A Phase 4 interventional study of Early discontinuation of Pembrolizumab with or without Bevacizumab in Cervical Cancer, sponsored by University Medical Center Groningen. Recruiting at 11 sites in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by University Medical Center Groningen · Phase 4, Interventional, and Treatment
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
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 261 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
- Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.
Inclusion criteria for the early discontinuation cohort:
Choice made to stop pembrolizumab for one of the following reasons:
Exclusion criteria for all cohorts are:
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.
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.
Drug: 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).
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.
Time frame: 12 months; for all patients
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.
Time frame: 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%.
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)
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.
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)
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.
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
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).
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.
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).
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
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
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
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.
Time frame: From enrollment till the end of treatment (two years from commencing treatment), every three months both questionnaires will be sent.
Plan to share: Undecided
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University Medical Center Groningen