CTRI/2026/02/103512尚未招募1 期
A randomized, double-blind, parallel-group study to compare pharmacokinetics of JPB898(proposed nivolumab biosimilar) and US-licensed Opdivo in participants with resected stage IIB, IIC, or III melanoma requiring adjuvant treatment with nivolumab.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Hexal AG
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- To demonstrate PK similarity between JPB898 and Opdivo-US – test formulation and Opdivo-US - reference product in participants with resected stage IIB, IIC, or III melanoma requiring adjuvant treatment with nivolumab
研究概览
简要总结
This study aims to demonstrate PK similarity between the proposed nivolumab biosimilar JPB898 and the US-licensed reference product Opdivo administered in participants with resected stage IIB, IIC, or III melanoma in the adjuvant setting. The safety and immunogenicity profiles of JPB898 and Opdivo-US will be descriptively compared and evaluated up to the primary analysis at Week 17. After the primary analysis, only safety data will be evaluated in the open-label treatment period until the end of the study duration.
The maximum study duration for a participant will be approximately 57 weeks, including 4 weeks screening, 16 weeks in Treatment Period1, and 36 weeks (±7 days visit window for Week 53/EoS) in Treatment Period2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed informed consent obtained before participation in the study.
- •Male or female participants greater than or equal to 18 years of age or of age of legal majority, whichever is higher, on day of signing informed consent.
- •Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- •Histologically confirmed melanoma.
- •Completely surgically resected (including sentinel lymph node if applicable), stage IIB, IIC, or III cutaneous melanoma, classified per AJCC 8th edition with pathology reports confirming negative margins on the resected specimens (per local standard).
- •Disease-free status (no loco-regional relapse or distant metastasis, no clinical evidence for brain metastases) as supported by a complete physical examination and post-surgical tumor imaging (within 28 days prior to first study treatment).
- •Minimum 2 to maximum 12 weeks from final surgical resection or sentinel lymph node biopsy to first study treatment with adequate wound healing (as per the Investigator’s judgement) from the surgery
- •If radiotherapy was indicated after lymph node dissection, completed before first study treatment
- •Adverse effects resulting from prior radiotherapy or other antineoplastic therapy must have resolved to CTCAE grade 1 (or lower).
- •Participant has recovered adequately from toxicity and/or complications from surgery prior to study start 11.
排除标准
- •Known history or evidence of uveal or ocular melanoma at time of screening.
- •Prior active non-melanoma malignancy within the previous 1 year that has not been treated or that still requires any concomitant systemic therapy (except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
- •Active autoimmune disease that has required chronic systemic treatment in the past 12 weeks. -Participants with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted.
- •Participants with a condition requiring systemic treatment with either corticosteroids (greater than equal to 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD37, anti-CTLA-4, anti-LAG-3, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- •Abnormal safety laboratory results at screening or baseline. WBC less than 2000 per microlitre Neutrophils less than 1500 per microlitre Platelets less than 100 × 103 per microlitre Haemoglobin less than 9.0 gram per decilitre Serum creatinine greater than 1.5 times ULN However, if creatinine clearance greater than or equal to 40 mL per min.
- •calculated using the Cockcroft Gault formula below, then the participant is eligible: Female CrCl = (
- •age in years) x weight in kg 0.85 / 72 x serum creatinine in mg/dL Male CrCl = (
- •age in years) weight in kg x 1.00 / 72 x serum creatinine in mg/dL AST greater than 3.0 times ULN ALT greater than 3.0 times ULN Total bilirubin greater than 1.5 times ULN (participants with Gilbert Syndrome: greater than or equal to 3.0 times ULN).
- •Participants with history of or active pneumonitis/interstitial lung disease, and history of allogeneic transplant(organ or bone marrow).
- •Inadequate recovery from any major surgery (with ongoing toxicity or other complications) at time of screening.
- •Known history of hypersensitivity to the active components and excipients of the study treatment.
- •Known history or current diagnosis of clinically significant cardiac abnormalities that may increase the risk associated with study participation.
- •Known history of a medical condition or an underlying advanced, severe and uncontrolled condition which in the opinion of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product, or that might affect participant safety or interpretation of the study results.
- •Known history or current diagnosis of HIV (i.e. HIV 1/2 antibodies positive).
- •Active Hepatitis B or Hepatitis C(e.g. HBsAg positive or HBcAb positive and subsequently quantitative HBV DNA PCR positive) or Hepatitis C (i.e. HCV Ab positive and subsequently quantitative HCV RNA results greater than the lower limits of detection of the assay).
- •Known alcohol, drug, or substance abuse within 12 months prior to first study treatment.
- •Use of other investigational drugs at the time of screening, or within 5 half-lives of the other investigational drug before first study treatment, or within 3 months, whichever is longer.
- •Pregnant (confirmed by serum pregnancy test) or breastfeeding women
- •Legally institutionalized, or those under judicial protection
- •Immediate family member (i.e., spouse, parent/legal guardian, sibling, or a child) being a member of study site staff or being a member of the Sponsor’s study team.
- •Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unwilling to use highly effective methods of contraception while taking study treatment and for 5 months after stopping study treatment.
- •Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 5 months after stopping study treatment.
结局指标
主要结局
To demonstrate PK similarity between JPB898 and Opdivo-US – test formulation and Opdivo-US - reference product in participants with resected stage IIB, IIC, or III melanoma requiring adjuvant treatment with nivolumab
时间窗: A total of 15 PK samples will be collected including pre-dose blood sample on C1D1, C2D1, C3D1, C4D1, C5D1; and post dose blood samples at 0.75 h, 4 h on day 1 and at 24h on day 2 at 168 h on day 8 and 504 h on day 22 after Cycle 1 and Cycle 4
次要结局
- To descriptively compare PK, Safety, Immunogenicity of test and reference products(Timepoint:)
研究者
Dr Rakesh Patel
Veeda Clinical research Limited
研究点 (16)
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