NCT02784483终止1 期
Pilot Study Of Anti-Programmed Death Ligand-1 (Anti-PD-L1, Atezolizumab) In Asymptomatic Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Prevalence of anti-SOX2 reactive T cells after Anti-PDL1 therapy
研究概览
简要总结
The purpose of this pilot study is to gain initial insights into the biologic and clinical effects of Atezolizumab in patients with Asymptomatic Multiple Myeloma (AMM). The data may provide novel insights into anti-PDL-1-induced immunologic changes, which could potentially be relevant to its future development in Multiple Myeloma (MM) and other indications.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:
- •Herbal therapy > 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Day 1)
- •AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia
- •Known liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
- •Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •Inability to comply with study and follow-up procedures
- •History of active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, type 1 diabetes mellitus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, glomerulonephritis or autoimmune related dermatologic disease
- •History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.).
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- •History of HIV infection or known active hepatitis B (chronic or acute) or hepatitis C infection
- •Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
- •Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- •Active tuberculosis requiring therapy.
- •Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- •Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
- •Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study
- •Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccine (e.g., FluMist™) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study.
- •Malignancies other than myeloma within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ≤ 6, and prostate-specific antigen [PSA] ≤ 10 mg/mL, etc.).
- •Medication-Related Exclusion Criteria:
- •Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents.
- •Treatment with another investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half lives of the investigational product, whichever is longer)
- •Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day
- •Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
- •The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
研究组 & 干预措施
Atezolizumab (1200mg via IV infusion)
Experimental
干预措施: Atezolizumab (1200mg via IV infusion) (Drug)
结局指标
主要结局
Prevalence of anti-SOX2 reactive T cells after Anti-PDL1 therapy
时间窗: Up to 1 year
Presence or absence of SOX2 cells before and after anti-PDL1 therapy followed up to 1 year will be measured using antigen dependant stimulation.
次要结局
未报告次要终点
研究者
研究点 (1)
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