drugset / Trial / NCT03193931
Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is designed as an open-label, randomized, prospective, multicenter, phase II study comparing pembrolizumab with methotrexate in elderly, frail or cisplatin-ineligible patients with squamous carcinoma of the head and neck (HNSCC)
Timeline
- Start
- 2018-02-02
- Primary completion
- 2021-11-24
- Completion
- 2022-03-23
Outcome
Outcome not reported
Stopped (Enrollment): “A very low recruitment rate made it impossible to reach the recruitment goal wthin an acceptable timeframe.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methotrexate | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |