Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 261
- 试验地点
- 11
研究概览
简要总结
This is a nationwide, multicenter, registry-based prospective cohort study to assess real-world effectiveness of treatment with a pembrolizumab containing regimen in persistent, recurrent, or metastatic cervical cancer. Patients in the observation cohort continue treatment according to standard of care. In the discontinuation cohort, patients discontinue their maintenance treatment with pembrolizumab (with or without discontinuation of bevacizumab). Patients may choose to discontinue pembrolizumab prematurely (with or without discontinuation of bevacizumab) if they achieve a confirmed CR or a confirmed PR to treatment, or on patient's request or due to toxicity. If an eligible patient chooses not to discontinue treatment early they will remain in the observation cohort. The duration of the trial for the individual patient will be until two years from the start of treatment. Survival follow-up will continue for a maximum of 10 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •for the observation cohort:
- •- Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.
- •Inclusion criteria for the early discontinuation cohort:
- •Previous inclusion in the observation cohort
- •Choice made to stop pembrolizumab for one of the following reasons:
- •Confirmed complete response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a CR (consistent with KEYNOTE-826 criteria) OR
- •Immune-related toxicity grade ≥ 3 OR
- •Patient's preference (e.g. chronic or invalidating grade 1-2 immune-related toxicity) OR
- •Confirmed partial response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a PR (timing consistent with KEYNOTE-826 criteria)
- •Eligible and willing to discontinue pembrolizumab (with or without discontinuing bevacizumab)
排除标准
- •for all cohorts are:
- •Malignant other disease other than cervical carcinoma that required active treatment in the past 2 years: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or any carcinoma in situ that have undergone potentially curative therapy are not excluded
- •Any psychological, familial, sociological or geographical condition or a known psychiatric or substance abuse disorder potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. This comprises each and every condition or circumstance preventing the patient from showing up to the outpatient controls and/or undergoing the CT-scans, or preventing the patient from (adequately) filling out the questionnaires.
研究组 & 干预措施
Observation cohort
The observation cohort will consist of all participants who receive standard of care treatment and are not eligible for the discontinuation cohort or do not wish to discontinue treatment. Patients will be asked to complete questionnaires every 12 weeks.
Discontinuation cohort
The discontinuation cohort will consist of participants who discontinue pembrolizumab (with or without discontinuation of bevacizumab) therapy early according to the inclusion criteria listed in the study protocol. Additionally, will be asked to complete questionnaires every 12 weeks.
干预措施: Early discontinuation of Pembrolizumab with or without Bevacizumab (Drug)