[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407959":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":45,"collaborators":18,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":18,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":18,"enrollmentInfo":57,"targetDuration":18,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":18,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Yonsei University","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"olaparib+pembrolizumab+paclitaxel","EXPERIMENTAL",[12],"Drug: olaparib+pembrolizumab+paclitaxel",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DRUG","olaparib, 100\\~200mg, PO, bid, continuous Pembrolizumab 200mg, IV, q 3 weeks Paclitaxel 80mg\u002Fm2 IV, Q weekly",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Sun Young Rha, MD.Ph.D","Yonsei Cencer center, Yonsei University Collrge of Medicine","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Sun Young Rha, MD. Ph.D","CONTACT","82-2-2228-8053","rha7655@yuhs.ac",[31],{"facility":32,"status":33,"city":34,"state":18,"zip":18,"country":35,"countryCode":18,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Severance Hospital","RECRUITING","Seoul","South Korea",{"type":37,"coordinates":38},"Point",[39,40],126.9784,37.566,{"lat":40,"lon":39},[43],{"name":44,"role":27,"phone":18,"phoneExt":18,"email":18},"Sun Young Rha, Ph.D",{"type":23,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Sun Young Rha","MD, Ph.D","100407959","phase-1-pembrolizumab-olaparib-recurrentadvanced-gastric-and-gastro-esophageal-junctiongej-cancer-100407959",false,"NCT04592211","Pembrolizumab, Olaparib, Recurrent\u002FAdvanced Gastric and Gastro-esophageal Junction(GEJ) Cancer","An Open Label, Single-Arm, Multi-center Phase Ib\u002FII Study to Evaluate the Efficacy of Paclitaxel in Combination With Pembrolizumab and Olaparib as a Second Line Treatment in Immune Checkpoint Inhibitor-experienced Recurrent\u002FAdvanced Gastric and Gastro-esophageal Junction(GEJ) Cancer.","Inclusion Criteria:\n\n1. Provided written informed consent for treatment.\n2. Age ≥ 19 years old\n3. measurable or evaluable disease based on RECIST 1.1. Lesions\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient's allocation.\n5. Adequate organ function as defined by the following criteria:\n6. A life expectancy of at least 3 months\n7. Is able to swallow and retain orally administered medications\n8. Failed first-line trastuzumab treatment for HER2 positive patients\n9. Highly effective contraception for both male and female subjects if the risk of conception exists.\n10. Left ventricular ejection fraction (LVEF) ≥50%\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation\n2. Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.\n3. Has received prior radiotherapy within 2 weeks of start of study treatment.\n4. Has received a live vaccine within 30 days prior to the first dose of study drug.\n5. Is currently participating in or has participated in a study of an investigational agent including trastuzumab or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.\n8. Has known active CNS metastases and\u002For carcinomatous meningitis.\n9. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients, PARP inhibitor and paclitaxel.\n10. Has active autoimmune disease that has required systemic treatment in the past 2 years\n11. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n12. Has an active infection requiring systemic therapy.\n13. Has a known history of Human Immunodeficiency Virus (HIV).\n14. Has an active of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive and HBV titer \\>2000 IU\u002Fml) or known active Hepatitis C virus (defined as HCV RNA is detected) infection.\n15. Has an active TB (Bacillus Tuberculosis) with treatment.\n16. Participant has received previous allogenic bone-marrow, tissue\u002Fsolid organ transplant or double umbilical cord transplantation (dUCBT).","ALL","19 Years",{"count":58,"type":59},71,"ESTIMATED","INTERVENTIONAL",[62,63],"PHASE1","PHASE2","Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD 1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Olaparib is a potent PARP inhibitor (PARP1, 2, and 3) that is being developed as a monotherapy as well as for combination with chemotherapy, ionizing radiation, and other anti-cancer agents including novel agents and immunotherapy. Paclitaxel is widely used in breast, lung and gastric cancer with every 3-week or weekly cycle. Various targeted anticancer agents have been investigated with paclitaxel and combination with ramucirumab, a monoclonal anti-VEGFR2 antibody, was approved as a 2nd line treatment.",[66],"Gastric Cancer Stage IV","2025-07-09",{"date":69,"type":70},"2025-07-11","ACTUAL",{"date":72,"type":70},"2021-10-01",{"date":74,"type":59},"2026-05-31",{"name":5,"class":6},1]