Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The primary objective of this study is to determine the progression-free survival (PFS) of participants with previously untreated metastatic malignant melanoma when treated with IMC-1121B (ramucirumab) alone or in combination with dacarbazine.
详细描述
The purpose of this study is to determine the antitumor activity and safety profile of IMC-1121B (ramucirumab) when used alone or in combination with dacarbazine in participants with metastatic melanoma who have not received prior chemotherapy for this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •The participant has histologically or cytologically confirmed melanoma that is stage IV (metastatic)
- •The participant has an Eastern Cooperative Oncology Performance Status (ECOG PS) of 0-1
- •The participant has completed any prior radiotherapy, biologic/immunotherapy or vaccine therapy (for adjuvant or advanced disease) at least six weeks prior to the first dose of study therapy
- •The participant has adequate hematological functions [absolute neutrophil count (ANC) ≥ 1500 cells/microliter (μL), hemoglobin ≥ 9 grams/deciliter (g/dL) and platelets ≥ 100,000 cells/μL].
- •The participant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN), or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases]
- •The participant has serum creatinine ≤ 1.5 x ULN [or a calculated creatinine clearance > 60 milliliters/minute (mL/min)]
- •The participant's urinary protein ≤ 1+ on dipstick or routine urinalysis [(UA); if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study]
- •The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN
- •Exclusion Criteria
- •The participant has mucosal or intra-ocular melanoma
- •The participant has known or suspected brain or leptomeningeal metastases
- •The participant has had prior cytotoxic chemotherapy for metastatic malignant melanoma
- •The participant has had more than one line of biologic, immunologic or vaccine-based therapy for metastatic malignant melanoma (including therapy for adjuvant or advanced disease)
- •The participant has a nonhealing wound or ulcer
- •The participant has a known alcohol or drug dependency
- •The participant is pregnant or breastfeeding
- •The participant has a coexisting medical or psychiatric problem of sufficient severity to limit compliance with the study and/or increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results
- •The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator
排除标准
- 未提供
研究组 & 干预措施
IMC-1121B (ramucirumab)
IMC-1121B (ramucirumab)
干预措施: IMC-1121B (ramucirumab) (Biological)
IMC-1121B (ramucirumab) + dacarbazine
IMC-1121B (ramucirumab) + dacarbazine
干预措施: IMC-1121B (ramucirumab) (Biological)
IMC-1121B (ramucirumab) + dacarbazine
IMC-1121B (ramucirumab) + dacarbazine
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline up to 36 months
PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.
次要结局
- Duration of Response(Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months)
- Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks(12 weeks (4 cycles of treatment))
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks(12 weeks (4 cycles of treatment))
- Maximum Concentration (Cmax) for Cycle 1 Day 14(Cycle 1 Day 14 (21-day cycle))
- Number of Participants With Adverse Events (AE)(Baseline up to 40 months)
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)](Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months)
- Maximum Concentration (Cmax) for Cycle 1 Day 7(Cycle 1 Day 7 (21-day cycle))
- Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks(6 weeks (2 cycles of treatment))
- Maximum Concentration (Cmax) for Cycle 1 Day 1(Cycle 1 Day 1 (21-day cycle) 1-hour post infusion)