Trials / Completed
CompletedNCT02625623
Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)
A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) as a Third-line Treatment of Unresectable, Recurrent, or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 371 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- Gastric Cancer Third Line
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avelumab | Avelumab was administered as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2-week treatment cycle until confirmed progressive disease or unacceptable toxicity along with best supportive care (BSC). |
| DRUG | Irinotecan | Irinotecan was administered at a dose of 150 mg/m \^2 on Day 1 and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC. |
| DRUG | Paclitaxel | Paclitaxel was administered at a dose of 80 mg/m\^2 on Day 1, 8, and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC. |
| OTHER | Best Supportive Care (BSC) | BSC is defined as treatment administered with the intent to maximize Quality of life without a specific antineoplastic regimen and is based on investigator's discretion. BSC was administered once every 3 weeks. |
Timeline
- Start date
- 2015-12-28
- Primary completion
- 2017-09-14
- Completion
- 2019-11-13
- First posted
- 2015-12-09
- Last updated
- 2020-11-24
- Results posted
- 2018-10-15
Locations
75 sites across 10 countries: United States, Australia, Belgium, Czechia, France, Germany, Italy, Poland, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02625623. Inclusion in this directory is not an endorsement.