NCT05783882进行中（未招募）3 期
Multicenter Open-label Study of the Efficacy, Pharmacokinetica and Safety of Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Biocad
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- Overall response rate
研究概览
简要总结
Multicentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with unresectable or metastatic melanoma, as well as collecting pharmacokinetics and safety data.
The study is conducted under the same conditions as the previously conducted study BCD-100-2/MIRACULUM. This means that this Study No. BCD-100-8/FLAT has identical parameters such as:
- selection criteria for subjects in the study, defining the population,
- research centers,
- procedures for evaluating effectiveness and safety,
- permitted prior and concomitant therapy of the underlying disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed informed consent and the subject's ability to comply with the protocol requirements.
- •Age ≥18 years at the time of informed consent.
- •Histologically confirmed unresectable or metastatic melanoma (with available documented evidence of relevant examinations).
- •Primarily detected advanced or metastatic melanoma, or the disease progression on or after previous systemic therapy.
- •Measurable target tumor lesions (at least 1 lesion) according to RECIST 1.1 criteria, confirmed by an independent reviewer.
- •ECOG score 0-
- •Absence of severe organ and system disorders.
- •Life expectancy of at least 12 weeks at screening.
- •For patients of childbearing potential: willingness to use reliable methods of contraception throughout the study, from the time of informed consent and for up to 6 weeks after the last dose of the study drug.
- •Available blocks for a histological examination and/or the patient's consent for collection of biopsy43 samples to obtain histological material to assess the PD-L1 status.
排除标准
- •Patients with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis) at the time of informed consent.
- •CNS metastases that are progressing or associated with clinical symptoms (e.g., cerebral edema, spinal compression) or requiring the use of glucocorticosteroids and/or anticonvulsants;
- •Ongoing concomitant diseases at the time of screening increasing the risk of severe adverse events during the study treatment.
- •The need for glucocorticoids or any other drugs with immunosuppressive effects.
- •Hematologic abnormalities.
- •Renal impairment.
- •Hepatic impairment.
- •Increased LDH >2 ULN.
- •Prior treatment with anti-CTLA4 and/or anti-PD-1/PD-L1/PDL-2 drugs.
- •Prior targeted therapy.
- •A history of malignancies, except for radically treated diseases in remission for over 5 years prior to starting the study.
- •Conditions limiting the patient's ability to comply with the protocol requirements (dementia, neurologic or mental disorders, drug or alcohol addiction, etc).
- •Simultaneous participation in other clinical studies55 or participation in other clinical studies within 30 days prior to starting the study treatmen.
- •Acute infections or activation of chronic infectious diseases within 28 days prior to the beginning of the study treatment.
- •Active hepatitis B, active hepatitis C, HIV-infection, syphilis.
- •Impossibility to administer the study drug intravenously.
- •Impossibility to perform imaging examinations requiring administration of intravenous contrast media.
- •Hypersensitivity to any of the components of BCD-
- •A history of hypersensitivity to monoclonal antibody products.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Prolgolimab (Drug)
结局指标
主要结局
Overall response rate
时间窗: 6 month
Overall response rate (partial response+complete response rates) according to RECIST 1.1
次要结局
- Overall response rate(6 month)
- Disease control rate(6 month)
- Time to response(6 month)
- Duration of Response(6 month)
研究者
研究点 (6)
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