A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 19
- 主要终点
- Number of Patients With Adverse Events and Serious Adverse Events
研究概览
简要总结
This is a Phase 1b/2, open-label, multicenter study of DSP-7888 Dosing Emulsion in combination with checkpoint inhibitors (nivolumab or pembrolizumab) in adult patients with solid tumors, that consists of 2 parts: dose search part of the study (Phase 1b and Phase 1b Enrichment Cohort) and the dose expansion part of the study (Phase 2). In Phase 1b of this study there will be 2 arms: Arm 1 and Arm 2. In Arm 1, there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and nivolumab and in Arm 2 there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and pembrolizumab. In addition, an enrichment cohort of a further 10 patients who have locally advanced or metastatic Renal Cell Carcinoma or Urothelial Cancer with primary or acquired resistance to previous checkpoint inhibitors will be enrolled into Phase 1b of the study to help evaluate the preliminary antitumor activity of DSP-7888 Dosing Emulsion at the safe dose level identified in the dose-search part of the study, and will be dosed with DSP-7888 Dosing Emulsion and nivolumab, or DSP-7888 Dosing Emulsion and pembrolizumab, as per the investigator's preference. At the safe, recommended dose determined in Phase 1b, platinum-resistant ovarian cancer (PROC) patients will be enrolled in Phase 2 of the study with DSP-7888 Dosing Emulsion, exploring the combination with pembrolizumab (Arm 2). In Phase 2, approximately 40 patients with PROC will be initially enrolled; additional patients may be enrolled to further assess anti-tumor activities, but the total sample size will not exceed 60 patients. This brings the total maximum study population to approximately 84 patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DSP-7888 Dosing Emulsion in combination with Nivolumab
干预措施: DSP-7888 Dosing Emulsion (Drug)
DSP-7888 Dosing Emulsion in combination with Nivolumab
干预措施: Nivolumab (Drug)
DSP-7888 Dosing Emulsion in combination with Pembrolizumab
干预措施: DSP-7888 Dosing Emulsion (Drug)
DSP-7888 Dosing Emulsion in combination with Pembrolizumab
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Number of Patients With Adverse Events and Serious Adverse Events
时间窗: From the date of signing informed consent until 30 days after last dose for an average of 3 months.
Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs).
时间窗: 28 days
The RP2D was based on the data collected during phase 1b.
Phase II: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab in Patients With Platinum-resistant Ovarian Cancer (PROC).
时间窗: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months
Defined as the proportion of patients who have achieved confirmed Complete Response or Partial Response by RECIST v1.1 based on investigator assessment.
次要结局
- Phase Ib: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab(At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion)
- Phase Ib: The Disease Control Rate (DCR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab(At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion)
- Phase Ib: Assessment of the Duration of Response (DOR) of Ombipepimut-S in Combination With Nivolumab or Pembrolizumab(At week 4 for patients on the nivolumab arm and week 6 for patients on the pembrolizumab arm. Thereafter weeks 12, 18 and 24 and every 12 weeks until progression or death.)
- Phase Ib: Progression-free Survival (PFS) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab(Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months)
- Phase Ib: The 6-month Progression-free Survival (PFS) Rate of Ombipepimut-S in Combination With Nivolumab or Pembrolizumab(6 months)
- Phase Ib: Percentage of Patients With Overall Survival (OS) When Treated With Ombipepimut-S in Combination With Nivolumab or Pembrolizumab(12 months)
- Phase II: Assessment of the Duration of Response (DOR) of Ombipepimut-S in Combination With Pembrolizumab(Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression up to 24 months.)
- Phase II: Overall Survival of Patients Treated With Ombipepimut-S in Combination With Pembrolizumab(Every 3 months from last dose of study treatment up to 24 months.)
- Phase II: Disease Control Rate of Ombipepimut-S in Combination With Pembrolizumab(Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months.)
- Phase II: Assessment of the Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab(Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months)
- Phase II: 6-month Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab(6 months)
- Phase II: Immune Objective Response Rate (iORR) of Ombipepimut-S in Combination With Pembrolizumab(Up to 24 months)
- Phase II: Immune Progression-free Survival (iPFS) of Ombipepimut-S in Combination With Pembrolizumab(Up to 24 months)
- Phase II: Immune Duration of Response (iDOR) of Ombipepimut-S in Combination With Pembrolizumab(Up to 24 months)
- Phase II: Immune Disease Control Rate (iDCR) of Ombipepimut-S in Combination With Pembrolizumab(Up to 24 months)
- Phase II: Evaluation of the Safety and Tolerability of Ombipepimut-S in Combination With Pembrolizumab(Up to 24 months)