A Double-Blind, Randomized Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biocad
- 入组人数
- 300
- 试验地点
- 30
- 主要终点
- AUC(0-672) of nivolumab
研究概览
简要总结
The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects with advanced unresectable or metastatic melanoma of the skin. The study will have randomized, double-blind design with parallel assignment.
详细描述
Following screening, subjects will be randomized to receive either BCD-263 or Opdivo in a 1:1 ratio and enter the main study period.
During the main study period, subjects will receive therapy with BCD-263 or Opdivo, which will be administered intravenously until disease progression or signs of unacceptable toxicity develop (whichever occurs earlier).
At Week 25, after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy, or disease progression, or signs of unacceptable toxicity (whichever occurs first).
Following discontinuation of the study therapy, the subjects will enter a follow-up period, during which data on overall survival will be collected through telephone contacts.
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
- Double (Participant, Investigator)
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
- •Age ≥18 years at the time of signing the informed consent form;
- •Body weight 60 to 90 kg.
- •Histologically confirmed melanoma with the following prognostic characteristics:
- •LDH <ULN of local laboratory (enrollment of subjects with LDH <2x ULN of local laboratory is allowed until the number of subjects with LDH >ULN is 30% of the total population of randomized subjects. The Sponsor will inform when enrollment of subjects is limited by LDH level <ULN of the local laboratory).
- •Absence, according to the Investigator, of clinically significant symptoms associated with the tumor.
- •Absence, according to the Investigator, of rapidly progressing metastatic melanoma.
- •Newly diagnosed advanced unresectable (stage III) or metastatic disease (stage IV), or progressive disease during / relapsing after radical treatment.
排除标准
- •Indications for radical treatment (surgery, radiation therapy).
- •Uveal or mucosal melanoma.
- •Previous systemic anticancer therapy for advanced unresectable or metastatic skin melanoma (a history of neoadjuvant or adjuvant therapy is allowed, provided that the therapy was completed at least 12 weeks before randomization).
- •Active CNS metastases and/or carcinomatous meningitis.
- •Previous invasive cancer, excluding diseases treated with potentially curative therapy with no evidence of recurrence for 2 years from the start of this therapy (subjects with radically resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ of the uterus and other carcinomas in situ may be included).
- •Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis, bleeding or organ perforation) at the time of signing the informed consent and during the screening period.
- •Concomitant diseases and/or conditions that significantly increase the risk of adverse events (AEs) during the study.
研究组 & 干预措施
BCD-263
干预措施: BCD-263 (Drug)
Opdivo
干预措施: Opdivo (Drug)
结局指标
主要结局
AUC(0-672) of nivolumab
时间窗: pre-dose to week 25
To compare area under the drug concentration-time curve in the time interval from 0 to 672 hours after intravenous administration of BCD-263 and Opdivo
次要结局
- Ctrough(week 25)
- Safety assessment(week 25)
- AUC(0-∞)(week 25)
- Kel(week 25)
- Vd(week 25)
- Ceoi(week 25)
- Cmax(week 25)
- Tmax(week 25)
- Cl(week 25)
- Efficacy assessment: ORR(week 25)
- Efficacy assessment: PFS(week 25)
- Efficacy assessment: overall survival(week 25)
- Efficacy assessment: DCR(week 25)
- Efficacy assessment: time to response(week 25)
- Efficacy assessment: duration of response(week 25)
- T½(week 25)
- Pharmacodynamics assessment(week 25)
- Immunogenicity assessment(week 25)