Cervical CancerPhase 4PROTECxNCT07645625
Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer
A Phase 4 study testing Early discontinuation of Pembrolizumab with or without Bevacizumab in people with Cervical Cancer, run by University Medical Center Groningen at 11 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Early discontinuation of Pembrolizumab with or without Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 11 sitesNetherlands
- Study dates
- 11 May 2026to Feb 2039
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.
- 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)
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Netherlands11 sites, 11 recruiting
- Not yet recruiting
Amsterdam UMC
Amsterdam
J. Tromp, j.m.tromp@amsterdamumc.nl
J. Tromp
- Not yet recruiting
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam
M. A. Rijlaarsdam, m.rijlaarsdam@nki.nl
M. A. Rijlaarsdam
- Recruiting
Catharina Ziekenhuis
Eindhoven
A. M.J. Thijs, annemarie.thijs@catharinaziekenhuis.nl
A. M.J. Thijs
- Not yet recruiting
Medisch Spectrum Twente
Enschede
A. N.M. Wymenga, a.wymenga@mst.nl
A. N.M. Wymenga
- Recruiting
University Mecdical Center Groningen
Groningen, 9713 GZ
M. Jalving, MD, PhD, +31 50 3612821, m.jalving@umcg.nl
A. K.L. Reyners, MD, PhD, +31 50 3612821, a.k.l.reyners@umcg.nl
- Recruiting
LUMC
Leiden
J. R. Kroep, j.r.kroep@lumc.nl
J. R. Kroep
- Not yet recruiting
Maastricht UMC
Maastricht
A. J.M. Beijers, tonneke.beijers@mumc.nl
A. J.M. Beijers
- Not yet recruiting
Radboud UMC
Nijmegen
V. Soomers, Vicky.Soomers@radboudumc.nl
V. Soomers
- Not yet recruiting
Erasmus MC
Rotterdam
I. A. Boere, i.boere@erasmusmc.nl
I. A. Boere
- Not yet recruiting
UMC Utrecht
Utrecht
I. O. Baas, i.o.baas-3@umcutrecht.nl
I. O. Baas
- Not yet recruiting
Isala Klinieken
Zwolle
W. A. van der Steeg, w.a.van.der.steeg@isala.nl
W. A. van der Steeg
About this study
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
- Conditions
- Cervical Cancer
- Being tested
- Early discontinuation of Pembrolizumab with or without Bevacizumab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early discontinuation of Pembrolizumab with or without BevacizumabDrug
- Keytruda, (L01XC18), pembrolizumab, intravenous administration (administered as standard of care).
- Avastin, (L01FG01), bevacizumab, intravenous administration (administered as standard of care).
| Study group | Role | What they receive |
|---|---|---|
| Observation cohort | No intervention | 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. |
| Discontinuation cohort | Experimental | 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. Receives: Drug: Early discontinuation of Pembrolizumab with or without Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the progression-free survival (PFS) and compare to the KEYNOTE-826 trial
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.
Measured: 12 months; for all patients
Secondary outcomes (8)
Evaluate progression-free survival (PFS) at 12- and 24 months
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.
Measured: 12 and 24 months; for all patients
To evaluate Overall Survival (OS)
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%.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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).
Measured: 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.
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).
Measured: 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
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
Measured: 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
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.
Measured: From enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start11 May 2026
- Primary completionMay 2030 (estimated)
- Study completionFeb 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Jalving, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645625
- Sponsor's protocol ID
- 22590
- Acronym
- PROTECx
- Status last verified
- May 2026
- First submitted
- 5 Jan 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer
- ClinicalTrials.gov ID
- NCT07645625
- Acronym / sponsor ID
- PROTECx / 22590
- Conditions
- Cervical Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 261 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Feb 2039 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation cohort | No intervention | –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. |
| Discontinuation cohort | Experimental | Drug: Early discontinuation of Pembrolizumab with or without BevacizumabThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.
- Previous inclusion in the observation cohort
- Choice made to stop pembrolizumab for one of the following reasons:
- Eligible and willing to discontinue pembrolizumab (with or without discontinuing bevacizumab)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early discontinuation of Pembrolizumab with or without Bevacizumab1. Keytruda, (L01XC18), pembrolizumab, intravenous administration (administered as standard of care). 2. Avastin, (L01FG01), bevacizumab, intravenous administration (administered as standard of care). | Drug | Discontinuation cohort |
Primary outcome
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.
8 secondary outcomes
Evaluate progression-free survival (PFS) at 12- and 24 months
Time frame: 12 and 24 months; for all patients
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
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.
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 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.
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.
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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
M. Jalving principal investigator
University Medical Center Groningen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early discontinuation of Pembrolizumab with or without Bevacizumab in people with Cervical Cancer, run by University Medical Center Groningen at 11 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact M. Jalving, MD, PhD (+31 50 361 2821, m.jalving@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the progression-free survival (PFS) and compare to the KEYNOTE-826 trial (time frame: 12 months; for all patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.