A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo Plus Pembrolizumab or Nivolumab in Adult Patients With Unresectable Stage III or Stage IV Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab
研究概览
简要总结
This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with unresectable or metastatic melanoma and evaluate PK. Subsequently the efficacy, safety and tolerability of indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab will be studied in subjects with unresectable or metastatic melanoma in the Phase 3 portion of the trial.
The phase 3 study will not proceed per Sponsor decision.
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
- 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
- •Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma not amenable to local therapy
- •At least one radiologically measurable lesion as per RECIST 1.1
- •Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period.
- •ECOG performance status 0 or 1
- •Ability to ingest oral medications
排除标准
- •Has Ocular Melanoma
- •Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy).
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting.
- •Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
- •Has received prior radiotherapy within 2 weeks of therapy.
- •Is pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
- •Patients who have active, chronic, or on active treatment for Hep B or Hep C are excluded.
研究组 & 干预措施
Pembrolizumab + Indoximiod
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Indoximiod
干预措施: Indoximod (Drug)
Nivolumab + Indoximiod
干预措施: Nivolumab (Drug)
Nivolumab + Indoximiod
干预措施: Indoximod (Drug)
结局指标
主要结局
Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab
时间窗: 28 Days
次要结局
未报告次要终点