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

Merck Sharp & Dohme LLC9 个研究点分布在 4 个国家目标入组 35 人2023年10月5日

干预措施favezelimab

概览

阶段: 1/2 期
干预措施: favezelimab
疾病 / 适应症: 未指定
发起方: Merck Sharp & Dohme LLC
入组人数: 35
试验地点: 9
主要终点: Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
状态: 招募中
最后更新: 10个月前

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.

注册库

euclinicaltrials.eu

开始日期

2023年10月5日

结束日期

待定

最后更新

10个月前

发起方

责任方

Principal Investigator

主要研究者

Pallavi Pillai

Scientific

Merck Sharp & Dohme LLC

•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)

•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