NCT03861793已完成1 期
A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 58
- 主要终点
- Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A
研究概览
简要总结
This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.
详细描述
This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors.
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
- •For Phase I the subject has histological or cytological evidence of a solid tumor. For Phase II the subject must have 1 of the specified adult solid tumor types: gastric, ovarian, lung, head and neck.
- •Subject must have at least one target lesion based on RECIST
- •Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- •Subjects must have adequate liver function
- •Subjects must have adequate kidney function
- •Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
- •Subjects who have received radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study
- •Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered
- •Subject will agree to follow contraceptive requirements defined in the protocol
- •Additional criteria may apply
排除标准
- •Subject is currently pregnant, planning to become pregnant, or breastfeeding
- •Subjects with an active infection or with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing for Cycle 1
- •Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks, and the subject is neurologically stable
- •Subjects with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients
- •Subjects who require pharmacologic doses of systemic corticosteroids are excluded; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
- •Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and/or neuropathy
- •Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subjects to cooperate and participate in the study
- •The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis
- •Additional criteria may apply
结局指标
主要结局
Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A
时间窗: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Includes AEs that are both serious and drug-related
Number of subjects experiencing AEs that are both serious and drug-related in Part B
时间窗: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Includes AEs that are both serious and drug-related
Clinical Activity of combination treatment with ALKS 4230 and pembrolizumab in each Part B tumor type.
时间窗: From time of therapy until the date of first documented tumor progression, assessed up to 24 months
Overall Response rate (ORR) will be based on investigator review of radiographic and photographic images
次要结局
- Duration of response in subjects with CR/iCR(Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months))
- Duration of response in subjects with PR/iPR(Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months))
- Overall survival for Part B(Assessed up to 24 months)
- Proportion of subjects with objective evidence of Complete Response (CR)/immune CR (iCR)(From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months)
- Serum concentrations of ALKS 4230 will be determined at various time points(From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months)
- Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points(From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months)
- Proportion of subjects with objective evidence of Partial Response (PR)/immune PR (iPR)(From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months)
- Non-progression for Part B(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 21 days), assessed up to 24 months)
- Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points(From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months)
研究者
研究点 (58)
Loading locations...
相似试验
已完成
1 期
A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid TumorsAdvanced Solid TumorsNCT02799095Mural Oncology, Inc243
进行中（未招募）
1 期
A Phase 1/2 Study of ALKS 4230 Administered Subcutaneouslyas Monotherapy and in Combination With Pembrolizumab inSubjects With Advanced Solid Tumors(ARTISTRY-2)EUCTR2019-002013-20-DEAlkermes, Inc.257
进行中（未招募）
1 期
A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (ARTISTRY-2)Advanced Solid TumorsMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002013-20-NLAlkermes, Inc.155
进行中（未招募）
1 期
A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (ARTISTRY-2)Advanced Solid TumorsMedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0 Level: PT Classification code 10041823 Term: Squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002013-20-ESAlkermes, Inc.257
进行中（未招募）
1 期
A Phase 1/2 Study of ALKS 4230 Administered Subcutaneouslyas Monotherapy and in Combination With Pembrolizumab inSubjects With Advanced Solid Tumors(ARTISTRY-2)Advanced Solid TumorsMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10041823Term: Squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002013-20-GBAlkermes, Inc.257