Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

Phase II Trial of Durvalumab (MEDI4736 )/Tremelimumab Combined With Definitive Concurrent Chemo-radiotherapy for Inoperable Esophageal Squamous Cell Carcinoma

This is a single arm phase II study, in which 2 cycles of chemotherapy (5FU/CDDP) and immunotherapy (durvalumab and tremelimumab) are administered every 3 weeks with concurrent radiotherapy for inoperable locally advanced esophageal squamous cell carcinoma. Four weeks after completion of CCRT combined with immunotherapy, 2 cycles of durvaluma and tremelimumab will be administered every 4 weeks and thereafter durvalumab monotherapy Q4W will be maintained until unacceptable toxicity or disease progression, or for maximum 2 years after enrollment.

Study Overview

• Status: Unknown
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Durvalumab

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • MA
    • Seoul, MA, Korea, Republic of, 06351
      • Samsung Medical Center

Participation Criteria

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
• The clinical stage T2-3N0M0 or T1-3N1-3M0
• Inoperable case: it refers to medically inoperable status and/or patient's refusal to surgery and/or cervical location and/or locoregionally recurrent tumor after primary surgery
• ECOG PS of 0 to 1

Exclusion Criteria:

• clinical T4 disease (for example, invasion to aorta, vertebral body, or trachea/bronchus) or distant metastasis (M1)
• previously received radiotherapy for esophageal cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study arm; Concurrent radiotherapy with chemotherapy (5FU/CDDP) and immune checkpoint inhibitors (durvalumab/tremelimumab), and followed by consolidation immune checkpoint inhibitors	Drug: Durvalumab; concurrent radiotherapy; Other Names: Cisplatin; 5FU; tremelimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Time interval from enrollment to disease progression or death	1 year

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jong-Mu Sun, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cisplatin; Durvalumab; Tremelimumab
• Other Study ID Numbers: SMC 2017-06-138

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No