A Phase II Trial of Preoperative Chemoradiotherapy and MK-3475 for Esophageal Squamous Cell Carcinoma (ACTS-29)

Yonsei University1 site in 1 country28 target enrollmentJanuary 2017

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsMK-3475(pembrolizumab)

Overview

Phase: Phase 2
Intervention: MK-3475(pembrolizumab)
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Yonsei University
Enrollment: 28
Locations: 1
Primary Endpoint: Complete Pathologic Response Rate
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

In this study, participants with esophageal squamous cell carcinoma will receive preoperative chemoradiotherapy with paclitaxel,carboplatin and pembrolizumab then undergo surgery. The primary study hypothesis is that adding pembrolizumab will increase complete pathologic response rate at surgery.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

April 26, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed ESCC
•Clinical stage T1N1-2 or T2-34aN0-12 (AJCC 7 TNM classification)
•No evidence of metastasis
•Be willing and able to provide written informed consent/assent for the trial.
•Be 20 years of age on day of signing informed consent.
•Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day
•Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
•Have a performance status of 0 or 1 on the ECOG Performance Scale.
•Demonstrate adequate organ function as defined in Table 1, 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.

Exclusion Criteria

•Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•Has a known history of active TB (Bacillus Tuberculosis)
•Hypersensitivity to pembrolizumab or any of its excipients.
•Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
•Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•Has another malignancy within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative surgery, or in situ cervical cancer.
•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). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

Arms & Interventions

pembrolizumab

Intervention: MK-3475(pembrolizumab)

Outcomes

Primary Outcomes

Complete Pathologic Response Rate

Time Frame: Up to 3 years

The primary endpoint of phase II study is to assess complete pathologic response rate. Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders"

Secondary Outcomes

Disease Free Survival(Up to 3 years)
Overall Survival(Up to 3 years)
Pathologic Response Rate(Up to 3 years)
Safety According to Common Terminology Criteria for Adverse Events (CTCAE) 4.03(Up to 3 years)
Event Free Survival(Up to 3 years)