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Bmab1700与Opdivo®作为黑色素瘤参与者辅助单药治疗的药代动力学、安全性和免疫原性比较

2026年9月24日 更新者：Biocon Biologics UK PLC

一项随机、双盲、平行、多中心、双臂研究，旨在比较完全切除IIB/C期、III期或IV期黑色素瘤后Bmab1700与Opdivo®的药代动力学、安全性和免疫原性

The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This study consists of 2 treatment periods: Double-Blind Treatment Period (DB-TP, Week 0 to Week 24 Predose) and Open-Label Treatment Period (OL-TP, From Week 24 Dosing to Week 52). Participants will be randomized in a ratio of 1:1 ratio to receive intravenous infusion of either Bmab1700 (test) or Opdivo (reference) every 4 weeks (Q4W) in DB-TP until disease relapse or recurrence, unacceptable toxicity, or Week 20, whichever occurs earlier. At Week 24, after completing all pre-dose assessments, participants who will remain on study will receive Bmab1700 Q4W until Week 48 end of treatment (EOT) of OL-TP [EOT-OL-TP]. The end-of-study (EOS) for OL-TP (EOS-OL-TP) will then occur at Week 52.

研究类型

介入性

注册 (估计的)

120

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 乌克兰
      • Ivano-Frankivsk、乌克兰
        • 尚未招聘
        • Biocon Investigational Site
      • Kyiv、乌克兰
        • 尚未招聘
        • Biocon Investigational Site
  • 乔治亚州
      • Batumi、乔治亚州
        • 尚未招聘
        • Biocon Investigational Site
      • Kutaisi、乔治亚州
        • 尚未招聘
        • Biocon Investigational Site
      • Tbilisi、乔治亚州
        • 尚未招聘
        • Biocon Investigational Site 1
      • Tbilisi、乔治亚州
        • 尚未招聘
        • Biocon Investigational Site 3
      • Tbilisi、乔治亚州
        • 尚未招聘
        • Biocon Investigational Site 4
      • Tbilisi、乔治亚州
        • 尚未招聘
        • Biocon Investigational Site 5
      • Tbilisi、乔治亚州
        • 尚未招聘
        • Biocon Investigational Site
  • 南非
      • George、南非
        • 尚未招聘
        • Biocon Investigational Site
      • Johannesburg、南非
        • 尚未招聘
        • Biocon Investigational Site 1
      • Johannesburg、南非
        • 尚未招聘
        • Biocon Investigational Site
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）
        • 尚未招聘
        • Biocon Investigational Site
      • Bornova、土耳其（türkiye）
        • 尚未招聘
        • Biocon Investigational Site
      • Konak、土耳其（türkiye）
        • 尚未招聘
        • Biocon Investigational Site
  • 塞尔维亚
      • Belgrade、塞尔维亚
        • 招聘中
        • Biocon Investigational Site 1
      • Belgrade、塞尔维亚
        • 尚未招聘
        • Biocon Investigational Site
      • Kamenitz、塞尔维亚
        • 尚未招聘
        • Biocon Investigational Site
      • Kragujevac、塞尔维亚
        • 招聘中
        • Biocon Investigational Site
      • Niš、塞尔维亚
        • 尚未招聘
        • Biocon Investigational Site
  • 巴西
      • Bento Gonçalves、巴西
        • 尚未招聘
        • Biocon Investigational Site
      • Ijuí、巴西
        • 尚未招聘
        • Biocon Investigational Site
      • Pará、巴西
        • 尚未招聘
        • Biocon Investigational Site
      • Porto Alegre、巴西
        • 尚未招聘
        • Biocon Investigational Site
      • Rio de Janeiro、巴西
        • 尚未招聘
        • Biocon Investigational Site
      • Santa Catarina、巴西
        • 尚未招聘
        • Biocon Investigational Site 1
      • Santa Catarina、巴西
        • 尚未招聘
        • Biocon Investigational Site 2
      • Santa Catarina、巴西
        • 尚未招聘
        • Biocon Investigational Site
      • São Paulo、巴西
        • 尚未招聘
        • Biocon Investigational Site 1
      • São Paulo、巴西
        • 尚未招聘
        • Biocon Investigational Site 2
      • São Paulo、巴西
        • 尚未招聘
        • Biocon Investigational Site
  • 摩尔多瓦
      • Chisinau、摩尔多瓦
        • 尚未招聘
        • Biocon Investigational Site
  • 智利
      • Providencia、智利
        • 尚未招聘
        • Biocon Investigational Site
      • Recoleta、智利
        • 尚未招聘
        • Biocon Investigational Site
      • Santiago、智利
        • 尚未招聘
        • Biocon Investigational Site 1
      • Santiago、智利
        • 尚未招聘
        • Biocon Investigational Site
  • 罗马尼亚
      • Bucharest、罗马尼亚
        • 尚未招聘
        • Biocon Investigational Site
      • Cluj-Napoca、罗马尼亚
        • 尚未招聘
        • Site 26
      • Craiova、罗马尼亚
        • 尚未招聘
        • Biocon Investigational Site
  • 西班牙
      • Barcelona、西班牙
        • 尚未招聘
        • Biocon Investigational Site 1
      • Barcelona、西班牙
        • 尚未招聘
        • Biocon Investigational Site
      • Madrid、西班牙
        • 尚未招聘
        • Biocon Investigational Site
      • Murcia、西班牙
        • 尚未招聘
        • Biocon Investigational Site
      • Sabadell、西班牙
        • 尚未招聘
        • Biocon Investigational Site
      • Seville、西班牙
        • 尚未招聘
        • Biocon Investigational Site 1
      • Seville、西班牙
        • 尚未招聘
        • Biocon Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Participants greater than or equal to (>=)18 years of age on the day of signing informed consent (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
  2. Able to understand and willing to provide consent using the study Informed Consent Form (ICF). The voluntarily signed ICF must be obtained before any study-specific procedures are performed.
  3. Histologically or cytologically confirmed Stage IIB, Stage IIC, Stage III, or Stage IV melanoma (per American Joint Committee on Cancer, 8th edition) that was completely surgically resected. Complete surgical resection requires removal of all clinically or radiographically evident regional disease. Completion of lymph node dissection is not required unless clinically indicated. Participants must have been surgically rendered free of disease with negative margins on resected specimens documented by appropriate pathology and surgical reports.
  4. Complete surgical resection of melanoma must have been performed within 12 weeks before randomization.
  5. All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization.
  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  7. Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator.

