EUCTR2019-002013-20-ES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) - ARTISTRY-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 257
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Subject is aged =18 years.
- •2. Subject or the subject’s legal representative provides written informed consent.
- •3. For Phase 1, Subject must have an advanced solid tumor (including lymphoma) and progressive disease following at least 1 line of therapy.
- •4. For Phase 2, subject must have one of the following tumor types or specific histology:
- •NSCLC cohort: Subjects with Stage IIIB or IV NSCLC who have been treated with checkpoint inhibitors with stable disease or better and followed by progression more than 120 days after initiation of the checkpoint inhibitor therapy.
- •SCCHN cohort: Subjects with recurrent or metastatic SCCHN with disease progression on or after chemotherapy and who have not received prior checkpoint inhibitor therapy.
- •Squamous tumor agnostic cohort: Subjects with recurrent or metastatic squamous cell carcinoma following chemotherapy and who have not received prior checkpoint inhibitor therapy. Patients with SCCHN should enroll in the SCCHN cohort if they meet those eligibility criteria.
- •HCC cohort: Subjects with recurrent or metastatic HCC with disease progression on or after antitumor therapy who have not received prior checkpoint inhibitor therapy.
- •SCLC cohort: Subjects with unresectable or metastatic SCLC who have progressed on or after a minimum of 4 cycles of chemotherapy which may have included maintenance checkpoint inhibitor therapy. Subjects who have received prior checkpoint inhibitor therapy and had stable disease or better and who subsequently progressed are eligible provided that the progression was more than 120 days of the initiation of checkpoint inhibitor therapy.
- •5. Subject must have measurable disease based on RECIST.
- •6. Subject must have completed the last dose of any broad spectrum antibiotic at least 30 days prior to first dose.
- •7. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- •8. Subject has adequate hematologic reserves, measured within 10 days prior to start of study treatment
- •9. Subject has adequate hepatic function
- •10. Subject has adequate renal function
- •11. Subject has recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, or surgery
- •12. Subject who has received standard or investigational agents must wait at least 5 half-lives or 4 weeks, whichever is shorter, before enrollment into the study or 4 weeks if the half-life of the investigational agent is not known.
- •13. Subject who has received wide-field radiotherapy must have completed at least 4 weeks before starting study drug or subject who has received focal radiation must be completed at least 2 weeks before starting study drug.
- •14. Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of the start of treatment and also on Day 1 before the first dose is administered.
- •15. Subject meets contraceptive requirements defined in Section 8.4.2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
排除标准
- •1. Subject is currently pregnant or breastfeeding or is planning to become pregnant during the study period.
- •2. Subject is employed by Alkermes, Syneos Health, the Investigator, the study center or other affiliate of this study
- •3. Subject has an active infection or a fever =38.5°C (=101°F) within 3 days of the first scheduled day of dosing for the monotherapy lead-in or Cycle 1 of Phase 2.
- •4. Subject has known hypersensitivity (Grade =3) to any components of ALKS 4230, to pembrolizumab, or any of its excipients.
- •5. Subjects with mean QT interval corrected by the Fridericia Correction Formula values of >470 msec (in females) or >450 msec (in males) following a standard 12-lead electrocardiogram (ECG); subjects who are known to have congenital prolonged QT syndromes; or subjects who are on medications known to cause prolonged QT interval on ECG.
- •6. Subject has developed autoimmune disorders while on prior immunotherapy
- •7. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- •8. Subject has active or symptomatic central nervous system metastases unless the metastases have been treated by surgery and/or radiation therapy, the subject has been tapered to a dose of 10 mg or less of corticosteroids for at least 2 weeks before the first dose, and the subject is neurologically stable.
- •9.Subject has an active autoimmune disease that has required systemic treatment in the past2 years
- •10. Subject is known to be positive for human immunodeficiency virus and/or history of hepatitis B, or C infections
- •11.Subject requires pharmacologic doses of corticosteroids (greater than 10 mg ofprednisone daily, or equivalent);
- •12.Subject has had a second malignancy within the previous 3 years.
- •13.Subject has any other concurrent uncontrolled illness, including mental illness orsubstance abuse, which may interfere with the ability of the subject to cooperate and participate in the study.
- •14.Subject has received a live vaccine within 30 days of planned start of study therapy.
- •15.Subject has active uncontrolled coagulopathy.
研究者
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进行中（未招募）
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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-FRAlkermes, Inc.257