ISRCTN10511385进行中（未招募）2 期
Efficacy and safety of first line Cemiplimab in advanced BCC: A phase 2 trial (IMPACT)
niversity Hospitals Bristol and Weston NHS Foundation Trust0 个研究点目标入组 41 人开始时间: 2023年6月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
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
- 性别
- All
入选标准
- •1. Men and women age = 18 years
- •2. ECOG performance status 0 or 1
- •3. Histologically confirmed disease (from diagnostic biopsy) that is considered to be inappropriate for surgery in the opinion of a SS-MDT
- •4. Patients must be deemed as not appropriate for radiotherapy in the opinion of a SS-MDT
- •5. There must be at least 1 measurable baseline lesion.
- •6. Adequate hepatic, renal and bone marrow function
- •7. Anticipated life expectancy >12 weeks
排除标准
- •1. Patients with metastatic BCC or Gorlins syndrome are excluded
- •2. History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs
- •3. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab.
- •4. Active infection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV).
- •5. History of pneumonitis within the last 5 years
- •6. Treatment with systemic immunostimulatory agents (including, but not limited to, IFNs, IL-2) within 28 days or 5 half-lives of the drug, whichever is shorter, prior to treatment start (Cycle 1 Day 1).
- •7. Treatment with PI3K inhibitors
- •8. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
- •9. Any anticancer treatment within 30 days of the initial administration of cemiplimab or planned to occur during the study period other than palliative radiotherapy.
- •10. Breastfeeding
- •11. Positive serum pregnancy test.
- •12. Women of childbearing potential (WOCBP), or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose.
- •13. Receipt of live vaccines (including attenuated) within 30 days of first study treatment.
- •14. Any acute or chronic psychiatric problems that, in the opinion of the investigator, make the patient ineligible for participation.
- •15. History of an additional malignancy within 5 years of registration with the exception of those malignancies with a negligible risk of metastasis or death and treated with curative intent.
- •16. Other concurrent serious illness or medical condition that in the investigator’s opinion precludes entry into the trial.
- •17. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- •18. Prior treatment with other systemic immune-modulating agents within fewer than 28 days prior to the first dose of cemiplimab.
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