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 - A clinical trial comparing the safety and activity of IMCgp100 to

IMMUNOCORE LTD0 个研究点入组 327 人开始时间: 2021年6月15日最近更新: 2021年8月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: IMMUNOCORE LTD
入组人数: 327

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

Male or female patients age = 18 years of age at the time of informed consent
Ability to provide and understand written informed consent prior to any study procedures
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 local, liver-directed therapy including chemotherapy, radiotherapy, radiofrequency ablation (RFA), or embolization
Prior surgical resection of oligometastatic liver disease is allowed
Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease. Patients may not be re-treated with Investigator's Choice therapy that was administered as adjuvant or neo-adjuvant treatment
HLA-A*0201 positive by central assay
Life expectancy of > 3 months as estimated by the investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening
Patients must have measurable disease according to RECIST v.1.1 criteria
All other relevant medical conditions must be well-managed and stable, in the opinion of the
investigator, for at least 28 days prior to first administration of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 129

排除标准

Pt with any out-of-range lab. values defined as:
Serum creatinine > 1.5 × upper limit of normal &/or creatinine clearance < 50 mL/min
Total bilirubin > 1.5 × ULN, except for pts 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 × 10^9/L
Absolute lymphocyte count < 0,5 x 10^9/L
Platelet count < 75 × 10^9/L
Hemoglobin < 8 g/dL
Potassium, magnesium, corr. calcium or phosphate abnormality of (v4.03) > grade 1
History of severe hypersensitivity reactions to other biologic drugs or monoclonal antibodies
Clinically significant cardiac disease or impaired cardiac funct., including any of the following:
Clinically significant &/or uncontrolled heart disease such as congestive heart failure, uncontrolled hypertension, or clinically significant arrhythmia currently req. medical treatment
QTcF > 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome
Acute myocardial infarction or unstable angina pectoris < 6 months prior to Screening
Presence of symptomatic or untreated central nervous system metastases, or CNS
metastases that require doses of corticosteroids within the prior 3 weeks to study D. 1.
Pts with brain metastases are eligible if lesions have been treated with localized
therapy and there is no evidence of PD for at least 4 weeks by MRI prior to the
first dose of study drug
Active infection requiring systemic antibiotic therapy. Pat. Requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug
Known history of human immunodeficiency virus infection. Testing for HIV status is not necessary unless clinically indicated
Active hepatitis B virus or hepatitis C virus infection per institutional prot.
Malignant disease, other than that being treated in this study.
Any medical condition that would, in the inv.'s or Sponsor's judgment, prevent the pt's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results
Pts 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. Local steroid therapies are acceptable
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, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass
Use of hematopoietic colony-stimulating growth factors = 2 weeks prior to start of study drug. 18.Pregnant, likely to become pregnant, or lactating women
Women of child-bearing potential who are sexually active
Male pts must be surgically sterile or use double barrier contraception methods.

研究者

发起方

IMMUNOCORE LTD

标识符

注册编号: EUCTR2015-003153-18-IT
其他研究编号: IMCgp100-202, ISRCTN12345678, NCT12345678, 2015-003153-18-DE

日期

最近更新: 2021年8月10日 (5年前)

监管与共享

是否有结果: 否

相似试验

进行中（未招募）

1 期

A clinical trial comparing the safety and activity of IMCgp100 to Investigator's Choice. This study will only take place in patients who have a particular type (HLA-A*0201) of the uveal melanoma (a cancer which started and then spread from the coloured cells of the eye).veal MelanomaMedDRA version: 21.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2015-003153-18-BEImmunocore Limited369

进行中（未招募）

1 期

EUCTR2015-003153-18-DEImmunocore Limited369

进行中（未招募）

1 期

EUCTR2015-003153-18-PLImmunocore Limited327

进行中（未招募）

1 期

A clinical trial comparing the safety and activity of IMCgp100 to Investigator's Choice. This study will only take place in patients who have a particular type (HLA-A*0201) of the uveal melanoma (a cancer which started and then spread from the coloured cells of the eye).veal MelanomaMedDRA version: 20.0Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2015-003153-18-ESImmunocore Limited327

进行中（未招募）

1 期

EUCTR2015-003153-18-NLImmunocore Limited369