A Phase 2 Study of Pembrolizumab (MK-3475) every 6 weeks (Q6W) in Participants with Relapsed or Refractory Classical Hodgkin’s Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) - MK-3475-B68

Merck Sharp & Dohme LLC0 个研究点目标入组 60 人开始时间: 2024年6月12日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Merck Sharp & Dohme LLC
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Have a histologically confirmed diagnosis of cHL or PMBCL, according to the World Health Organization (WHO) classification, Has radiographically measurable cHL or PMBCL disease as per Lugano classification with at least 1 nodal lesion (which has not been previously radiated) that is >15 mm in long axis, regardless of the length of the short axis, and/or extranodal lesion of >10 mm in long and short axis, PMBCL-Specific Disease Characteristics: •Have relapsed or refractory PMBCL and: •Have relapsed after auto-stem cell transplant (SCT), cHL-Specific Disease Characteristics: •Have relapsed or refractory cHL •Have relapsed during their last cHL regimen after receiving at least 2 cycles of therapy or within 12 months after completing the last regimen for cH

排除标准

•Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic SCT within the last 5 years, Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities, and not require corticosteroids, Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug, 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 (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 medication, Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma, Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients, Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed, Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, Has an active infection requiring systemic therapy, Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority, Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class =II), or serious cardiac arrhythmia requiring medication, Has a known history of Hepatitis B (defined as hepatitis B surface antigen (HBsAg) reactive) or known active Hepatitis C virus infection, Has pericardial effusion or clinically significant pleural effusion, Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers, Is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) <3 days prior to the first dose of study intervention. Note: Participants who receive daily steroid replacement therapy are an exception, Has received prior monoclonal antibody within 4 weeks prior to first dose of study intervention or has not recovered (i.e., =Grade 1 or at baseline) from adverse event (AEs) due to agents administered more than 4 weeks earlier, Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), Has received prior ch

研究者

发起方

Merck Sharp & Dohme LLC

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