An Open-label, Multi-center, Rollover Study in Patients With Advanced Melanoma After Completing an IMCgp100 Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events
研究概览
简要总结
IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for eligible participants with advanced melanoma who have previously participated in an IMCgp100 study (parent study).
详细描述
IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for eligible participants with advanced melanoma who have previously participated in an IMCgp100 study (parent study). Parent studies that are eligible for participants to continue to receive IMCgp100 in this rollover study must have completed and satisfied its primary endpoints or have been terminated by the Sponsor for reasons other than safety.
Eligible participants will have tolerated IMCgp100 for a minimum of 4 weeks of dosing without significant toxicities that would preclude further dosing in the opinion of the principal investigator or Sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is currently participating in an Immunocore-sponsored study of IMCgp100 and is actively receiving IMCgp
- •Participant must have fulfilled all required assessments in the parent study (unless the study is being terminated)
- •Participant is currently receiving clinical benefit from the treatment with IMCgp100, as determined by the principal investigator from the parent study
- •Participant has demonstrated compliance with the parent study requirements, as assessed by the principal investigator and participant is able to comply with the necessary visits and assessments as part of the rollover study
- •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
排除标准
- •Participant has been permanently discontinued from any IMCgp100 study or from IMCgp100 treatment in the parent study due to unequivocal progressive disease, unacceptable toxicity, non-compliance to study procedures, withdrawal of consent, or any other reason
- •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
- •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 participants must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile
- •Male participants 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
研究组 & 干预措施
Regimen 1
IMCgp100 (77 kDa bi-specific protein) weekly dosing regimen (QW)
干预措施: IMCgp100 (Drug)
结局指标
主要结局
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events
时间窗: Up to 2 years and 4 months
Incidence of adverse events was presented as the number of participants with treatment-emergent adverse events (TEAEs). TEAEs were defined as adverse events (AEs) that started or worsened in severity from the date of first dose of the rollover study (regardless of time) up until 90 days after the last dose of study drug of this rollover study. Participants with multiple events in the same category were counted only once in that category. Participants with events in more than 1 category were counted once in each of those categories. TEAEs indicated considered related to IMCgp100 were determined by the investigator to be possibly related or related to study drug.
次要结局
- Tolerability: Dose Reductions by Participant - Relative Dose Intensity(Up to 2 years and 4 months)
- Tolerability: Dose Interruptions by Participant - Number of Cycles(Up to 2 years and 4 months)
- Assessments of Anti-IMCgp100 Antibody Formation: Number of Participants With Anti-IMCgp100 Antibody Formation(Up to 2 years and 4 months)
- Tolerability: Dose Interruptions by Participant - Duration(Up to 2 years and 4 months)
- Tolerability: Dose Reductions by Participant - Actual Total Dose Received(Up to 2 years and 4 months)
- Tolerability: Dose Reductions by Participant - Dose Intensity(Up to 2 years and 4 months)
- Overall Survival Status of All Participants Treated With IMCgp100: Number of Months(Up to 2 years and 4 months)