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Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer (PROTECx)

2026年6月24日 更新者：University Medical Center Groningen
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

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

261

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：M. Jalving, MD, PhD
  • 電話番号：+31 50 361 2821
  • メール：m.jalving@umcg.nl

研究連絡先のバックアップ

研究場所

  • オランダ
      • Amsterdam、オランダ
        • まだ募集していません
        • Amsterdam UMC
        • コンタクト：
        • 主任研究者：
          • J. Tromp
      • Amsterdam、オランダ
        • まだ募集していません
        • Antoni Van Leeuwenhoek Ziekenhuis
        • コンタクト：
        • 主任研究者：
          • M. A. Rijlaarsdam
      • Eindhoven、オランダ
      • Enschede、オランダ
        • まだ募集していません
        • Medisch Spectrum Twente
        • コンタクト：
        • 主任研究者：
          • A. N.M. Wymenga
      • Groningen、オランダ、9713 GZ
        • 募集
        • University Mecdical Center Groningen
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • M. Jalving, MD, PhD
      • Leiden、オランダ
        • 募集
        • LUMC
        • コンタクト：
        • 主任研究者：
          • J. R. Kroep
      • Maastricht、オランダ
        • まだ募集していません
        • Maastricht UMC
        • コンタクト：
        • 主任研究者：
          • A. J.M. Beijers
      • Nijmegen、オランダ
        • まだ募集していません
        • Radboud UMC
        • コンタクト：
        • 主任研究者：
          • V. Soomers
      • Rotterdam、オランダ
        • まだ募集していません
        • Erasmus MC
        • コンタクト：
        • 主任研究者：
          • I. A. Boere
      • Utrecht、オランダ
        • まだ募集していません
        • UMC Utrecht
        • コンタクト：
        • 主任研究者：
          • I. O. Baas
      • Zwolle、オランダ
        • まだ募集していません
        • Isala Klinieken
        • コンタクト：
        • 主任研究者：
          • W. A. van der Steeg

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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:

    1. 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
    2. Immune-related toxicity grade ≥ 3 OR
    3. Patient's preference (e.g. chronic or invalidating grade 1-2 immune-related toxicity) OR
    4. 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
介入なし：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.
実験的：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.
薬：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).

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Evaluate the progression-free survival (PFS) and compare to the KEYNOTE-826 trial
時間枠：12 months; for all patients

To evaluate the progression PFS at 12 months and compare it to the historical PFS at 12 months of the KEYNOTE-826 trial.

PFS is defined as the time from start of first line treatment to the first documented disease progression or death due to any cause, whichever occurs first.
12 months; for all patients

二次結果の測定

結果測定
メジャーの説明
時間枠
Evaluate progression-free survival (PFS) at 12- and 24 months
時間枠：12 and 24 months; for all patients

To evaluate the PFS at 12- and 24 months for the complete cohort; the observation cohort and the discontinuation cohort separately and per the different response outcomes (SD/PR/CR).

PFS is defined as the time from start of first line treatment to the first documented disease progression or death due to any cause, whichever occurs first.
12 and 24 months; for all patients
To evaluate Overall Survival (OS)
時間枠：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

To evaluate the OS, OS is defined as: the time from start of first line treatment to death due to any cause.

Survival curves will be plotted, the OS rate at different time points will be estimated using the Kaplan-Meier method and the median OS wil be evaluated.

Survival follow-up is for up to ten years after commencement of treatment. To give an indication: median OS in the KEYNOTE-826 trial for CPS≥1 (trial population) cohort was 28.6 months and 24-months OS 53.5%.
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)
時間枠：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.

To evaluate the ORR, ORR is defined as the proportion of patients with CR and PR.

Response for the individual patient will be measured/assessed every 12-18 (±1) weeks starting from baseline till two years of treatment, progression or death.
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)
時間枠：from enrollement till disease progression, follow-up or death assesed up to about 48 months since commencement of treatment.
To evaluate the DoR, which is defined as the time from the first documented evidence of CR or PR until the first documented disease progression or death due to any cause, whichever occurs assesed up to about 48 months since commencement of treatment.
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
時間枠：from commencement of treatment to the end of regular follow-up (+/- 48 months) or disease progression.

The percentage of patients that develop immune-related endocrinopathies

Ir(S)AEs are collected until end of standard follow-up (2 years or disease progression).
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.
時間枠：from commencement of treatment to the end of regular follow-up (+/- 48 months) or disease progression.

To describe the percentage of patients which irAEs led to discontinuation or interruption (≥12 weeks) of treatment during (rechallenge of) PD-1 blockade.

Ir(S)AEs are collected until end of standard follow-up (2 years or disease progression).
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
時間枠：from enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.
The European Organisation For Research And Treatment Of Cancer (EORTC) QLQ-C30. The tool is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, a high score for a symptom scale/item represents a high level of symptomatology/problems
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
時間枠：From enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.
Hospital Anxiety and Depression Scale (HADS) is designed to assess symptoms of anxiety and depression in clinical and research settings. It consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D), each containing seven items scored on a 4-point Likert scale. Scores from 0-21 for each subscale, higher scores means greater distress.
From enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University Medical Center Groningen

捜査官

  • 主任研究者：M. Jalving、University Medical Center Groningen

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月11日

一次修了 (推定)

2030年5月1日

研究の完了 (推定)

2039年2月1日

試験登録日

最初に提出

2026年1月5日

QC基準を満たした最初の提出物

2026年6月11日

最初の投稿 (実際)

2026年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月29日

QC基準を満たした最後の更新が送信されました

2026年6月24日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 22590

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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