NCT02289222终止1 期
1454GCC: Phase I/II Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma
Ashraf Badros1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The Number of Participants With Adverse Events
研究概览
简要总结
This is an open label trial of Anti PD1/MD-3475, Pomalidomide and dexamethasone. The study will use standard (FDA approved) doses for both pomalidomide and dexamethasone. The experimental drug Anti PD-1 (MK 3475) given on days 1 and 14.
详细描述
This phase I/II study is focused on patients with relapsed or refractory multiple myeloma. MK-3475 will be given as an intravenous infusion at every 2 weeks. Treatment will be administered on an outpatient basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of relapsed and/or refractory MM according to International Myeloma Working Group guidelines (2003)
- •Received two lines of prior therapy that includes an IMiD (lenalidomide or thalidomide) and a proteasome inhibitor (bortezomib and/or carfilzomib) (used either separately or in combination). (a). Prior pomalidomide therapy is permitted, provided the patient achieved at least a partial remission and had not progressed for 3 months after stopping therapy.
- •Measureable disease as defined by the protocol (assessed within 28 days prior to registration).
- •Be willing and able to provide written informed consent/assent for the trial.
- •Be over 18 years of age on day of signing informed consent.
- •Have a performance status of 2 on the ECOG Performance Scale.
- •Demonstrate adequate organ function as defined by the protocol.
- •Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study drug.
- •Male subjects should agree to use an adequate method of contraception.
排除标准
- •Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- •Has a diagnosis of immunodeficiency (HIV) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. (Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.)
- •Has 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 situ cervical cancer that has undergone potentially curative therapy.
- •Has known active central nervous system disease and/or carcinomatous meningitis.
- •Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
- •Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •Has an active infection requiring systemic therapy.
- •Has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Pregnant or breastfeeding, or expecting to conceive or father children during study participation.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody as per the protocol.
- •has known active Hepatitis B or Hepatitis C.
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- •Has received a live vaccine within 30 days prior to the first dose of trial treatment.
研究组 & 干预措施
Pomalidomide, Dexamethasone & MK-3475
Experimental
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
干预措施: MK-3475 (Drug)
Pomalidomide, Dexamethasone & MK-3475
Experimental
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
干预措施: Pomalidomide (Drug)
Pomalidomide, Dexamethasone & MK-3475
Experimental
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The Number of Participants With Adverse Events
时间窗: 24 month
Establish the safety and tolerability of Pomalidomide and Dexamethasone in combination with MK-3475
次要结局
- PD-LI Expression On Myeloma Cells(Tissue sample collection will take place before starting study therapy with MK-3475 at baseline and again at time of relapse as defined by the International Myeloma Working Group Response Criteria (Average of up to 24months))
- Time to Progression Free Survival (PFS)(PFS assessments will take place after starting study therapy with MD-3475 and will continue until the start of a new anti-neoplastic therapy, disease progression, death, or the end of study up to an average of 24 months.)
研究者
Ashraf Badros
Sponsor-Investigator
University of Maryland, Baltimore
研究点 (1)
Loading locations...
相似试验
终止
2 期
Pembrolizumab + Lenalidomide Post Autologous Stem Cell Transplant (ASCT) in High-risk Multiple Myeloma (MM)Multiple MyelomaNCT02906332Hackensack Meridian Health12
已完成
1 期
Treatment of Advanced Melanoma With MK-3475 and PeginterferonMelanomaNCT02112032Hassane M. Zarour, MD43
已完成
2 期
Pomalidomide and Dexamethasone (PDex) in AL AmyloidosisPrimary Amyloidosis of Light Chain TypeNCT01510613Fondazione IRCCS Policlinico San Matteo di Pavia28
进行中（未招募）
2 期
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior ChemotherapyEdemaErythemaEstrogen Receptor NegativeHER2/Neu NegativePeau d'OrangeProgesterone Receptor NegativeRecurrent Inflammatory Breast CarcinomaStage IV Inflammatory Breast CarcinomaTriple-Negative Breast CarcinomaNCT02411656M.D. Anderson Cancer Center71
Unknown
2 期
Study of PD-1 Inhibitor Combination With Autologous Cell Immunotherapy in the Metastatic Renal Cell CarcinomaRenal Cell CarcinomaClear Cell Renal Cell CarcinomaNCT03987698Tianjin Medical University Cancer Institute and Hospital90