A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF PEMBROLIZUMAB (MK-3475) PLUS CHEMOTHERAPY VERSUS CHEMOTHERAPY PLUS PLACEBO FOR THE FIRST-LINE TREATMENT OF PERSISTENT, RECURRENT, OR METASTATIC CERVICAL CANCER (KEYNOTE-826)

Merck Sharp & Dohme Corp., una subsidiaria de Mer·ck & Co. Inc.,0 个研究点目标入组 7 人开始时间: 2018年12月4日最近更新: 2024年8月20日

研究概览

暂无简介。

•1. Female participants who are at least 18 years of age on the day of signing informed consent.
•2. Have persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).
•3. Not be pregnant or breastfeeding.
•4. The participant (or legally acceptable representative if applicable) provides written informed consent for the study.
•5. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
•6. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of PD-L1 status prior to randomization.
•7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization.
•8. Have adequate organ function as per laboratory values.

•1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization.
•2.Has known active CNS metastases and/or carcinomatous meningitis.
•3.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
•4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of
•immunosuppressive therapy within 7 days prior to randomization.
•5. Has an active autoimmune disease that has required systemic treatment in past 2 years.
•6. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
•7. Has an active infection requiring systemic therapy.
•8. Has a known history of human immunodeficiency virus (HIV) infection.
•9. Has a known history of Hepatitis B or known active Hepatitis C virus infection.
•10. Has a known history of active tuberculosis.
•11 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.
•Please refer to the protocol for more information

发起方

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