Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11) - MK-3475-C11

Merck Sharp & Dohme LLC0 个研究点目标入组 146 人开始时间: 2023年6月16日最近更新: 2024年7月22日

研究概览

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•Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol, Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria, Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention, Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention

•Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL), Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, Has a history or current evidence of pulmonary fibrosis, Has had an allogenic tissue/solid organ transplant, Has an uncontrolled intercurrent cardiovascular illness, Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor, Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention, Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention, Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication, Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis, Has an active autoimmune disease that has required systemic treatment in past 2 years

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