Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

ClinicalTrials.gov ID

NCT07645625

Lead Sponsor

University Medical Center GroningenOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

261Estimated

Last Update Posted

Jun 29, 2026Actual

Start Date

May 11, 2026Actual

Primary Completion Date

May 2030Estimated

Completion Date

Feb 2039Estimated

Official Title

Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

Brief 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

• Cervical Cancer

• Early discontinuation of Pembrolizumab with or without Bevacizumab

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Medical Center GroningenOTHER

m.rijlaarsdam@nki.nl

annemarie.thijs@catharinaziekenhuis.nl

a.wymenga@mst.nl

j.r.kroep@lumc.nl

tonneke.beijers@mumc.nl

Vicky.Soomers@radboudumc.nl

i.boere@erasmusmc.nl

i.o.baas-3@umcutrecht.nl

w.a.van.der.steeg@isala.nl

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