A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
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
- •Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- •Phase 1: Subjects with advanced or metastatic solid tumors.
- •Phase 1: Subjects who have disease progression after treatment with available therapies.
- •Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma.
- •Presence of measurable disease based on RECIST v1.
- •Eastern Cooperative Oncology Group performance status of 0 or 1.
排除标准
- •Laboratory and medical history parameters not within the Protocol-defined range
- •Prior treatment with any tumor necrosis factor super family agonist.
- •Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- •Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
- •Active autoimmune disease.
- •Known active central nervous system metastases and/or carcinomatous meningitis.
- •Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- •Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
- •Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
研究组 & 干预措施
INCAGN01876 + Pembrolizumab + Epacadostat
INCAGN01876 in combination with pembrolizumab and epacadostat
干预措施: INCAGN01876 (Drug)
INCAGN01876 + Pembrolizumab + Epacadostat
INCAGN01876 in combination with pembrolizumab and epacadostat
干预措施: Epacadostat (Drug)
INCAGN01876 + Pembrolizumab + Epacadostat
INCAGN01876 in combination with pembrolizumab and epacadostat
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
时间窗: Screening through 60 days after end of treatment, up to approximately 18 months
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1
时间窗: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
时间窗: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.
次要结局
- Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST(Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.)
- Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST(Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months)
- Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST(Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months)
- Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST(Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months)
- Phase 1 & Phase 2: Overall Survival(At 1 year and 2 years.)