Phase 3
Completed N=499
Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
Source: ClinicalTrials.gov NCT02625610 ↗Enrolled (actual)
499
Serious AEs
34.1%
Results posted
Nov 2021
Primary outcomePrimary: Overall Survival (OS) — 10.9; 10.4 months — p=0.1779
◆ Published Evidence
Highly cited
222citations · ~44 / year
Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100.
Summary
The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.
Linked Publications (2)
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Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100.
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The current management and biomarkers of immunotherapy in advanced gastric cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
10.9; 10.4 | 0.1779 |
| SECONDARY Progression Free Survival (PFS) by Independent Review Committee (IRC) |
4.4; 3.2 | — |
| SECONDARY Best Overall Response (BOR) by Investigator Assessment |
5; 8; 31; 25; 117; 92 | — |
| SECONDARY Objective Response Rate (ORR) by Investigator Assessment |
14.4; 13.3 | — |
| SECONDARY 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) |
-0.002; 0.004; -0.032; -0.009; -0.053; -0.017 | — |
| SECONDARY 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) |
0.9; 0.6; -0.5; -2.1; -3.2; -0.7 | — |
| SECONDARY 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) |
1.30; 0.85; -1.44; -1.01; -2.50; 0.24 | — |
| SECONDARY 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) |
0.76; 0.60; 2.84; 1.34; 1.60; 0.65 | — |
| SECONDARY 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) |
214; 223; 75; 89 | — |
| SECONDARY Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values |
0; 1; 6; 1; 2; 0 | — |
| SECONDARY Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs |
57; 62; 43; 69; 14; 24 | — |
| SECONDARY Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities |
0; 1; 2; 2; 1; 3 | — |
| SECONDARY Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1 |
140; 144 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female participants greater than or equal to (>=) 18 years
- Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
- Participants with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
- Estimated life expectancy of more than 12 weeks
- Adequate haematological, hepatic and renal functions defined by the protocol
- Negative blood pregnancy test at Screening for women of childbearing potential
- Highly effective contraception for both male and female participants if the risk of conception exists
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
- Concurrent anticancer treatment or immunosuppressive agents
- Prior chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)
- Tumor shown to be human epidermal growth factor 2 plus (HER2+)
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the participant has not fully recovered from the surgery within 4 weeks of enrolment
- Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of participants with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to 3
- Pregnancy or lactation
- Known alcohol or drug abuse
- History of uncontrolled intercurrent illness including hypertension, active infection, diabetes
- Clinically significant (i.e., active) cardiovascular disease
- All other significant diseases might impair the participant's tolerance of study treatment
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements
- Vaccination with live or live/attenuated viruses within 55 days of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
- Legal incapacity or limited legal capacity
- Participants will be excluded from the Induction Phase and the Maintenance Phase if administration of their chemotherapy would be inconsistent with the current local labelling (SmPC) (e.g., in regard to contraindications, warnings/precautions or special provisions) for that chemotherapy. Investigators should check updated labelling via relevant websites at the time of entry into the Induction Phase and the Maintenance Phase
- Other protocol defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02625610) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.