Can cervical cancer patients stop immunotherapy early? new study investigates
NCT ID NCT07645625
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This study follows 261 people with persistent, recurrent, or metastatic cervical cancer who are taking pembrolizumab (Keytruda) with or without bevacizumab (Avastin). Some participants may choose to stop pembrolizumab early if their tumor shrinks or disappears, while others continue standard treatment. Researchers will track how long the cancer stays under control and compare results to previous trials, aiming to see if early discontinuation is a safe option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab (Keytruda) with or without bevacizumab (Avastin)
- What this could lead to
- If successful, this could show that stopping pembrolizumab early is safe and effective for some patients with advanced cervical cancer, potentially reducing treatment burden.
- What could go wrong
- This is an observational registry, not a controlled trial, so results may be less definitive. Early discontinuation might lead to higher relapse risk, and findings may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 261 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Feb 2039
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam UMC
NOT_YET_RECRUITINGAmsterdam, Netherlands
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Antoni van Leeuwenhoek Ziekenhuis
NOT_YET_RECRUITINGAmsterdam, Netherlands
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Catharina Ziekenhuis
RECRUITINGEindhoven, Netherlands
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Erasmus MC
NOT_YET_RECRUITINGRotterdam, Netherlands
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Isala Klinieken
NOT_YET_RECRUITINGZwolle, Netherlands
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LUMC
RECRUITINGLeiden, Netherlands
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Maastricht UMC
NOT_YET_RECRUITINGMaastricht, Netherlands
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Medisch Spectrum Twente
NOT_YET_RECRUITINGEnschede, Netherlands
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Radboud UMC
NOT_YET_RECRUITINGNijmegen, Netherlands
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UMC Utrecht
NOT_YET_RECRUITINGUtrecht, Netherlands
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University Mecdical Center Groningen
RECRUITINGGroningen, 9713 GZ, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can pulsed radiation extend life in metastatic cervical cancer?
- Can an immunotherapy boost give advanced cervical cancer patients more time?
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Smart speculum could bring cervical cancer screening to remote areas
- Your gut bacteria may hold the key to whether immunotherapy works