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Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma

NCT04054518 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-08-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Durvalumab

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

Sponsors & Collaborators

  • Tiago Biachi

    lead OTHER

Principal Investigators

  • Tiago B de Castria, MD PhD · Instituto do Cancer do Estado de São Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054518 on ClinicalTrials.gov