CTIS2022-502123-21-00进行中（未招募）1 期
Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma - MK-6482-013
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 154
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
- •Has a histologically confirmed diagnosis of locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component, Can submit an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated, Has experienced disease progression on or after systemic treatment with an anti-programmed cell death 1 (PD-1)/Ligand 1 (L1) therapy for locally advanced or metastatic RCC, Has received no more than 3 prior systemic regimens for locally advanced or metastatic RCC, Has recovered from all AEs due to previous therapies to =Grade 1 or baseline, with the exception of =Grade 2 neuropathy or endocrine-related AEs =Grade 2 requiring treatment or hormone replacement
排除标准
- •Has hypoxia (a pulse oximeter reading <92% at rest), requires intermittent supplemental oxygen, or requires chronic supplemental oxygen, Has an active infection requiring systemic therapy, Has active tuberculosis (TB), Has a diagnosis of immunodeficiency, Has a known history of human immunodeficiency virus (HIV) infection, Has a known history of hepatitis B (HBV) or known active hepatitis C (HCV) infection, Has a known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy, Has known CNS metastases and/or carcinomatous meningitis, Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction =6 months from Day 1 of study drug administration or New York Heart Association Class III or IV congestive heart failure, Has moderate to severe hepatic impairment (Child-Pugh B or C), Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) =2 weeks before randomization, Has received any type of systemic anticancer antibody (including investigational antibody) =4 weeks before randomization, Has received prior radiotherapy =2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids, Has had major surgery =3 weeks prior to first dose of study intervention
研究者
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