drugset / Trial / NCT03193931

Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers

NCT03193931 ↗

Phase 2 Terminated 47 enrolled AIO-Studien-gGmbH
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

EvaluationDrugModalityDoseRoute
Comparator Methotrexate Small molecule 40 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous