Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This nationwide, multicenter registry prospectively tracks outcomes for patients receiving pembrolizumab-based therapy in real-world settings. It includes an observation cohort continuing treatment per standard of care and an early-discontinuation cohort for patients stopping pembrolizumab (with or without bevacizumab) for reasons such as sustained response, toxicity, or personal choice. Follow-up extends up to two years per patient, with survival data collected for up to 10 years. The study aims to understand real-world effectiveness, safety, and treatment patterns beyond controlled trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Catharina Ziekenhuis
  Eindhoven, Netherlands Recruiting
• University Mecdical Center Groningen
  Groningen, Netherlands Recruiting
• Lumc
  Leiden, Netherlands Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Not yet recruiting
• Antoni van Leeuwenhoek Ziekenhuis
  Amsterdam, Netherlands Not yet recruiting
• Medisch Spectrum Twente
  Enschede, Netherlands Not yet recruiting

Study contacts

• Principal investigator: M. Jalving — University Medical Center Groningen
• Study coordinator: M. Jalving, MD, PhD
• Email: m.jalving@umcg.nl
• Phone: +31 50 361 2821

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.