Exclusion Criteria:

  1. History of ocular/uveal melanoma.

  2. Participants with an active, known, or suspected autoimmune disease are to be excluded from participation. Participants who have received systemic treatment for an autoimmune disease within the past 2 years before randomization (eg, with disease-modifying agents, corticosteroids, or immunosuppressive drugs) are also excluded.

  3. History of active malignancy other than melanoma under study within 3 years before randomization, except for locally curable early-stage cancers (carcinoma in situ or Stage I) that have been curatively treated, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

  4. Participants with a condition requiring systemic treatment with either corticosteroids >10 mg daily prednisone or equivalent or other immunosuppressive medications within 14 days before randomization. Inhaled or topical steroids, and adrenal replacement steroid doses <=10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease

  5. Female participants who are pregnant or breastfeeding at the screening visit, or who intend to become pregnant or breastfeed at any time during the study and for 150 days after the last dose of study intervention.

  6. Use of an investigational agent or an investigational device within 28 days or 5 half-lives (if half-life is known for the investigational agent), whichever is longer, before randomization or have not recovered from AEs associated with such therapies to Grade 1 or below (based on CTCAE Version 6.0).

  7. Any antineoplastic therapy after the complete resection of melanoma under study (eg, chemotherapy, radiation therapy, targeted agents, biotherapy, or limb perfusion).

  8. Participants who have received a live/attenuated vaccine within 28 days before randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine.

  9. Expected to receive any other form of antineoplastic therapy during the clinical study.

  10. Participants who received previous systemic therapy with any of the following: anti-programmed cell death-protein 1 (PD-1), anti programmed cell death-ligand 1 (PD-L1), anti-programmed cell death-ligand 2 (PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies (including nivolumab or pembrolizumab or ipilimumab or other CTLA-4 targeting agents), chimeric antigen receptor T-cell therapy cells, or any agents targeting the IL-2 pathway or other T-cell co-stimulation/ checkpoint pathways.

  11. Treatment with complementary medications (eg, herbal supplements or traditional medicines) with an antineoplastic intent to treat the melanoma within 2 weeks before randomization. Such medications are permitted if they are used as supportive care.

  12. Participants will be excluded if clinical assessment or laboratory investigations before randomization demonstrate any of the following:

    1. White blood cells: less than (<) 2000 per microliter

    2. Neutrophils: <1500 per microliter

    3. Platelets: <100 *103 per microliter

    4. Hemoglobin: <9.0 gram per deciliter (g/dL)

    5. Participants with estimated creatinine clearance (CrCl) (measured or calculated) less than or equal to (<=) 40 milliliter per minute (mL/min).

      • CrCl: using the Cockroft-Gault formula:

      • Female CrCl = [(140 - age in years) * weight in kilogram (kg) * 0.85] divided by (72 * serum creatinine in milligram per deciliter [mg/dL])
      • Male CrCl = [(140 - age in years) * weight in kg * 1.00] divide by (72 * serum creatinine in mg/dL)

    6. Aspartate aminotransferase: greater than (>) 2.5 * upper limit of normal (ULN)

    7. Alanine aminotransferase: >2.5 * ULN

    8. Total bilirubin >1.5 * ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of <3.0 * ULN)

  13. Participants positive for human immune deficiency virus (HIV-1 and HIV-2) tests. Screening for HIV infection must adhere to local regulatory guidelines and confirm the absence of HIV-1 and HIV-2 infection.

