Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)
CompletedPhase 3Results postedLast updated 24 November 2020
What this trial tests
Phase 3 trial testing Avelumab in Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in 371 participants. Completed in 13 November 2019.
18 and older, any sex, with Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma or Gastric Cancer Third Line. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Survival (OS)Primary· From randomization up to 627 days
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.
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
5.0
4.5 – 6.3
Avelumab + BSC
4.6
3.6 – 5.7
Progression Free Survival (PFS)Secondary· From randomization up to 627 days
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.
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
2.7
1.81 – 2.83
Avelumab + BSC
1.4
1.38 – 1.45
Best Overall Response (BOR)Secondary· From randomization up to 627 days
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
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
1
Avelumab + BSC
1
Physician Choice Chemotherapy + Best Supportive Care (BSC)
7
Avelumab + BSC
3
Physician Choice Chemotherapy + Best Supportive Care (BSC)
62
Avelumab + BSC
30
Physician Choice Chemotherapy + Best Supportive Care (BSC)
12
Avelumab + BSC
7
Objective Response Rate (ORR)Secondary· From randomization up to 627 days
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.
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
4.3
1.9 – 8.3
Avelumab + SC
2.2
0.6 – 5.4
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)Secondary· Baseline, EOT (up to Week 66)
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.
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
-0.103
± 0.2113
Avelumab + BSC
-0.144
± 0.2088
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)Secondary· Baseline, EOT (up to Week 66)
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.
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
-12.3
± 19.22
Avelumab + BSC
-13.6
± 19.76
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)Secondary· Baseline, EOT (up to Week 66)
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 a
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
-10.14
± 19.914
Avelumab + BSC
-15.77
± 19.437
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)Secondary· 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.
Dysphagia
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
7.25
± 28.551
Avelumab + BSC
15.32
± 29.120
Pain
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
8.88
± 22.402
Avelumab + BSC
9.23
± 21.527
Reflux
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
4.59
± 20.184
Avelumab + BSC
7.96
± 18.347
Eating Restrictions
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
9.24
± 22.661
Avelumab + BSC
13.29
± 21.276
Anxiety
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
7.49
± 21.860
Avelumab + BSC
6.61
± 19.456
Dry Mouth
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
15.94
± 27.725
Avelumab + BSC
9.01
± 28.827
Tasting
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
9.42
± 25.832
Avelumab + BSC
2.25
± 35.897
Body Image
Group
Value
95% CI
Physician Choice Chemotherapy + Best Supportive Care (BSC)
5.07
± 28.787
Avelumab + BSC
4.05
± 27.561
Adverse events — posted to ClinicalTrials.gov
Time frame: From randomization up to 627 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Physician Choice Chemotherapy + Best Supportive Care (BSC)
Serious: 81/177 (46%)
Deaths: 131/177
Avelumab + BSC
Serious: 90/184 (49%)
Deaths: 142/184
Serious adverse events (102 terms)
Reaction
System
Physician Choice Chemother…
Avelumab + BSC
Disease progression
General disorders
—
—
General physical health deterioration
General disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Pneumonia
Infections and infestations
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
Ileus
Gastrointestinal disorders
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
Asthenia
General disorders
—
—
Ascites
Gastrointestinal disorders
—
—
Dysphagia
Gastrointestinal disorders
—
—
Subileus
Gastrointestinal disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Sepsis
Infections and infestations
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Oedema peripheral
General disorders
—
—
Abdominal pain upper
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Device related infection
Infections and infestations
—
—
Herpes zoster
Infections and infestations
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study was to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician's choice (chosen from a pre-specified list of therapeutic options) plus BSC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT05687721 — Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
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NCT06518564 — Avelumab and M1774 in ARID1A-mutated Endometrial Cancer
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· recruiting
NCT06424717 — Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L
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· withdrawn
NCT06302426 — Trial of INI-4001 in Patients With Advanced Solid Tumours
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc.
Last refreshed: 24 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02625623.