A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 100
- 试验地点
- 132
- 主要终点
- Type, incidence and severity of ocular adverse events (AEs)
研究概览
简要总结
TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease.
- This study is seeking for participants who: Are willing to take all the required eye tests
- Have not received TIVDAK before
- Do not have any active eye issues.
Participants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages:
- before starting the treatment,
- before each of the first 9 infusions
- then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
- •Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information
- •Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate
- •Must be willing to undergo repeated ocular assessments as required by the study and regular clinic visits according to local standard practice of the study site
- •Must agree to use effective contraception according to the US Prescribing Information
排除标准
- •Active ocular disease at baseline per investigator assessment
- •Previous treatment with Tivdak
- •Previous administration of an investigational drug within 30 days
- •Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator'
研究组 & 干预措施
Tisotumab vedotin
Participants will receive tisotumab vedotin by IV infusion.
干预措施: TIVDAK (Drug)
结局指标
主要结局
Type, incidence and severity of ocular adverse events (AEs)
时间窗: 90 days after the last dose of tisotumab vedotin
次要结局
- Incidence of serious adverse events (SAEs)(90 days after the last dose of tisotumab vedotin)
- Time to resolution of ocular AEs(90 days after the last dose of tisotumab vedotin)
- Time to onset of ocular AEs(90 days after the last dose of tisotumab vedotin)
- AEs leading to dose modifications including treatment discontinuation(90 days after the last dose of tisotumab vedotin)