Trials / Terminated
TerminatedNCT02952586
Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)
A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 697 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avelumab | Avelumab + SOC Chemoradiation |
| OTHER | Chemoradiation | Cisplatin + Radiation Therapy |
Timeline
- Start date
- 2016-11-28
- Primary completion
- 2019-12-23
- Completion
- 2020-08-25
- First posted
- 2016-11-02
- Last updated
- 2021-09-22
- Results posted
- 2021-02-24
Locations
316 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, China, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Poland, Portugal, Russia, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT02952586. Inclusion in this directory is not an endorsement.