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
试验速览
- 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
研究概览
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
- •Women of childbearing potential, unless they are using highly effective contraception during study treatment.
- •History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
- •Male patients must be surgically sterile or use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study drug
- •Patients who are in an institution due to official or judicial order
- •Patients who are related to the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in the conduct of the study
- •Contraindication for treatment with Investigator’s Choice alternatives (dacarbazine, ipilimumab and pembrolizumab) as per applicable labelling.
- •Clinically significant cardiac disease or impaired cardiac function, including any of the following: • Clinically significant and/or uncontrolled heart disease such as congestive heart failure, uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment • QTcF > 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome. • Acute myocardial infarction or unstable angina pectoris
- •Presence of symptomatic or untreated central nervous system (CNS) metastases,
- •Active infection requiring systemic antibiotic therapy.
- •Known history of human immunodeficiency virus infection (HIV).
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol.
- •Malignant disease, other than that being treated in this study.
- •Any medical condition that would, in the investigator’s or Sponsor’s judgment, prevent the patient’s participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results
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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