Adjuvant Durvalumab for Esophageal Cancer

December 5, 2019 updated by: Jong-Mu Sun, Samsung Medical Center

Randomised, Double-blind, Phase II Trial of Adjuvant Durvalumab or Placebo for Completely Resected Esophageal Squamous Cell Carcinoma Previously Treated With Neoadjuvant Concurrent Chemoradiotherapy

Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed squamous esophageal cancer, irrespective of PD-L1 status
  • The enrolment should be done during the time interval from 20 days to 56 days after complete resection after neoadjvuant CCRT (no residual tumor after operation)
  • Clinical tumor stage before neoadjuvant CCRT should be T3-4N0M0 or T1-4N1-3M0
  • Available tumor specimen for biomarker analysis acquired before neoadjuvant CCRT or at operation

Exclusion Criteria:

  • Other PD-1 or PD-L1 inhibitors history
  • Mean QT interval corrected for heart rate (QTc) ≥470 ms using Bazett's correction
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
  • Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Durvalumab
Durvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Drug: Durvalumab
PLACEBO_COMPARATOR: Placebo
Placebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (ESTIMATE)

August 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-06-166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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