Trial Outcomes & Findings for Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300) (NCT NCT02625623)

Last Updated: 2020-11-24

Results Overview

OS 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

371 participants

Primary outcome timeframe

From randomization up to 627 days

Results posted on

2020-11-24

Participant Flow

Overall, 459 participants were screened for this study. Of which, 371 participants were randomized into the study.

Participant milestones

Participant milestones
Measure	Physician Choice Chemotherapy + Best Supportive Care (BSC) 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.	Avelumab + BSC 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.
Overall Study STARTED	186	185
Overall Study Treated	177	184
Overall Study COMPLETED	177	184
Overall Study NOT COMPLETED	9	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Physician Choice Chemotherapy + Best Supportive Care (BSC) 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.	Avelumab + BSC 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.
Overall Study Participants randomized but not treated	9	1

Baseline Characteristics

Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=186 Participants 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.	Avelumab + BSC n=185 Participants 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 n=371 Participants Total of all reporting groups
Age, Continuous	60.1 Years STANDARD_DEVIATION 12.93 • n=5 Participants	58.8 Years STANDARD_DEVIATION 11.66 • n=7 Participants	59.5 Years STANDARD_DEVIATION 12.31 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	45 Participants n=7 Participants	104 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	140 Participants n=7 Participants	267 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	150 Participants n=5 Participants	153 Participants n=7 Participants	303 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized White	117 Participants n=5 Participants	119 Participants n=7 Participants	236 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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/Missing	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to 627 days

Population: FAS included all participants who were randomized to study treatment.

Outcome measures

Outcome measures
Measure	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=186 Participants 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.	Avelumab + BSC n=185 Participants 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.
Overall Survival (OS)	5.0 months Interval 4.5 to 6.3	4.6 months Interval 3.6 to 5.7

SECONDARY outcome

Timeframe: From randomization up to 627 days

Population: FAS included all participants who were randomized to study treatment.

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). 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	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=186 Participants 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.	Avelumab + BSC n=185 Participants 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.
Progression Free Survival (PFS)	2.7 months Interval 1.81 to 2.83	1.4 months Interval 1.38 to 1.45

SECONDARY outcome

Timeframe: From randomization up to 627 days

Population: FAS included all participants who were randomized to study treatment.

BOR was determined by RECIST v1.1 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 (and not qualifying for CR, PR or SD).

Outcome measures

Outcome measures
Measure	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=186 Participants 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.	Avelumab + BSC n=185 Participants 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.
Best Overall Response (BOR) Complete Response	1 Participants	1 Participants
Best Overall Response (BOR) Partial response	7 Participants	3 Participants
Best Overall Response (BOR) Stable disease	62 Participants	30 Participants
Best Overall Response (BOR) Non-complete response/ Non-progressive disease	12 Participants	7 Participants
Best Overall Response (BOR) Progressive disease	59 Participants	94 Participants
Best Overall Response (BOR) Non-evaluable	45 Participants	50 Participants

SECONDARY outcome

Timeframe: From randomization up to 627 days

Population: FAS included all participants who were randomized to study treatment.

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 adjudicated by the Independent Review Committee (IRC). 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	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=186 Participants 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.	Avelumab + BSC n=185 Participants 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.
Objective Response Rate (ORR)	4.3 percentage of participants Interval 1.9 to 8.3	2.2 percentage of participants Interval 0.6 to 5.4

SECONDARY outcome

Timeframe: Baseline, EOT (up to Week 66)

Population: Health-related quality of life (HRQoL) analysis set included a subset of the FAS and included FAS participants who met the following criteria: had 1 Baseline HRQoL assessment, had at least 1 post-Baseline HRQoL questionnaire completed. "Number of Participants Analyzed" signifies the number of participants analyzed in this 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 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	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=92 Participants 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.	Avelumab + BSC n=74 Participants 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.
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)	-0.103 units on a scale Standard Deviation 0.2113	-0.144 units on a scale Standard Deviation 0.2088

SECONDARY outcome

Timeframe: Baseline, EOT (up to Week 66)

Population: HRQoL analysis set included a subset of the FAS and included FAS participants who met the following criteria: had 1 Baseline HRQoL assessment, had at least 1 post-Baseline HRQoL questionnaire completed. "Number of Participants Analyzed" signifies the number of participants analyzed in this 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	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=92 Participants 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.	Avelumab + BSC n=74 Participants 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.
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)	-12.3 millimeter (mm) Standard Deviation 19.22	-13.6 millimeter (mm) Standard Deviation 19.76

SECONDARY outcome

Timeframe: Baseline, EOT (up to Week 66)

Population: HRQoL analysis set included a subset of the FAS and included FAS participants who met the following criteria: had 1 Baseline HRQoL assessment and had at least 1 post-Baseline HRQoL questionnaire completed. "Number of Participants Analyzed" signifies the number of participants analyzed in this outcome.

