A PHASE 3, RANDOMIZED, DOUBLE-BLIND CLINICAL STUDY OF PEMBROLIZUMAB (MK-3475) PLUS CHEMOTHERAPY VERSUS PLACEBO PLUS CHEMOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH HER2 NEGATIVE, PREVIOUSLY UNTREATED, UNRESECTABLE OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA (KEYNOTE-859)

Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,0 个研究点目标入组 12 人开始时间: 2018年12月7日最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•1. Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, with known PD-L1 expression status.
•2. Has HER2 negative cancer.
•3. Is at least 18 years of age at the time of signing the informed consent.
•4. Participant is:
•- a female that is not pregnant, not breastfeeding, and is either not of childbearing potential (WOCBP) OR is a WOCBP who agrees to follow the contraceptive guidance per protocol during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab or
•- a male that agrees to follow the contraceptive guidance per protocol during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab.
•5. The participant provides written informed consent for the study.
•6. Has measurable disease per RECIST 1.1 as assessed by investigator assessment.
•7. Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
•8. Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis.
•9. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 3 days prior to the start of study intervention).
•10. Has adequate organ function.

•1. Has squamous cell or undifferentiated gastric cancer.
•2. Has pre-existing peripheral neuropathy >Grade 1.
•3. Has a positive urine pregnancy test within 72 hours prior to randomization or treatment allocation.
•4. Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer.
•5. Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization.
•6. Has received prior radiotherapy within 2 weeks prior to start of study intervention.
•7. Has received a live vaccine within 30 days prior to the first dose of study intervention.
•8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years or has known active CNS metastases and/or carcinomatous meningitis.
•9. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis or has an active infection requiring systemic therapy.
•10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of
•immunosuppressive therapy within 7 days prior to the first dose of study intervention or has an active autoimmune disease that has required systemic treatment in past 2 years.
•11. Has a known history of human immunodeficiency virus (HIV) infection, known history of Hepatitis B or known active Hepatitis C virus or known history of active tuberculosis.

发起方

Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,