CTIS2023-505306-42-01招募中1 期
A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301) - IMC-F106C-301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 812
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participants must be = 18 years of age, Participant must have a life expectancy of at least 3 months., Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention, Participants must be capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol, Participants must agree to provide all necessary samples for biomarker analysis., Participants must be HLA-A*02:01-positive, Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma, Archived or fresh tumor tissue sample that must be confirmed as adequate, Participants must have measurable disease per RECIST 1.1, Participant must have BRAF V600 mutation status determined, Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
排除标准
- •Participants with a history of a malignant disease other than those being treated in this study, Participants with clinically significant cardiac disease or impaired cardiac function, Participants with active autoimmune disease requiring immunosuppressive treatment, Participants with any medical condition that is poorly controlled or that would, in the Investigator’s or Sponsor’s judgment, adversely impact the participant’s participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results., Participants for whom, in the Investigator's judgement, the benefit/risk favors combination therapy with nivolumab/ipilimumab, Participants with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study., Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma, Participants with activating BRAF mutations with rapidly progressing tumours which pose an immediate threat to an important organ or its function, Participants who received prior treatment with any TCE bispecific therapy, including an ImmTAC molecule, or any cellular therapies (eg, adoptive cell therapy including TCR T-cell therapies)., Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3, Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis, Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients., Participants with clinically significant pulmonary disease or impaired lung function
研究者
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