Non-Comparative, Multi-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Classical Hodgkin Lymphoma (cHL) Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 38
- 主要终点
- Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma participants.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B & C - enrollment closed)
- •Participants may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B & C - enrollment closed)
- •Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D)
排除标准
- •Known central nervous system lymphoma
- •Participants with nodular lymphocyte-predominant Hodgkin Lymphoma
- •Prior allogeneic stem cell transplantation (SCT)
- •Chest radiation ≤ 24 weeks prior to first dose
- •Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
研究组 & 干预措施
Nivolumab (Cohort A, B, C and D)
Cohort (A, B, C): Nivolumab: Specified dose on specified days
Cohort (D): Nivolumab: Specified dose on specified days + Doxorubicin: Specified dose on specified days + Vinblastine: Specified dose on specified days + Dacarbazine: Specified dose on specified days
干预措施: Nivolumab (Drug)
Nivolumab (Cohort A, B, C and D)
Cohort (A, B, C): Nivolumab: Specified dose on specified days
Cohort (D): Nivolumab: Specified dose on specified days + Doxorubicin: Specified dose on specified days + Vinblastine: Specified dose on specified days + Dacarbazine: Specified dose on specified days
干预措施: Doxorubicin (Drug)
Nivolumab (Cohort A, B, C and D)
Cohort (A, B, C): Nivolumab: Specified dose on specified days
Cohort (D): Nivolumab: Specified dose on specified days + Doxorubicin: Specified dose on specified days + Vinblastine: Specified dose on specified days + Dacarbazine: Specified dose on specified days
干预措施: Vinblastine (Drug)
Nivolumab (Cohort A, B, C and D)
Cohort (A, B, C): Nivolumab: Specified dose on specified days
Cohort (D): Nivolumab: Specified dose on specified days + Doxorubicin: Specified dose on specified days + Vinblastine: Specified dose on specified days + Dacarbazine: Specified dose on specified days
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C
时间窗: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months)
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Confidence interval based on Clopper-Pearson method.
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
时间窗: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
次要结局
- Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C(From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months))
- Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C(From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months))
- Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C(From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months).)
- Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C(From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months))
- Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C(From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months))
- Duration of PR Based on IRRC Assessments in Cohorts A, B, and C(From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months))
- Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C(From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months))
- Number of Participants With Serious Adverse Events (SAEs) in Cohort D(From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months))
- Number of Participants With AEs Leading to Discontinuation in Cohort D(From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months))
- Number of Participants With AEs Leading to Dose Delay in Cohort D(From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months))
- Treatment Discontinuation Rate in Cohort D(From first dose up until the date of treatment discontinuation (up to approximately 100 months).)
- Number of Participants Who Died in Cohort D(From first dose of the considered therapy phase to 100 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 10 months up to a maximum of 13 months))
- Number of Participants With Adverse Events (AEs) in Cohort D(From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months))
- Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase(From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months))
- Number of Participants With Select AEs in Cohort D(From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months))
- Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase(From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months))
- Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase(From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months))
- Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase(From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months))
- Complete Response (CR) Rate at Planned End of Therapy Based on IRRC Assessments in Cohort D(From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months))