Pegilodecakin (LY3500518) 在晚期实体瘤参与者中的 1 期研究 (IVY)
一项 1 期、开放标签剂量递增首次人体研究，以评估 AM0010 在晚期实体瘤患者中的耐受性、安全性、最大耐受剂量、初步临床活性和药代动力学
研究概览
地位
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
California
-
Los Angeles、California、美国、90024
- UCLA Medical Hematology & Oncology
-
San Francisco、California、美国
- UCSF
-
-
Colorado
-
Denver、Colorado、美国、80218
- Sarah Cannon Research Institute at HealthONE
-
-
Florida
-
Sarasota、Florida、美国、34232
- Florida Cancer Specialists & Research Institute
-
-
Massachusetts
-
Boston、Massachusetts、美国、02215
- Dana Farber Cancer Institute
-
-
New York
-
New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73104
- Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
-
-
Tennessee
-
Nashville、Tennessee、美国、37203
- Sarah Cannon Research Institute
-
-
Texas
-
Houston、Texas、美国、77030
- The University of Texas M.D. Anderson Cancer Center
-
San Antonio、Texas、美国、78229
- South Texas Accelerated Research Therapeutics
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
A 部分升级队列：
o 经组织学或细胞学证实的晚期恶性实体瘤，仅限于黑色素瘤、去势抵抗性前列腺癌 (CRPC)、卵巢癌 (OVCA)、肾细胞癌、结直肠癌 (CRC)、胰腺癌或非小细胞肺癌 (NSCLC)难治、不耐受、没有可用的治疗标准或参与者拒绝现有治疗的情况
A 部分扩展队列、B 部分和 C 部分升级和扩展队列：
- 可以登记具有所有组织学诊断或组织来源的肿瘤
参与者必须在其疾病的先前标准治愈性化学疗法中失败，拒绝现有疗法或添加了 pegilodecakin 的拟议化学疗法代表其疾病可接受的标准疗法。
- 根据 irRC 可测量或可评估的疾病或前列腺癌工作组 2 标准 (PCWG2) 可评估的去势抵抗性前列腺癌 (CRPC) 的骨转移性疾病
- 至少 18 岁
- 绩效状态 0 或 1
- 足够的器官功能
排除标准：
- 血液系统恶性肿瘤
- 怀孕或哺乳期
- 神经系统疾病的存在或病史，例如多发性硬化症和格林巴利或炎症性中枢神经系统/周围神经系统 (CNS/PNS) 疾病
- 最近 6 个月内发生过心肌梗塞
- 不稳定型心绞痛或需要药物治疗的不稳定型心律失常
- 最近 28 天内的手术
- 全身性真菌、细菌、病毒或其他感染
- 最近 6 个月内有出血素质史
- 人类免疫缺陷病毒 (HIV)、丙型肝炎或乙型肝炎呈阳性
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Part A: Pegilodecakin 0.08/0.1 mg
Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
|
|
实验性的：Part A: Pegilodecakin 0.2/0.25 mg
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
|
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
|
|
实验性的：Part A: Pegilodecakin 0.4/0.5 mg
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
|
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
|
|
实验性的：Part A: Pegilodecakin 0.8/1 mg
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
|
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
|
|
实验性的：Part A: Pegilodecakin 1.6/2 mg
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
|
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
|
|
实验性的：Part A: Pegilodecakin 3.2/4 mg
Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
|
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
|
|
实验性的：Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
其他名称：
|
|
实验性的：Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
其他名称：
|
|
实验性的：Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
其他名称：
|
|
实验性的：Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-Fluorouracil (FU) 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
其他名称：
|
|
实验性的：Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
其他名称：
|
|
实验性的：Part C: Pegilodecakin 0.8/1 mg + FOLFOX
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
其他名称：
|
|
实验性的：Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
其他名称：
|
|
实验性的：Part E: Pegilodecakin 0.8/1 mg + Capecitabine
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Capecitabine administered orally twice daily for 14 days out of every 21 days.
其他名称：
|
|
实验性的：Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
|
|
实验性的：Part G: Pegilodecakin 0.8/1 mg + Pazopanib
Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Pazopanib administered orally daily continuously
其他名称：
|
|
实验性的：Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
其他名称：
|
|
实验性的：Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
其他名称：
|
|
实验性的：Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab
Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
其他名称：
|
|
实验性的：Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an Area Under the Curve of 2 mg/mL x min (AUC2) IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
其他名称：
|
|
实验性的：Part I: Pegilodecakin 1.6/2 mg + Nivolumab
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
其他名称：
|
|
实验性的：Part I: Pegilodecakin 0.8/1 mg + Nivolumab
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
其他名称：
|
|
实验性的：Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
每天皮下注射 pegilodecakin 长达 12 个月
其他名称：
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
大体时间：From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
|
The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
|
From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
|
|
Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
大体时间：Day 29
|
Serum concentration of Pegilodecakin is reported.
|
Day 29
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Anti-Pegilodecakin Antibody Formation
大体时间：Up to 63 Months
|
Number of participants with treatment-emergent anti-Pegilodecakin antibodies, defined as participants with at least one postbaseline anti-drug antibody (ADA) titer ≥4-fold increase from baseline (treatment-boosted) or ADA present with titer ≥1:20 if baseline ADA was negative (treatment-induced), analyses were conducted in the TE ADA-evaluable population.
