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NCT Number: NCT07645625

Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

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

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Amsterdam UMC, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early discontinuation of Pembrolizumab with or without Bevacizumab

Drug
  • Keytruda, (L01XC18), pembrolizumab, intravenous administration (administered as standard of care).
  • Avastin, (L01FG01), bevacizumab, intravenous administration (administered as standard of care).

Primary outcomes

  1. Evaluate the progression-free survival (PFS) and compare to the KEYNOTE-826 trial

    Time frame: 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.

Secondary outcomes

  1. Evaluate progression-free survival (PFS) at 12- and 24 months

    Time frame: 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.

  2. To evaluate Overall Survival (OS)

    Time frame: 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%.

  3. Evaluate objective response rate (ORR)

    Time frame: 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.

  4. Evaluate duration of response (DoR)

    Time frame: 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.

  5. To describe the percentage of patients that develop immune-related endocrinopathies

    Time frame: 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).

  6. To evaluate the treatment related Immune-Related (Serious) Adverse Events (ir(S)AEs) which led to discontinuation or interruption of systemic treatment.

    Time frame: 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).

  7. The Health-Related Quality of Life in patients with recurrent, persistent or metastatic cervical cancer treated with a pembrolizumab-containing regimen

    Time frame: 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

  8. The anxiety and depression symptoms in patients with recurrent, persistent or metastatic cervical cancer treated with a pembrolizumab-containing regimen

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

G. M.M. Lenis, MD

CONTACT

[email protected]

+31 50 361 6161

M. Jalving, MD, PhD

CONTACT

[email protected]

+31 50 361 2821

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: PROTECx

Important dates

Study start
2026
Primary completion
2030
Study completion
2039
First posted
Jun 12, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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