EUCTR2016-002236-32-GB进行中（未招募）1 期
An Open-label, Multi-Center, Rollover Study in Patients with Advanced Melanoma After Completing an IMCgp100 Clinical Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
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
入选标准
- •Patients eligible for inclusion in this study must meet all of the following criteria:
- •1. Patient is currently participating in an Immunocore-sponsored study of IMCgp100 and is actively receiving IMCgp100. Patient must have fulfilled all required assessments in the parent study (unless the study is being terminated)
- •2. Patient is currently receiving clinical benefit from the treatment with IMCgp100, as determined by the principal investigator from the parent study
- •3. Patient has demonstrated compliance with the parent study requirements, as assessed by the principal investigator and patient is able to comply with the necessary visits and assessments as part of the rollover study
- •4. Written informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witness
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •Patients eligible for this study must not meet any of the following criteria:
- •1. Patient has been permanently discontinued from any IMCgp100 study or from IMCgp100 treatment in the parent study due to unequivocal progressive disease, unacceptable toxicity, noncompliance to study procedures, withdrawal of consent, or any other reason
- •2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test
- •3. Women of child-bearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using 2 methods of highly effective contraception from Screening, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods include barrier methods, intrauterine devices or hormonal methods. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Women of child-bearing potential must have a negative serum pregnancy test at Screening. Otherwise,
- •female patients must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile
- •4. Male patients who are not surgically sterile unless they are using a double barrier contraception method from enrollment through treatment and for 6 months following administration of the last dose of study drug
研究者
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