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A Phase II Study of Preoperative Pembrolizumab for MismatchRepair Deficient, Epstein-Barr Virus Positive and/or PD-L1 Positive Gastric Cancer followed by Chemotherapy and Chemoradiation with Pembrolizumab

Primary Objective
To assess efficacy (disease-free survival) of operable gastric cancer treated with PD-1 blockade using pembrolizumab

Secondary Objective(s)

(1) To characterize the safety and tolerability of pembrolizumab in the preoperative setting and postoperative setting with chemoradiation
(2) To evaluate recurrence rates and patterns of recurrence/metastasis
(3) To characterize adverse events (AE) of pembrolizumab in combination with radiation therapy and capecitabine
(4) To evaluate overall survival rates

Exploratory Objective
(1) To assess T cell responses and pathological responses in the tumor specimen
(2) To correlate PD-L1 expression in tumor tissue and stroma with tumor tissue response
(3) To evaluate RNA expression via Nanostring technology with tumor tissue response

Protocol Number: 071702
Phase: Phase II
Applicable Disease Sites: Stomach
Drugs Involved: Pembrolizumab (MK-3475)
CAPECITABINE
Principal Investigator: Salma Jabbour M.D.
Scope: Local
Therapies Involved: Radiotherapy
Chemotherapy (NOS)
Surgery
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
    • Principal Investigator
      • Salma Jabbour M.D.
  • Emory University
  • Montefiore Medical Center
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria. For additional information on this trial or other available clinical trials please contact the research nurse.

For further information about clinical trials, please contact us at 732-235-7356.