drugset / Trial / NCT04054518
Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
Single arm phase II trial designed to assess the efficacy of durvalumab treatment in terms of 6-month progression-free survival. We will include 22 patients who will receive 1500 mg durvalumab (MEDI4736) via IV infusion Q4W \<\<for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48\>\> or \<\<until confirmed disease progression\>\> unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. If a patient's weight falls to 30 kg or below for 1 week or longer ( ≥ 7 days) durvalumab will be permanently discontinued.
Timeline
- Start
- 2019-10-01
- Primary completion
- 2022-10-01
- Completion
- 2022-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |