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.

Esophageal Squamous Cell Carcinoma

Durvalumab (MEDI4736) will be supplied as a 500-mg vial solution for infusion after dilution.

Durvalumab

Instituto do Câncer do Estado de São Paulo

Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma

Durvalumab (MEDI4736) as Maintenance Treatment Following Chemoradiation for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (DESC).

The primary endpoint is the percentage of subjects who remain progression free at 6 months using investigator assessments according to RECIST 1.1

Incidence of grade 3 or higher toxicities graded according to NCI CTCAE (version 5.0)

Time from randomization until death from any cause.

Defined as the number of patients whose the first site of progression was in field.

Defined as the number of patients whose the first site of progression was distant.

Percentage of subjects who remain progression free at 6 months according to immune-related or response-related markers by immunohistochemistry (PD-1, PD-L1, CTLA-4, CD3, CD4, CD8, CD45RO, forkhead box P3, granzyme B, OX40, cleaved caspase 3 and Ki67).

hypothyroidism/hypoxia

Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma

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