Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients will receive 3 cycles of pembrolizumab at 200mg intravenously on day 1 of a 3 week cycle. After 3 cycles the patients will undergo surgery

Pembrolizumab Injection

Daniel Catenacci, MD

To determine the pathologic complete response (pCR) rate in patients with cT1b-T2N0 GEA treated with neoadjuvant pembrolizumab followed by surgical resection.

Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma

A Phase II Trial of Neoadjuvant Pembrolizumab for Resectable Early Stage Gastroesophageal Adenocarcinoma

Determine the pCR rate in patients with gastroesophageal adenocarcinoma (GEA) treated with neoadjuvant pembrolizumab followed by surgery. Regression of the primary tumor will be documented by the amount of viable tumor verses the amount of fibrosis using Becker Criteria.

GEA patients treated with neoadjuvant pembrolizumab using proximal, distal and circumferential margins to determine the completeness of resection. The absence of tumor cells at the proximal and distal margins will be required to be classified as an R0 resection.

To determine rates of grade 1a (complete), 1b(minimal residual disease), 2 (partial response) and 3 (no response)

Evaluate the safety/tolerability patient response of pembrolizumab in patients with GEA. Number of patients with GEA taking pembrolizumab with treatment-related adverse events as assessed by CTCAE.

DFS rate measured from the time of the first pembrolizumab dose to disease recurrence or death.

Overall survival rate of patients measured from the time of first pembrolizumab dose to death.

University of Chicago

Pembrolizumab Injection: Patients will receive 3 cycles of pembrolizumab at 200mg intravenously on day 1 of a 3 week cycle. After 3 cycles the patients will undergo surgery

ARM 1

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Theodore Karrison (Research Professor)

The study was terminated due to low accrual. Data for this outcome was not collected.

Spots Global Cancer Trial Database for Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma

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Study Description

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