale Standard Deviation 20.254
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 3/4	0.13 units on a scale Standard Deviation 15.438	0.73 units on a scale Standard Deviation 16.279
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 7	-0.27 units on a scale Standard Deviation 15.516	0.98 units on a scale Standard Deviation 16.123
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 13	0.00 units on a scale Standard Deviation 14.023	1.02 units on a scale Standard Deviation 14.234
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 19	-0.63 units on a scale Standard Deviation 11.993	-2.34 units on a scale Standard Deviation 16.648
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 25	-1.55 units on a scale Standard Deviation 15.434	-2.08 units on a scale Standard Deviation 18.208
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 37	-3.28 units on a scale Standard Deviation 15.014	-8.82 units on a scale Standard Deviation 21.943
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 49	-5.25 units on a scale Standard Deviation 12.043	0.76 units on a scale Standard Deviation 11.459
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 55	-6.00 units on a scale Standard Deviation 12.620	3.33 units on a scale Standard Deviation 15.138
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 61	-5.56 units on a scale Standard Deviation 12.999	0.00 units on a scale Standard Deviation 15.590
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Week 67	-2.45 units on a scale Standard Deviation 19.712	1.39 units on a scale Standard Deviation 13.351
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions EOT	10.01 units on a scale Standard Deviation 22.055	8.27 units on a scale Standard Deviation 20.898
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Eating Restrictions Safety Follow-up	11.59 units on a scale Standard Deviation 25.050	7.04 units on a scale Standard Deviation 24.055
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 13	-2.83 units on a scale Standard Deviation 16.300	-0.86 units on a scale Standard Deviation 20.685
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 19	-1.68 units on a scale Standard Deviation 19.220	-1.56 units on a scale Standard Deviation 21.561
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 25	-1.69 units on a scale Standard Deviation 14.562	-2.78 units on a scale Standard Deviation 23.780
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 31	-0.52 units on a scale Standard Deviation 24.119	4.12 units on a scale Standard Deviation 23.700
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 37	-1.01 units on a scale Standard Deviation 27.409	-3.92 units on a scale Standard Deviation 20.765
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 43	-1.11 units on a scale Standard Deviation 24.474	-3.97 units on a scale Standard Deviation 22.480
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 49	-6.17 units on a scale Standard Deviation 17.792	0.00 units on a scale Standard Deviation 12.172
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 55	-4.00 units on a scale Standard Deviation 20.000	2.22 units on a scale Standard Deviation 9.296
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 61	-4.76 units on a scale Standard Deviation 24.488	-4.44 units on a scale Standard Deviation 12.669
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Week 67	-1.96 units on a scale Standard Deviation 24.918	9.26 units on a scale Standard Deviation 16.355
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety End of Treatment	5.89 units on a scale Standard Deviation 23.939	4.58 units on a scale Standard Deviation 21.868
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) Anxiety Safety Follow-Up	4.99 units on a scale Standard Deviation 26.234	5.48 units on a scale Standard Deviation 24.116

SECONDARY outcome

Timeframe: From randomization into maintenance phase up to 1276 days

Population: Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received.

Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.

Outcome measures

Outcome measures
Measure	Avelumab n=243 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=238 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) Any TEAEs	223 Participants	214 Participants
Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) Any Serious TEAE	89 Participants	75 Participants

SECONDARY outcome

Timeframe: From baseline up to 1276 days

Population: Safety-Maintenance Analysis (SMA) Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received.

Blood samples were collected for the analysis of following hematology parameters: lymphocyte count, neutrophil count, white blood cells, platelet count, lipase, serum amylase, creatinine phosphokinase and creatinine. The hematology parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case (Grade 4) post Baseline is presented. Only those participants with increase to grade 4 have been presented.

Outcome measures

Outcome measures
Measure	Avelumab n=243 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=238 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values creatinine phosphokinase increased	2 Participants	0 Participants
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values lymphocyte count decreased	1 Participants	0 Participants
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values neutrophil count decreased	1 Participants	6 Participants
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values white blood cells decreased	0 Participants	2 Participants
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values platelet count decreased	0 Participants	1 Participants
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values lipase increased	8 Participants	6 Participants
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values serum amylase increased	2 Participants	3 Participants
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values creatinine increased	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization into maintenance phase up to 1276 days

Vital signs assessment included Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Pulse Rate (PR). Number of Participants with any potentially clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	Avelumab n=243 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=238 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs Increased in Systolic blood pressure	62 Participants	57 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs Decreased in Systolic blood pressure	69 Participants	43 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs Increased in Diastolic blood pressure	24 Participants	14 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs Decreased in Diastolic blood pressure	26 Participants	21 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs Increased in pulse rate	48 Participants	46 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs Decreased in pulse rate	30 Participants	32 Participants

SECONDARY outcome

Timeframe: From randomization into maintenance phase up to 1276 days

ECG parameters included heart rate, pulse rate intervals, QRS interval, QT interval corrected based on Fridericia's formula (QTcF) intervals and QTcB intervals. Clinical significance was determined by the investigator. Number of participants with potentially clinically significant ECG abnormalities were reported.

Outcome measures

Outcome measures
Measure	Avelumab n=243 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=238 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTcB Interval: > 500 msec	3 Participants	5 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Decreased heart rate	1 Participants	0 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Increased heart rate	2 Participants	2 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Increased Pulse Rate interval	3 Participants	1 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Increased QRS interval	8 Participants	5 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTcF interval greater than (>)450milisecond (ms)less than or equal to(<=)480ms	9 Participants	9 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTcF interval: > 480 ms <= 500 ms	3 Participants	2 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTcF interval: > 500 ms	1 Participants	3 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTcB Interval: > 450 msec <= 480 msec	18 Participants	19 Participants
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTcB Interval: > 480 msec <= 500 msec	2 Participants	2 Participants

SECONDARY outcome

Timeframe: From randomization into maintenance phase up to 1276 days

ECOG PS score is widely used by doctors and researchers to assess how a participants' disease is progressing, and is used to assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 5, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair, Grade 5 = Death. Number of participants with shift in ECOG PS Score to 1 or Higher Than 1 were reported.

Outcome measures

Outcome measures
Measure	Avelumab n=243 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, 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 or discontinuation.	Chemotherapy + Best Supportive Care (BSC) n=238 Participants Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m\^2 or 400 mg/m\^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy 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.
Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1	144 Participants	140 Participants

Adverse Events

Chemotherapy + Best Supportive Care (BSC)

Serious events: 75 serious events

Other events: 203 other events

Deaths: 13 deaths

Avelumab

Serious events: 89 serious events

Other events: 191 other events

Deaths: 16 deaths

Serious adverse events

Other adverse events

Additional Information

Communication Center

Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place