NCT02631577已完成1 期
A Phase Ib/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 16
- 主要终点
- Percentage of Participants Achieving Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria
研究概览
简要总结
This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of induction treatment consisting of atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who achieve a complete response (CR), a partial response (PR), or stable disease at end of induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- •Relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
- •Histologically documented CD20-positive lymphoma as determined by the local laboratory
- •Fluorodeoxyglucose-avid lymphoma (i.e., PET-positive lymphoma)
- •At least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan or magnetic resonance imaging [MRI])
- •Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL
- •Agreement to comply with all local requirements of the lenalidomide risk minimization plan
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 18 months after the last dose of study treatment
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm for at least 3 months after the last dose of study treatment
排除标准
- •Grade 3b follicular lymphoma
- •History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)
- •Known CD20-negative status at relapse or progression
- •Central nervous system lymphoma or leptomeningeal infiltration
- •Prior allogeneic stem-cell transplantation (SCT)
- •Completion of autologous SCT within 100 days prior to Day (D) 1 of Cycle (C) 1
- •Prior standard or investigational anti-cancer therapy as specified in protocol
- •History of resistance to lenalidomide or response duration of <1 year
- •Treatment with systemic immunosuppressive medications
- •History of solid organ transplantation
- •Clinically significant toxicity from prior therapy that has not resolved to Grade <=2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.0) prior to Day 1 of Cycle 1
- •History of erythema multiforme, Grade >= 3 rash, or blistering following prior treatment with immunomodulatory derivatives such as thalidomide and lenalidomide
- •Active bacterial, viral, fungal, or other infection
- •Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
- •Known history of HIV positive status
- •History of progressive multifocal leukoencephalopathy
- •History of autoimmune disease
- •Contraindication to treatment for TE prophylaxis
- •Grade <= 2 neuropathy
- •History of other malignancy that could affect compliance with the protocol or interpretation of results
- •Evidence of any significant, uncontrolled concomitant disease
- •Inadequate hematologic function (unless due to underlying lymphoma)
- •Abnormal laboratory values (unless due to underlying lymphoma)
- •Pregnant or lactating or intending to become pregnant during the study
研究组 & 干预措施
Atezolizumab-G-lena 15mg
Experimental
Participants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide.
干预措施: Atezolizumab (MPDL3280A) [TECENTRIQ] (Drug)
Atezolizumab-G-lena 15mg
Experimental
Participants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide.
干预措施: Lenalidomide (Drug)
Atezolizumab-G-lena 15mg
Experimental
Participants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide.
干预措施: Obinutuzumab (Drug)
Atezolizumab-G-lena 20mg
Experimental
Participants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide.
干预措施: Atezolizumab (MPDL3280A) [TECENTRIQ] (Drug)
Atezolizumab-G-lena 20mg
Experimental
Participants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide.
干预措施: Lenalidomide (Drug)
Atezolizumab-G-lena 20mg
Experimental
Participants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide.
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria
时间窗: 6 months (up to clinical cut-off date (CCOD) of 23 October 2018)
Complete response (CR) was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the IRC.
次要结局
- Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of PET-CT Scans(6 months (up to CCOD of 23 October 2018))
- Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Modified Lugano 2014 Criteria(6 months (up to CCOD of 23 October 2018))
- Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Lugano 2014 Criteria(6 months (up to CCOD of 23 October 2018))
- Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of CT Scans Alone(6 months (up to CCOD of 23 October 2018))
- Percentage of Participants With Adverse Events and Serious Adverse Events(Baseline up to approximately 59 months)
- Serum Concentration of Obinutuzumab (mcg/mL)(Baseline up to approximately 59 months)
- Serum Concentration of Atezolizumab (mcg/mL)(Baseline up to approximately 59 months)
- Serum Concentration of Lenalidomide (ng/mL)(Baseline up to approximately 59 months)
- Percentage of Participants With Best Response (CR or PR) During the Study as Determined by the Investigator on the Basis of CT Scans Alone(30 months)
- Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 2 of Study Treatment(Day 1 - Day 28 of second cycle)
- Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab(Baseline up to approximately 59 months)
- Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab(Baseline up to approximately 59 months)
研究者
研究点 (16)
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