EUCTR2018-001461-16-IT进行中（未招募）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 and Pembrolizumab in Hematologic Malignancies
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 84 人开始时间: 2021年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1Have meas disease,def as at least1lesion can be accurat measured in2dimens with diagn quality cross sectional anat imaging(CTorMRI).Min meas must be>15mm in the longest diameter or>10mm in the short axis
- •2Be able to provide a core or excisional tum biopsy fr biomarker analysis from an arch or newly obtained biopsy(within3months)at Screening
- •PD1/L1Naive R/RcHL(C.1)
- •3Have histol conf clas Hodgkin lymph
- •4Have relapse (def as disease progr after most recent ther)or refractory (def as failure to achieveCRorPRto most recent ther)cHL and meet at least1of the incl:
- •aHave failed to achieve a resp or progres after autoSCT.Must have relapsed after treatm with or failed to resp to brentuximab ved post autoSCT
- •bWere unable to achieve aCRorPR to salvage chemot and did not receive autoSCT.Must have relapsed after treatm with or failed to resp to brentuximab ved
- •cPts who are ineleg fr brentuximab ved, who discontinued brentit ved due to tox, or who reside in a region where brentuximab is not appr or available are eligib fr the stud
- •5Havenot prev been treated with antiPD1or antiPDL1ther
- •PD1/L1Refractory R/R cHL(C.2)
- •6Have histol confirmed clas Hodgkin lymph
- •7Have relapsed(def as disease progr after most recent ther)or refractory(def as failure to achieveCR orPR to most recent ther)cHL and meet1of the following incl:
- •aHave failed to achieve a resp or progr after autoSCT.Must have relapsed after treatm with or failed to resp to brentuximab ved post autoSCT
- •bWere unable to achieve a CRorPR to salvage chemot and did not receive autoSCT.Must have relapsed after treatm with or failed to resp to brentuximab ved
- •cPts who are ineleg fr brentuximab ved, who discontinued brentit ved due to tox, or who reside in a region where brentuximab is not approved or available are eligible fr the stud
- •8Have progr on treatm with an antiPD1/L1mAb administered either as monother or in comb with other checkpoint inhibitors or other therap.PD1 treatm progr is def by meeting all of the following criteria:
- •aHave received at least2doses of antiPD1 mAb that has been approved in Hodgkin’s lymph,with the agent administered at the approv dose and schedule
- •bHave demonstrated disease progr after PD1/L1 as def by Lymph Disease Resp criteria.Determination is made by the invest
- •cProgres disease has been doc within12w from the last dose of antiPD1/L1mAb
- •R/R DLBCL(C.3)
- •9Have a hist confirmed diagn ofDLBCL.TransfrmedDLBCL,Gray zone lymph,Double hit lymph,and Primary mediastinalBcell lymph are permitted
- •10Have progr fol at least2lines of previous ther, including progr after an autologous SCT,have declined SCT,or are not a candidate(per institutional criteria)fr an autol SCT.Pts ineleg fr standard treatm or who have withdrawn from standard treatm befre disease progr due to unaccept tox warranting discont of that treatm and precluding retreatm with the same agent will be eligible
- •R/R-iNHL(C.4)
- •11Have hist confirm diagn of indolent(low-grade)Bcell lymph,def as FL,marginal zone lymph,mucosa-associated lymphoid tissue lymph,or small lymphocytic lymph. Lymphoplasmacytic lymphs,Waldenstrom’s macroglobulinema,chronic lymphocytic leukemia(not associated with small lymphocytic lymph)and Tcell lymphs are not eligible.At least10pts must haveFL
- •12Have progr follow at least2lines of previous ther,which may include an autologous SCT.Pts ineleg fr standard treatm or who have withdrawn from standard treatm due to unaccept tox warrant discont of that treatm and precluding retreatm with the same agent befre prog
排除标准
- •1Has known clinically active central nervous system involvement
- •2A WOCBP who has a positive urine pregnancy test within 72hours prior to study intervention allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •3Has known clinically significant heart disease
- •4Has received prior therapy with an antiLAG3 antibody
- •5Has received CAR-T cells therapy
- •6Cohort 1: Has received prior therapy with an antiPD1 or antiPDL1 antibody
- •7Cohorts 2, 3, 4: Has severe hypersensitivity (=Grade3) to pembrolizumab and/or any of its excipients
- •8Has received prior anticancer therapy or thoracic radiation therapy within14days before the first dose of study intervention
- •9Grade2or higher nonhematological toxicities from prior therapy.Residual toxicity of Grade 1from prior therapy or persistent treatment-related Grade 1 neurotoxicity will be allowed
- •10Has had a prior anticancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (ie, =Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier
- •11Has received a live vaccine within 30 days prior to first dose
- •12Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days before study Day 1
- •13Has a known history of a primary immune disorder or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study intervention
- •14Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- •15Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
- •16Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- •17Has an active infection requiring intravenous systemic therapy
- •18Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
- •19Has known, active hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (hepatitis C virus [HCV] RNA [qualitative] is detected). No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority
- •20Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
- •21Is 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 intervention
- •22Has had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease)
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