A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)
研究概览
简要总结
A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Men and women must follow methods of contraception as described in the protocol
- •Part 1 Arms A and B: Metastatic Melanoma
- •Previously untreated, histologically confirmed stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system v.8.0
- •Part 1 Arm A:Advanced/mUC - Participants with histologically or cytologically confirmed urothelial carcinoma.
- •Part 1 Arm A: Advanced HCC
- •Participants with histological confirmation of Hepatocellular Cancer (HCC)
- •Part 2 Arm A: Metastatic NSCLC
- •Participants with histologically confirmed stage IV or recurrent Non Small Cell Lung Cancer (NSCLC)
- •Part 2 Arm B: Advanced or Metastatic RCC
- •Histological confirmation of Renal Cell Carcinoma (RCC)
- •ECOG Performance Status of 0 or 1 and for RCC (Part 2 Arm B), Karnofsky performance status ≥ 70%
排除标准
- •History of allergy or hypersensitivity to study drug components
- •Part 1 Arm A: Advanced HCC
- •History of hepatic encephalopathy or evidence of portal hypertension
- •Active coinfection with hepatitis D virus infection in participants with HBV
- •Part 2 Arm A:Metastatic NSCLC
- •Participants with known ALK translocations and EGFR mutation that are sensitive to available targeted inhibitor therapy
- •Other inclusion/exclusion criteria apply.
研究组 & 干预措施
Part 1 Arm A: mM, mUC, HCC
metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)
干预措施: ipilimumab (Drug)
Part 1 Arm A: mM, mUC, HCC
metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)
干预措施: nivolumab (Drug)
Part 1 Arm A: mM, mUC, HCC
metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)
干预措施: ENHANZE (rHuPH20) (Drug)
Part 1: Arm B: mM
metastatic Melanoma (mM)
干预措施: ipilimumab (Drug)
Part 1: Arm B: mM
metastatic Melanoma (mM)
干预措施: nivolumab (Drug)
Part 2: Arm A: NSCLC
metastatic non small cell lung cancer (NSCLC)
干预措施: ipilimumab (Drug)
Part 2: Arm A: NSCLC
metastatic non small cell lung cancer (NSCLC)
干预措施: ENHANZE (rHuPH20) (Drug)
Part 2: Arm A: NSCLC
metastatic non small cell lung cancer (NSCLC)
干预措施: nivolumab (Drug)
Part 2: Arm B: RCC
advanced or metastatic renal cell carcinoma (RCC)
干预措施: ipilimumab (Drug)
Part 2: Arm B: RCC
advanced or metastatic renal cell carcinoma (RCC)
干预措施: ENHANZE (rHuPH20) (Drug)
Part 2: Arm B: RCC
advanced or metastatic renal cell carcinoma (RCC)
干预措施: nivolumab (Drug)
结局指标
主要结局
Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)
时间窗: Day 21
Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
时间窗: Up to 21 days
Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)
时间窗: Up to 42 days
Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d)
时间窗: Day 21
Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)
时间窗: Day 21
Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d)
时间窗: Day 21
Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)
时间窗: Day 42
Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)
时间窗: Day 21
Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax)
时间窗: Up to 21 days
Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)
时间窗: Up to 21 days
Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax)
时间窗: Up to 21 days
Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)
时间窗: Day 42
Part 2 Arm A: Observed concentration in ipilimumab (C42d)
时间窗: Day 42
Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
时间窗: Up to 42 days
Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d)
时间窗: Day 21
次要结局
- Incidence of laboratory abnormalities(Up to 2.5 years)
- Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d)(Day 21)
- Incidence of AE's leading to discontinuation(Up to 2.5 years)
- Instance of hypersensitivity occurring within 2 days of study drug administration(Up to 2.5 years)
- Incidence of infusion reactions occurring within 2 days of study drug administration(Up to 2.5 years)
- Percentage of participants who develop anti-nivolumab antibodies(Up to 2.5 years)
- Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax)(Up to 21 days)
- Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d)(Day 21)
- Incidence of serious adverse events (SAEs)(Up to 5 years)
- Instance of Anaphylactic occurring within 2 days of study drug administration(Up to 2.5 years)
- Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax)(Up to 21 days)
- Incidence of hypersensitivity occurring within 2 days of study drug administration(Up to 2.5 years)
- Incidence of injection occurring within 2 days of study drug administration(Up to 2.5 years)
- Percentage of participants who have developed neutralizing antibodies(Up to 2.5 years)
- Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d)(Day 21)
- Incidence of adverse events (AE's)(Up to 2.5 years)
- Incidence of death(Up to 2.5 years)
- Percentage of participants who develop anti-ipilimumab antibodies(Up to 2.5 years)