A participant is TE ADA evaluable if at least one non-missing ADA result is available at both baseline and postbaseline.
|
Up to 63 Months
|
|
Part A: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR). irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
|
|
Part B: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
|
|
Part C: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
|
|
Part D: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)
|
|
Part E: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months)
|
|
Part F: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months)
|
|
Part G: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
|
|
Part H: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months)
|
|
Part I: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
|
|
Part J: Number of Participants With Overall Response Rate (ORR)
大体时间：From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)
|
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)
|
合作者和调查者
合作者
调查人员
- 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company
出版物和有用的链接
一般刊物
- Naing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook GS, Pant S, Whiteside M, Rasco DR, Mumm JB, Chan IH, Bendell JC, Bauer TM, Colen RR, Hong DS, Van Vlasselaer P, Tannir NM, Oft M, Infante JR. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Oct 10;34(29):3562-3569. doi: 10.1200/JCO.2016.68.1106.
- Naing A, Wong DJ, Infante JR, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Ratti N, McCauley S, Van Vlasselaer P, Verma R, Ferry D, Oft M, Diab A, Garon EB, Tannir NM. Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial. Lancet Oncol. 2019 Nov;20(11):1544-1555. doi: 10.1016/S1470-2045(19)30514-5. Epub 2019 Sep 25.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
- 泌尿生殖系统疾病
- 生殖器疾病
- 内分泌系统疾病
- 生殖器肿瘤，男性
- 泌尿生殖系统肿瘤
- 按部位分类的肿瘤
- 生殖器疾病，男性
- 前列腺疾病
- 男性泌尿生殖系统疾病
- 肾脏疾病
- 泌尿系统疾病
- 女性泌尿生殖系统疾病
- 女性泌尿生殖系统疾病和妊娠并发症
- 肠道疾病
- 呼吸道疾病
- 组织学类型的肿瘤
- 消化道肿瘤
- 消化系统肿瘤
- 消化系统疾病
- 肠胃疾病
- 肠道肿瘤
- 直肠疾病
- 生殖器疾病，女性
- 肺部疾病
- 内分泌腺肿瘤
- 胰腺疾病
- 肿瘤、腺体和上皮
- 腺癌
- 呼吸道肿瘤
- 胸部肿瘤
- 结肠疾病
- 肺肿瘤
- 卵巢疾病
- 附件疾病
- 生殖器肿瘤，女性
- 性腺疾病
- 皮肤病
- 乳腺疾病
- 泌尿系肿瘤
- 癌
- 神经外胚层肿瘤
- 肿瘤、生殖细胞和胚胎
- 肿瘤，神经组织
- 肾脏肿瘤
- 癌，支气管癌
- 支气管肿瘤
- 神经内分泌肿瘤
- 痣和黑色素瘤
- 皮肤肿瘤
- 皮肤和结缔组织疾病
- 肿瘤
- 前列腺肿瘤
- 结直肠肿瘤
- 卵巢肿瘤
- 乳腺肿瘤
- 胰腺肿瘤
- 癌，肾细胞
- 癌，非小细胞肺癌
- 黑色素瘤
- 氨基酸，肽和蛋白质
- 蛋白质
- 有机化学品
- 杂环化合物，1形
- 杂环化合物
- 核酸，核苷酸和核苷
- 碳氢化合物
- 环磷脂
- 碳氢化合物，Alicyclic
- 碳氢化合物，循环
- 萜烯
- 抗体，单克隆，人源化
- 抗体，单克隆
- 抗体
- 免疫球蛋白
- 免疫蛋白
- 血蛋白
- 血清球蛋白
- 球蛋白
- 无机化学物质
- 氯化合物
- 氮化合物
- 协调配合物
- 税类
- 环虫
- 二萜
- 脱氧胞苷
- 胞苷
- 嘧啶核苷
- 嘧啶
- 核苷
- 乌拉西尔
- 嘧啶酮
- 白金化合物
- 脱氧核糖核苷
- 氟尿嘧啶
- 多西紫杉醇
- 卡培他滨
- 奥沙利铂
- 纳武单抗
- 吉西他滨
- 卡铂
- 紫杉醇
- 顺铂
- Pembrolizumab
- FOLFOX协议
- pazopanib
- pegilodecakin
- AM0010
其他研究编号
- 17159
- J1L-AM-JZGA (其他标识符：Eli Lilly and Company)
- AM0010-001 (其他标识符：ARMO BioSciences)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.