KCT0003913
Completed
N/A
A Phase II trial of Preoperative chemoradiotherapy and MK-3475 for Esophageal Squamous Cell Carcinoma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 28
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed stage T1N1\-2 or T2\-4a3N0\-21 (AJCC 7 TNM classification) esophageal squamous cell carcinoma (ESCC)
- •1\. Histologically confirmed esophageal squamous cell carcinoma
- •2\. Clinical stage T1N1\-2 or T2\-34aN0\-12 (AJCC 7 TNM classification)
- •3\. No evidence of metastasis
- •4\. Be willing and able to provide written informed consent/assent for the trial.
- •5\. Be ? 20 years of age on day of signing informed consent.
- •6\. 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 1\. 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.
- •7\. Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •8\. Demonstrate adequate organ function as defined in below, all screening labs should be performed within 10 days of treatment initiation.
- •Adequate Organ Function Laboratory Values
Exclusion Criteria
- •1\. Is 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.
- •2\. 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.
- •3\. Has a known history of active TB (Bacillus Tuberculosis)
- •4\. Hypersensitivity to pembrolizumab or any of its excipients.
- •5\. 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.
- •6\. 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.
- •7\. 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.
- •8\. 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.
Outcomes
Primary Outcomes
Not specified
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