NCT04592653进行中（未招募）1 期
Clinical and Immunologic Activity of Nemvaleukin Alfa With Less Frequent IV Dosing Schedule as Monotherapy and in Combination With Pembrolizumab and Impact on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 12
- 主要终点
- Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells)
研究概览
简要总结
The study will be conducted in 2 cohorts. A single-center design for the tumor microenvironment (TME) cohort (Cohort 1), and a multicenter design for the less frequent intravenous (IV) dosing cohort (Cohort 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients must have histologically or cytologically confirmed diagnosis of an advanced solid tumor type of cutaneous melanoma, RCC, TNBC, MSS colorectal cancer, MSI-H solid tumors (NOS), or ovarian cancer with at least 1 accessible lesion for biopsy (Cohort 1 TME)
- •Patients must have histologically or cytologically confirmed epithelial tumor of the fallopian tube, peritoneum, or ovaries, cervical cancer, endometrial cancer, non-small cell lung adenocarcinoma, small cell lung cancer, gastric and gastroesophageal junction adenocarcinoma, esophageal cancer (squamous and adeno cell type), pancreatic cancer, biliary tract tumor (including intra- and extrahepatic cholangiocarcinoma, gall bladder, ampullary type), cutaneous melanoma, mucosal melanoma, head and neck squamous cell carcinoma, or metastatic or advanced breast cancer after treatment failure or intolerance of 1 to 3 established indication specific therapies (Cohort 2)
- •Patient must have received 1 to 3 prior FDA-approved targeted therapies, failure of adjuvant and neoadjuvant therapy is considered 1 line of treatment
- •All patients' baseline biopsies must be taken no more than 3 months before Screening and at least 4 weeks after completion of last antineoplastic therapy
- •Patients must have at least 1 lesion that qualifies as a target lesion
- •Patients must have adequate hematologic reserve
- •Patients must have adequate hepatic and renal function
- •For Cohort 1 (TME) and Part A of Cohort 2 (less frequent IV dosing), treatment with prior immunotherapy is permitted unless the patient has previously experienced grade ≥3 autoimmune toxicity or drug-related toxicity requiring discontinuation. Patients in Part B of Cohort 2 (less frequent IV dosing) who received prior anti-PD-(L)1 for at least 3 months may enroll if they had a response of stable disease or better
- •For Cohort 1 (TME), patients who have received prior anti-PD-1 directed therapy must wait at least 4 weeks from last dose of such therapy before the Screening biopsy is collected
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test
- •Additional criteria may apply
排除标准
- •Patients with active or symptomatic central nervous system metastases
- •Patients who require pharmacologic doses of systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent)
- •Patients known to be positive for HIV and/or history of hepatitis B, or C infections or is known to be positive for hepatitis B antigen (HBsAg)/hepatitis B virus (HBV) DNA or hepatitis C antibody (Hep C Ab) or RNA.
- •Patients with a known additional malignancy within 2 years of the start of Screening
- •Patients who have received radiotherapy within the last 4 weeks before start of study treatment
- •Patients who have received systemic immunomodulatory agents within 4 weeks or 5 half lives, whichever is shorter, before Cycle 1 Day 1,
- •Patients who have received prior IL-2-based or IL-15-based soluble protein therapy at any time in the past are excluded
- •Additional criteria may apply
结局指标
主要结局
Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells)
时间窗: From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy
Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies
Changes in ratios (including T/Treg, CD8+/Treg, CD56+/Treg) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies
时间窗: From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy
Incidence of dose-limiting toxicity (DLT)
时间窗: From the first dose through end of dose-limiting toxicity observation period (up to 24 months)
次要结局
- Duration of response in subjects with Complete or Partial Response [(CR)/immune CR (iCR) or (PR) immune PR (iPR)](Time from the first documentation of complete response or partial response to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months))
- Proportion of subjects with objective evidence of Complete or Partial Response [(CR)/immune CR (iCR) or (PR) immune PR (iPR)](CR)/immune CR (iCR)(From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months)
- Incidence of drug-related Serious Adverse Events(Time from first dose of study drug to the end of study (estimated up to 24 months))
- Changes in absolute cell numbers (including total T cells, CD8+ T cells, NK cells and Treg cells)(From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months)
- Incidence of Adverse Events(Time from first dose of study drug to the end of study (estimated up to 24 months))
- Serum concentrations of ALKS 4230(From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months)
- Serum concentrations of proinflammatory cytokines, including IFNγ, TNF-α, IL-1B, IL-6, IL-10, will be assessed using a multiplex method from initiation of therapy(From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months)
- Changes in absolute numbers of circulating leukocytes(From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months)
- Incidence of drug-related Adverse Events leading to discontinuation(Time from first dose of study drug to the end of study (estimated up to 24 months))
- Changes in ratios (including T/Treg, CD8+/Treg, NK/Treg) between pretreatment and on treatment(From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months)
- Serum will be assayed for the presence of anti-ALKS 4230 antibodies(From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months)
研究者
研究点 (12)
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