drugset / Trial / NCT03342352
Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of the combination of nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or metastatic patients with squamous cell carcinoma of the head and neck (SCCHN) when compared to the standard of care (EXTREME regimen).
Timeline
- Start
- 2017-12-15
- Primary completion
- 2018-04-20
- Completion
- 2018-04-20
Outcome
Outcome not reported
Stopped (Enrollment): “Study was cancelled prior to enrolling any patients.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cetuximab | Monoclonal antibody | — | Intravenous |
| Subject | Epacadostat | Small molecule | — | Oral |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |