Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer
ConditionCervical Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Medical Center Groningen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Previous inclusion in the observation cohort
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Early discontinuation of Pembrolizumab with or without Bevacizumab
Drug1. Keytruda, (L01XC18), pembrolizumab, intravenous administration (administered as standard of care). 2. Avastin, (L01FG01), bevacizumab, intravenous administration (administered as standard of care).
Treatment groups
261 Participants
are divided into 2 treatment groupsGroup A: Observation cohortNo intervention 0 interventions
Group B: Discontinuation cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 patientsSecondary outcomes
1
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 patients2
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 start3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov