2024-517290-24-00
招募中
2 期
A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 6
- 主要终点
- Overall survival, date of death in relation to study randomization
概览
简要总结
The dual primary objectives are:
-
To compare the OS in all patients randomized to the tebentafusp monotherapy versus all patients randomized to the Investigator’s Choice monotherapy
-
To compare the OS in all patients randomized to the tebentafusp monotherapy who develop a rash within the first week of treatment versus all patients randomized to the Investigator’s Choice monotherapy
Both objectives relate to HLA-A*0201 positive patients with advanced UM with no prior treatment in the metastatic setting.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years of age or older
- •Ability to provide and understand written informed consent
- •Histologically or cytologically confirmed metastatic UM
- •Must meet the following criteria related to prior treatment: • No prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy • No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization • Prior surgical resection of oligometastatic disease is allowed • Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease.
- •HLA-A*0201 positive
- •Life expectancy of > 3 months
- •ECOG Performance Status of 0 or 1
- •Patients have measurable disease or non-measurable disease according to RECIST v1.1
- •All other relevant medical conditions must be well-managed and stable
排除标准
- •Patient with any out-of-range laboratory values defined as: • Serum creatinine > 1.5 × upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/minute • Total bilirubin > 1.5 × ULN, except for patients with Gilbert’s syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN • Alanine aminotransferase > 3 × ULN • Aspartate aminotransferase > 3 × ULN • Absolute neutrophil count < 1.0 × 109/L • Absolute lymphocyte count < 0.5 × 109/L • Platelet count < 75 × 109/L • Hemoglobin < 8 g/dL
- •Patients receiving systemic steroid therapy or any other systemic immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment.
- •History of adrenal insufficiency
- •History of interstitial lung disease
- •History of pneumonitis that required corticosteroid treatment or current pneumonitis
- •History of colitis or inflammatory bowel disease
- •Major surgery within 2 weeks of the first dose of study drug
- •Radiotherapy within 2 weeks of the first dose of study drug
- •Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug.
- •Pregnant, or lactating
结局指标
主要结局
Overall survival, date of death in relation to study randomization
Overall survival, date of death in relation to study randomization
次要结局
- Safety and tolerability: Incidence and severity of AEs and SAEs; changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF); dose interruptions, reductions, discontinuations, and dose intensity of all administered agents
- Serum PK parameters (eg, Cmax, Cmin, Ctrough)
- • PFS • BOR • DOR • Time to response DCR (defined as CR or PR, or SD ≥ 24 weeks)
- EQ-5D,5L and EORTC QLQ-C30 change from Baseline over time and between treatment strategies
- Assessments of anti-tebentafusp antibody formation
研究者
Regulatory Affairs
Scientific
Immunocore Limited
研究点 (6)
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