- KEYNOTE 811 FULL
- KEYNOTE 811 TRIAL
Washington University School of Medicine ( Site 0040) Minneapolis, Minnesota, United States, 55404 Minnesota Oncology Hematology, PA ( Site 8001) ( Site 0059)īeth Israel Deaconess Medical Center ( Site 0070)īoston, Massachusetts, United States, 02215ĭana-Farber Cancer Institute ( Site 0010) Southeastern Regional Medical Center, Inc. University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026) UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050) Monterey, California, United States, 93940 Los Angeles, California, United States, 90095 UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045) Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4, OX 40, Cluster of Differentiation 137 ).
Has had an allogeneic tissue/solid organ transplant. Has severe hypersensitivity (≥Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Has active or clinically significant cardiac disease. A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation. KEYNOTE 811 TRIAL
Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial. KEYNOTE 811 FULL
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. If the participant is receiving diuretic drugs for other reasons, it is acceptable Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. Has an active infection requiring systemic therapy. Has a known history of active tuberculosis (TB Mycobacterium tuberculosis). Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. Has an active autoimmune disease that has required systemic treatment in past 2 years. 
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Has had radiotherapy within 14 days of randomization. Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment. Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. Has a life expectancy of greater than 6 months. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of trial treatment. Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception. Male participants must agree to use approved contraception. Has measurable disease as defined by RECIST 1.1 as determined by the site investigator. HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor. 
Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma. Why Should I Register and Submit Results?.
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