2025-525093-11-00招募中3 期
A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants with Stage IIB/C-III Melanoma Following Complete Resection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 16
- 主要终点
- Area under the concentration-time curve from time 0 to 3 weeks (AUC0-3w) (Cycle 1)
研究概览
简要总结
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma (as classified by the American Joint Committee on Cancer’s Cancer Staging Manual, 8th Edition) who have undergone complete resection with negative surgical margins. No evidence of past or current satellites or in-transit metastases.
- •Disease status for the post-surgery baseline assessment must be documented by full chest/abdomen/pelvis computed tomography (CT) or magnetic resonance imaging (MRI) with neck CT and/or MRI (for head and neck primaries) and by a complete a clinical examination after the informed consent form (ICF) has been signed and before enrollment.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.
- •Participants (male/female) ≥18 years of age at the time of signing the ICF.
排除标准
- •Prior active malignancy within the previous 3 years except for locally curable cancers that undergone potentially curative therapy, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- •Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed >5 years ago.
- •Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).
- •Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- •Has received prior systemic anticancer therapy for melanoma including investigational agents.
研究组 & 干预措施
Pembrolizumab
Test
干预措施: Pembrolizumab (Drug)
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Comparator
干预措施: KEYTRUDA 25 mg/mL concentrate for solution for infusion. (Drug)
结局指标
主要结局
Area under the concentration-time curve from time 0 to 3 weeks (AUC0-3w) (Cycle 1)
Area under the concentration-time curve from time 0 to 3 weeks (AUC0-3w) (Cycle 1)
Area under the concentration-time curve over the dosing interval at steady-state (AUCtau) (Cycle 6)
Area under the concentration-time curve over the dosing interval at steady-state (AUCtau) (Cycle 6)
次要结局
- PK: Maximum concentration after the first dose (Cmax,0-3w) (Cycle 1) and at steady-state (Cmax,tau) (Cycle 6)
- PK: Observed concentration before the next dose during multiple dosing cycles (Ctrough)
- PK: Time to maximum concentration after the first dose (Tmax,0-3w) (Cycle 1) and at steady-state (Tmax,tau) (Cycle 6)
- PK: Apparent clearance after the first dose (CL0-3w) (Cycle 1) and at steady-state (CLtau) (Cycle 6)
- PK: Terminal elimination half-life (t½) (Cycle 1 and Cycle 6)
- PK: Apparent volume of distribution after the first dose (Vz0-3w) (Cycle 1) and at steady-state (Vztau) (Cycle 6)
- Efficacy: Recurrence-free survival (RFS) assessed up to Week 51
- Safety: Adverse events (AEs): incidence, nature (ie, description of the event), and severity including treatment-related AEs, serious adverse events, and adverse events of special interest, graded according to Common Terminology Criteria for Adverse Events grading
- Safety: Absolute values and changes from baseline in: o Clinical laboratory assessments: hematology, biochemistry, and thyroid hormones o Vital signs o 12-lead electrocardiograms (ECGs) o Physical examination findings
- Immunogenicity: Incidence and titer of anti-drug antibodies (ADAs) against AVT32-DRL_PB and Keytruda
- Immunogenicity: Incidence of neutralizing antibodies (nAbs)
研究者
Felicitas Bullo
Scientific
Alvotech Swiss AG
研究点 (16)
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