drugset / Trial / NCT04054518

Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma

NCT04054518 ↗

Phase 2 Unknown 22 enrolled Tiago Biachi
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

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous