Pembrolizumab in Post Radical Operation ESCC Patients With Lymph Node Positive ( KEYSTONE-004 )

NCT04863079 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: E20210220A
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of postoperative adjuvant treatment of pembrolizumab in patients with thoracic esophageal squamous cell carcinoma （ESCC） who have not received neoadjuvant therapy before undergoing R0 resection, and have positive postoperative lymph nodes.

Conditions

ESCC; Adjuvant Treatment; Lymph Node Positive; Pembrolizumab

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  Time from the enrollment to death of any cause

  24 months

• Disease-free survival (DFS)

  Time from the enrollment to disease relapse after complete resection or death from any cause

  24 months

Study Arms (1)

Pembrolizumab for Postoperative Adjuvant Treatment of ESCC

EXPERIMENTAL

Participants receive pembrolizumab 200 mg IV, Q3W, up to one year or disease progression or intolerance as postoperative adjuvant treatment of ESCC with pN+.

Drug: Pembrolizumab Injection [Keytruda]

Interventions

Pembrolizumab Injection [Keytruda] DRUG

Pembrolizumab 200 mg IV, Q3W, up to one year or disease progression or intolerance.

Pembrolizumab for Postoperative Adjuvant Treatment of ESCC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed ESCC;
• Patients have not received neoadjuvant therapy.
• Thoracic ESCC with R0 resection and positive postoperative lymph nodes;
• Have a performance status of 0 or 1 on the ECOG Performance Scale;
• Age 18-70 years old, both men and women;
• Be willing and able to provide written informed consent/assent for the trial;
• Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation;
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
• Be willing to provide postoperative tissue specimens. After tumor recurrence, continue to be willing to provide tissue samples such as needle biopsy.

You may not qualify if:

• Neoadjuvant therapy (radiotherapy, immunotherapy, or chemotherapy) for ESCC;
• Non-R0 resection for ESCC;
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs);
• Has severe hypersensitivity and adverse events (≥Grade 3) to pembrolizumab and/or any PD-1/PD-L1 inhibitors.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Dingzhi Huang, MD, PhD

  Tianjin Medical University Cancer Institute and Hospital

  STUDY DIRECTOR

Central Study Contacts

Hongjing Jiang, MD, PhD

CONTACT

+8618622221069; jianghongjing@tmu.edu.cn

Chuangui Chen, MD, PhD

CONTACT

+8618622228653; ccg209@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 28, 2021
• Study Start: May 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2024
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)