Clinical Trials in the Netherlands / NCT07645625
Recruiting Phase 4

Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

NCT07645625 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 4
Started
2026-05-11
Last updated
2026-06-29

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

Early discontinuation of Pembrolizumab with or without Bevacizumab

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).

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam Netherlands Not Yet Recruiting
Antoni van Leeuwenhoek Ziekenhuis Amsterdam Netherlands Not Yet Recruiting
Catharina Ziekenhuis Eindhoven Netherlands Recruiting
Medisch Spectrum Twente Enschede Netherlands Not Yet Recruiting
University Mecdical Center Groningen Groningen Netherlands Recruiting
LUMC Leiden Netherlands Recruiting
Maastricht UMC Maastricht Netherlands Not Yet Recruiting
Radboud UMC Nijmegen Netherlands Not Yet Recruiting
Erasmus MC Rotterdam Netherlands Not Yet Recruiting
UMC Utrecht Utrecht Netherlands Not Yet Recruiting
Isala Klinieken Zwolle Netherlands Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07645625 on ClinicalTrials.gov ↗ ← All trials in the Netherlands