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	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=92 Participants 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.	Avelumab + BSC n=74 Participants 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.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score at End of Treatment (EOT)	-10.14 units on a scale Standard Deviation 19.914	-15.77 units on a scale Standard Deviation 19.437

SECONDARY outcome

Timeframe: Baseline, EOT (up to Week 66)

The 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	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=92 Participants 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.	Avelumab + BSC n=74 Participants 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.
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 at End of Treatment (EOT) Dysphagia	7.25 units on a scale Standard Deviation 28.551	15.32 units on a scale Standard Deviation 29.120
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 at End of Treatment (EOT) Pain	8.88 units on a scale Standard Deviation 22.402	9.23 units on a scale Standard Deviation 21.527
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 at End of Treatment (EOT) Reflux	4.59 units on a scale Standard Deviation 20.184	7.96 units on a scale Standard Deviation 18.347
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 at End of Treatment (EOT) Eating Restrictions	9.24 units on a scale Standard Deviation 22.661	13.29 units on a scale Standard Deviation 21.276
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 at End of Treatment (EOT) Anxiety	7.49 units on a scale Standard Deviation 21.860	6.61 units on a scale Standard Deviation 19.456
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 at End of Treatment (EOT) Dry Mouth	15.94 units on a scale Standard Deviation 27.725	9.01 units on a scale Standard Deviation 28.827
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 at End of Treatment (EOT) Tasting	9.42 units on a scale Standard Deviation 25.832	2.25 units on a scale Standard Deviation 35.897
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 at End of Treatment (EOT) Body Image	5.07 units on a scale Standard Deviation 28.787	4.05 units on a scale Standard Deviation 27.561
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 at End of Treatment (EOT) Hair Loss	4.71 units on a scale Standard Deviation 33.546	-13.96 units on a scale Standard Deviation 26.029

Adverse Events

Physician Choice Chemotherapy + Best Supportive Care (BSC)

Serious events: 81 serious events

Other events: 150 other events

Deaths: 131 deaths

Avelumab + BSC

Serious events: 90 serious events

Other events: 146 other events

Deaths: 142 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

Measure	Physician Choice Chemotherapy + Best Supportive Care (BSC) n=177 participants at risk 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.	Avelumab + BSC n=184 participants at risk 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.
Gastrointestinal disorders Nausea	34.5% 61/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	18.5% 34/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Gastrointestinal disorders Vomiting	18.1% 32/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	17.9% 33/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Gastrointestinal disorders Abdominal pain	17.5% 31/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	13.6% 25/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Gastrointestinal disorders Diarrhoea	30.5% 54/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	13.0% 24/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Gastrointestinal disorders Constipation	15.3% 27/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	9.8% 18/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Gastrointestinal disorders Dysphagia	1.1% 2/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	5.4% 10/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Gastrointestinal disorders Abdominal pain upper	10.2% 18/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	3.8% 7/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
General disorders Fatigue	15.8% 28/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	15.2% 28/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
General disorders Asthenia	19.8% 35/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	14.1% 26/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
General disorders Pyrexia	16.9% 30/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	11.4% 21/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
General disorders Chills	1.7% 3/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	10.3% 19/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
General disorders Oedema peripheral	9.0% 16/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	2.7% 5/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Investigations Aspartate aminotransferase increased	7.3% 13/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	8.7% 16/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Investigations Weight decreased	6.8% 12/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	8.7% 16/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Investigations Gamma-glutamyltransferase increased	7.3% 13/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	8.2% 15/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Investigations Blood alkaline phosphatase increased	5.6% 10/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	7.6% 14/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Investigations Alanine aminotransferase increased	7.3% 13/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	6.0% 11/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Investigations Neutrophil count decreased	9.0% 16/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	0.00% 0/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Investigations White blood cell count decreased	7.9% 14/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	0.00% 0/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Metabolism and nutrition disorders Decreased appetite	20.9% 37/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	15.8% 29/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Metabolism and nutrition disorders Dehydration	1.7% 3/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	5.4% 10/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Blood and lymphatic system disorders Anaemia	27.1% 48/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	16.3% 30/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Blood and lymphatic system disorders Neutropenia	14.1% 25/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	0.00% 0/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Injury, poisoning and procedural complications Infusion related reaction	1.7% 3/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	9.8% 18/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Musculoskeletal and connective tissue disorders Back pain	3.4% 6/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	9.8% 18/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 10/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	4.3% 8/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.5% 15/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	3.8% 7/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Nervous system disorders Peripheral sensory neuropathy	7.9% 14/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	0.54% 1/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.
Skin and subcutaneous tissue disorders Alopecia	14.1% 25/177 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.	0.00% 0/184 • From randomization up to 627 days All participants who received at least 1 dose of study drug (that is, treated participants) were included in safety population.