Trials / Active Not Recruiting
Active Not RecruitingNCT03815643
Avelumab Program Rollover Study
An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 205 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avelumab | Participants entering this roll over study will receive avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2 weeks until progressive disease, according to respective parent studies (EMR100070-001, EMR100070-002, EMR100070-004 and EMR100070-008). |
Timeline
- Start date
- 2019-03-22
- Primary completion
- 2026-08-21
- Completion
- 2026-08-21
- First posted
- 2019-01-24
- Last updated
- 2026-03-31
Locations
104 sites across 22 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Romania, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03815643. Inclusion in this directory is not an endorsement.