CTIS2023-503587-17-00招募中1 期
A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies - MK-4280-003
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 140
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
- •Has measurable disease, defined as =1 lesion that can be accurately measured in 2 dimensions with diagnostic quality cross sectional anatomic imaging (computed tomography or magnetic resonance imaging). Minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis, Is able to provide a core or excisional tumor biopsy for biomarker analysis from an archival (within 3 months) or newly obtained biopsy at screening, Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
排除标准
- •Has known clinically active central nervous system (CNS) involvement, Has a known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy, Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs), Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, Has an active infection requiring intravenous systemic therapy, Has a known history of human immunodeficiency virus (HIV) infection, Has known, active hepatitis B or hepatitis C infection, Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment, Has had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years, Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody, Has received chimeric antigen receptors (CAR)-T-cell therapy for classical Hodgkin lymphoma (cHL) and diffuse large B-cell lymphoma (DLBCL) Cohorts, Has received prior anticancer therapy or thoracic radiation therapy within 14 days before the first dose of study treatment, Has =Grade 2 non-hematological residual toxicities from prior therapy, Has had a prior anticancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., =Grade 1 or at baseline) from AEs due to agents administered =4 weeks earlier, Has received a live vaccine within 30 days prior to first dose of study treatment. Administration of killed vaccines are allowed, Has received an investigational agent or used an investigational device within 4 weeks prior to intervention administration, 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 drug
研究者
相似试验
进行中（未招募）
1 期
MK-4280 and Pembrolizumab in Hematologic MalignanciesHematologic malignanciesMedDRA version: 21.1Level: LLTClassification code 10025315Term: Lymphoma malignantSystem Organ Class: 100000004864EUCTR2018-001461-16-ITMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.84
进行中（未招募）
1 期
MK-4280 and Pembrolizumab in Hematologic MalignanciesHematologic malignanciesMedDRA version: 21.1Level: LLTClassification code 10025315Term: Lymphoma malignantSystem Organ Class: 100000004864EUCTR2018-001461-16-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.84
已完成
2 期
Investigator-initiated Phase 2 clinical study of S-005151 in patients with osteoarthritis of the kneeOsteoarthritis of the kneeJPRN-jRCT2021200034Ishibashi Yasuyuki20
进行中（未招募）
1 期
A Phase II Pilot Study to Assess Safety and Efficacy of Sodium Valproate in Adults with McArdle DiseaseMcArdle disease (Glycogen storage disease type V, GSDV). The condition is an inherited disorder of skeletal muscle that causes exercise intolerance. The condition can give way to potential rhabdomyolysis which can cause acute renal failure and from middle age muscle wasting and weakness. Affected patients are unable to produce lactate during ischaemic exercise due to a congenital lack of the enzyme muscle glycogen phosphorylase which is essential for glycogen metabolism.MedDRA version: 16.1 Level: LLT Classification code 10026969 Term: McArdle's disease System Organ Class: 100000004850EUCTR2012-002933-12-GBniversity College London,8
进行中（未招募）
不适用
Study of a new drug combination to treat Chronic Lymphocytic Leukemiantreated or Relapsed Chronic Lymphocytic LeukaemiaMedDRA version: 14.1Level: LLTClassification code 10008968Term: Chronic lymphocytic leukaemia stage A(0)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005178-43-ITGLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.80