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)
Evaluate the progression-free survival (PFS) and compare to the KEYNOTE-826 trial — 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.
Trial sites (11)
Facility
City
Region
Status
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
More University Medical Center Groningen trials in the Netherlands
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.