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).

Tiago Biachi

Principal Investigator

Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly

Hepatocellular Carcinoma

Pembroluzumab 200mg IV once every 3 weeks

Pembrolizumab

Bavituximab

University of Texas Southwestern Medical Center

A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

A Phase II Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

To determine the overall response rate (ORR) of combination pembrolizumab and bavituximab in patients with advanced HCC.

To determine overall survival, 6-month progression free survival, and duration of response of combination pembrolizumab and bavituximab compared to historical controls

To determine the safety and tolerability of combination pembrolizumab and bavituximab as measured by rates of adverse events according to the CTCAE

To determine treatment response with pre- and intra-treatment biopsies and plasma/serum. Correlative studies will be performed on the collected tissue and blood samples to determine if predictive markers of response can be generated

vitiligo/umor

Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma

A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

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