Trials / Completed
CompletedNCT02603432
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Avelumab | 1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles |
| OTHER | Best Supportive Care | BSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable. |
| BIOLOGICAL | Following the planned interim analysis for this study: Avelumab | 1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles |
Timeline
- Start date
- 2016-04-25
- Primary completion
- 2019-10-21
- Completion
- 2023-03-28
- First posted
- 2015-11-11
- Last updated
- 2024-03-27
- Results posted
- 2020-12-17
Locations
382 sites across 29 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, France, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, South Korea, Spain, Sweden, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02603432. Inclusion in this directory is not an endorsement.