2023-503587-17-00招募中2 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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 9
- 主要终点
- Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
研究概览
简要总结
- To determine the safety and tolerability and to establish a preliminary recommended Phase2 dose (RP2D) of MK-4280 when used in combination with pembrolizumab.
- To determine the safety and tolerability of MK-4280 monotherapy.
- To determine the safety and tolerability of pembrolizumab monotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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
研究组 & 干预措施
favezelimab
Experimental
Participants receiving favezelimab
干预措施: favezelimab (Drug)
结局指标
主要结局
Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
Percentage of Participants Experiencing an Adverse Event (AE)
Percentage of Participants Experiencing an Adverse Event (AE)
Percentage of Participants with Treatment Discontinuations Due to an AE
Percentage of Participants with Treatment Discontinuations Due to an AE
次要结局
- Objective Response Rate (ORR)
研究者
Pallavi Pillai
Scientific
Merck Sharp & Dohme LLC
研究点 (9)
Loading locations...
相似试验
招募中
1 期
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18
招募中
2 期
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCNCT07269782Shanghai Henlius Biotech60
已完成
2 期
Phase 1/2 Study of Belzutifan Plus Palbociclib Versus Belzutifan in Advanced Renal Cell Carcinoma (RCC)2023-504963-17-00Merck Sharp & Dohme LLC76
招募中
1 期
A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal SprayNCT07259538VivaVision Biotech, Inc60
招募中
1 期
A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid TumorsNCT07265921Jiangsu Simcere Pharmaceutical Co., Ltd.232