Trials / Terminated
TerminatedNCT03193931
Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers
A Randomized Phase II Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- AIO-Studien-gGmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab Injection | Pembrolizumab 200 mg q3w i.v. until disease progression or non-tolerable toxicity (maximum 2 years) |
| DRUG | Methotrexate Injectable Solution | Methotrexate 40 mg/m2 weekly i.v. until disease progression or non-tolerable toxicity (maximum 2 years) |
Timeline
- Start date
- 2018-02-02
- Primary completion
- 2021-11-24
- Completion
- 2022-03-23
- First posted
- 2017-06-21
- Last updated
- 2023-02-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03193931. Inclusion in this directory is not an endorsement.