A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.
研究概览
简要总结
The study design included an open-label, dose escalation phase followed by a blinded, randomized phase, which combined epacadostat (an oral IDO1 inhibitor) with an approved therapy and compared to approved therapy plus placebo in metastatic melanoma patients.
Only Phase 1 of the study, dose escalation phase, was conducted. The study was terminated due to a business decision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects, aged 18 years or older with unresectable or metastatic melanoma.
- •A life expectancy of >12 weeks.
- •Laboratory ranges and medical criteria met, as defined within the protocol.
- •Subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma.
- •For Phase 2 period of the study only, Subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy.
排除标准
- •Pregnant or nursing women.
- •Current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-C or nitrosoureas.)
- •Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had Serotonin Syndrome after receiving one or more serotonergic drugs.
- •Subjects who have received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity
- •Subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis.
- •Subjects with concurrent conditions that would jeopardize the safety of the safety of the subject or compliance with the protocol.
研究组 & 干预措施
Epacadostat 100 mg
100 mg twice daily (BID) in combination with ipilimumab
干预措施: ipilimumab (Drug)
Epacadostat 100 mg
100 mg twice daily (BID) in combination with ipilimumab
干预措施: Epacadostat (Drug)
Epacadostat 300 mg
300 mg twice daily (BID) in combination with ipilimumab
干预措施: Epacadostat (Drug)
Epacadostat 300 mg
300 mg twice daily (BID) in combination with ipilimumab
干预措施: ipilimumab (Drug)
Epacadostat 75 mg
75 mg once a day (QD) in combination with ipilimumab. 75 mg total daily dose indicates 50 mg every day before noon (QAM ) and 25 mg every day after noon (QPM).
干预措施: Epacadostat (Drug)
Epacadostat 25 mg
25 mg BID in combination with ipilimumab
干预措施: Epacadostat (Drug)
Epacadostat 25 mg
25 mg BID in combination with ipilimumab
干预措施: ipilimumab (Drug)
Epacadostat 50 mg
50 mg BID in combination with ipilimumab. 50 mg BID Int indicates 50 mg BID daily 2 weeks on and 1 week off.
干预措施: ipilimumab (Drug)
Epacadostat 50 mg
50 mg BID in combination with ipilimumab. 50 mg BID Int indicates 50 mg BID daily 2 weeks on and 1 week off.
干预措施: Epacadostat (Drug)
Epacadostat 75 mg
75 mg once a day (QD) in combination with ipilimumab. 75 mg total daily dose indicates 50 mg every day before noon (QAM ) and 25 mg every day after noon (QPM).
干预措施: ipilimumab (Drug)
结局指标
主要结局
Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.
时间窗: Baseline and minimally every 3 weeks until discontinuation or death (estimated timeframe to be 29 months from first patient enrolled to last patient discontinued or dead).
Phase 2: Overall survival.
时间窗: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe to be 29 months from first patient enrolled to last patient death).
次要结局
- Preliminary efficacy as assessed by tumor response.(Baseline and every nine weeks (3 cycles) thereafter (estimated timeframe is that each patient will be on study for 11 months).)
- Evaluation of progression free survival.(Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe is that patients will progress after 11 months).)