    Note: Participants with documented HIV infection may be enrolled where required by local regulatory or ethics committee guidance, provided all the following criteria are met:

    • The participant is on stable antiretroviral therapy for at least 12 weeks prior to the first dose of study treatment, and no planned change in antiretroviral therapy regimen during the PK sampling period.
    • Adequate immune function, defined as: CD4+ T cell count greater than or equal to (>=) 350 cells per millimeter cube (cells/mm^3) at screening
    • No history of uncontrolled or recent Acquired Immunodeficiency Syndrome (AIDS) defining illness, that is [ie], no active AIDS defining condition within the past 12 months
    • Undetectable viral RNA load

  14. Participants having positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, eg, hepatitis B surface antigen (Australia antigen) positive, or hepatitis C antibody (anti- HCV) positive (except if HCV RNA negative).

  15. Participants with history or current evidence of any clinically significant medical condition (including but not limited to physical examination, vital signs, electrocardiogram [ECG] findings, laboratory results), or ongoing therapy, that could confound study results, increase participation risk, or are deemed not in the participant's best interest by the treating investigator.

  16. Known history of allergy or hypersensitivity to IMP components.

  17. Known history of severe hypersensitivity reaction (Grade >=3) to any monoclonal antibody.

  18. Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

  19. Has documented or known current alcohol/drug abuse that precludes the participant's ability to adhere to the protocol.

  20. Prisoners or participants who are involuntarily incarcerated.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Bmab1700

Participants will receive intravenous infusion of Bmab1700 every 4 weeks (Q4W) in DB-TP until disease relapse or recurrence, unacceptable toxicity, or Week 20, whichever occurs earlier. At Week 24, after completing all pre-dose assessments, participants who will remain on study will continue to receive Bmab1700 Q4W until Week 48 end of treatment of OL-TP [EOT-OL-TP].
药品：Bmab1700

Intravenous infusion.
实验性的：Opdivo

Participants will receive intravenous infusion of Opdivo Q4W until disease relapse or recurrence, unacceptable toxicity, or Week 20, whichever occurs earlier. At Week 24, after completing all pre-dose assessments, participants who will remain on study will receive Bmab1700 Q4W until Week 48 end of treatment of OL-TP [EOT-OL-TP].
药品：Opdivo

Intravenous infusion.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Bmab 1700与Opdivo首次给药后第0天（第1天）至第29天的浓度-时间曲线下面积（AUC0-28天）
大体时间：第0周至第4周
第0周至第4周
Bmab 1700 和 Opdivo 的给药间隔内浓度-时间曲线下面积 (AUC0-tau)
大体时间：第16周至第20周
第16周至第20周

次要结果测量

结果测量
大体时间
Bmab 1700 与 Opdivo 的最大观察血清浓度 (Cmax)
大体时间：周期1，第1至22天：输注结束后给药前、1、3、24、48、168、336和504小时（每个周期为28天）
周期1，第1至22天：输注结束后给药前、1、3、24、48、168、336和504小时（每个周期为28天）
Bmab 1700 和 Opdivo 达到最大血清浓度的时间（Tmax）
大体时间：第1周期，第1至22天：输注结束前，以及输注结束后1、3、24、48、168、336和504小时（每个周期为28天）
第1周期，第1至22天：输注结束前，以及输注结束后1、3、24、48、168、336和504小时（每个周期为28天）
稳态下Bmab 1700与Opdivo的最大观察血浆浓度（Cmaxss）
大体时间：第5周期，第1至22天：输注结束前、输注结束后1、3、24、48、168、336和504小时（每个周期为28天）
第5周期，第1至22天：输注结束前、输注结束后1、3、24、48、168、336和504小时（每个周期为28天）
Bmab 1700 与 Opdivo 在稳态下达到最大血清浓度的时间 (Tmaxss)
大体时间：第5周期，第1至22天：输注结束后0小时（输注前）、1小时、3小时、24小时、48小时、168小时、336小时和504小时（每个周期为28天）
第5周期，第1至22天：输注结束后0小时（输注前）、1小时、3小时、24小时、48小时、168小时、336小时和504小时（每个周期为28天）
Bmab 1700 和 Opdivo 下次给药前血清观察浓度（Ctrough）
大体时间：第2至7周期，第1天：给药前（每个周期为28天）
第2至7周期，第1天：给药前（每个周期为28天）
发生不良事件（AEs）、严重不良事件（SAEs）及特别关注不良事件（AESIs）的参与者人数
大体时间：基线至第24周
基线至第24周
产生抗药抗体（ADA）且对Bmab 1700和Opdivo具有ADA效价的受试者百分比
大体时间：基线至第24周
基线至第24周

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Biocon Biologics UK PLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月9日

初级完成 (估计的)

2027年8月16日

研究完成 (估计的)

2028年2月16日

研究注册日期

首次提交

2026年3月12日

首先提交符合 QC 标准的

2026年3月12日

首次发布 (实际的)

2026年3月17日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BIO-NIVOLU-103
  • 2025-525158-20-00 (克蒂斯)
  • 2025 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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