Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

Обзор

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

Вмешательства

• Препарат Early discontinuation of Pembrolizumab with or without Bevacizumab
  1. Keytruda, (L01XC18), pembrolizumab, intravenous administration (administered as standard of care). 2. Avastin, (L01FG01), bevacizumab, intravenous administration (administered as standard of care).

Первичные конечные точки

• Evaluate the progression-free survival (PFS) and compare to the KEYNOTE-826 trial [Срок оценки: 12 months; for all patients]

Вторичные конечные точки (8)

• Evaluate progression-free survival (PFS) at 12- and 24 months [Срок оценки: 12 and 24 months; for all patients]
• To evaluate Overall Survival (OS) [Срок оценки: From enrollment till the end of survival follow-up of ten years or death. Median OS is estimated to be available at the half of total inclusion period (1,5 of 3 years) + median OS from registration trial, so expected at 56 months from trial start]
• Evaluate objective response rate (ORR) [Срок оценки: The ORR will be evaluated if all patients have had all response evaluations, this will be estimated at around 5 years (3 year inclusion + 2 year follow-up) after start of study.]
• Evaluate duration of response (DoR) [Срок оценки: from enrollement till disease progression, follow-up or death assesed up to about 48 months since commencement of treatment.]
• To describe the percentage of patients that develop immune-related endocrinopathies [Срок оценки: from commencement of treatment to the end of regular follow-up (+/- 48 months) or disease progression.]
• To evaluate the treatment related Immune-Related (Serious) Adverse Events (ir(S)AEs) which led to discontinuation or interruption of systemic treatment. [Срок оценки: from commencement of treatment to the end of regular follow-up (+/- 48 months) or disease progression.]
• The Health-Related Quality of Life in patients with recurrent, persistent or metastatic cervical cancer treated with a pembrolizumab-containing regimen [Срок оценки: from enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.]
• The anxiety and depression symptoms in patients with recurrent, persistent or metastatic cervical cancer treated with a pembrolizumab-containing regimen [Срок оценки: From enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.]

Критерии участия

Inclusion criteria 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)

Exclusion criteria 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 11 центров

• Amsterdam UMC — Amsterdam
• Antoni van Leeuwenhoek Ziekenhuis — Amsterdam
• Catharina Ziekenhuis — Eindhoven
• Medisch Spectrum Twente — Enschede
• University Mecdical Center Groningen — Groningen
• LUMC — Leiden
• Maastricht UMC — Maastricht
• Radboud UMC — Nijmegen
• … и ещё 3 центра

Идентификаторы

NCT: NCT07645625 · 22590

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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