CTIS2023-503519-13-00招募中1 期
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Hepatocellular Carcinoma who are Naive to IO Therapy but Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073) - CA224-073
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 250
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
- •Male and female participants must be = 18 years at the time of informed consent., - Participants with histologic confirmed advanced/metastatic 2L or 3L HCC., - Participants with pre-treatment tumor tissue sample with evaluable LAG-3 expression level by IHC. Participants with indeterminate or unevaluable LAG-3 status results will not be permitted to receive study treatment or randomize to a treatment arm., - Participants who have experienced progression that was demonstrated radiographically on or after one or two prior TKI therapies without prior exposure to IO agents., - Child-Pugh score of 5 or 6 points (ie, Child-Pugh A)., - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •- Women who are pregnant or breastfeeding, - Untreated symptomatic central nervous system metastases or leptomeningeal metastases., - Participants with uncontrolled or significant cardiovascular disease., - Prior organ allograft or allogeneic bone marrow transplantation., - Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll., - Participants with symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
研究者
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