Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

NCT07645625 | Recruiting Phase 4 DMC

• 1 other identifier: 22590
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 11

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

Conditions

Cervical Cancer

Outcome Measures

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.

  12 months; for all patients

Secondary Outcomes (8)

• Evaluate progression-free survival (PFS) at 12- and 24 months

  12 and 24 months; for all patients

• To evaluate Overall Survival (OS)

  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)

  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)

  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

  from commencement of treatment to the end of regular follow-up (+/- 48 months) or disease progression.

Study Arms (2)

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.

Drug: Early discontinuation of Pembrolizumab with or without Bevacizumab

Interventions

Early discontinuation of Pembrolizumab with or without Bevacizumab DRUG

1. Keytruda, (L01XC18), pembrolizumab, intravenous administration (administered as standard of care). 2. Avastin, (L01FG01), bevacizumab, intravenous administration (administered as standard of care).

Discontinuation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (11)

Amsterdam UMC

Amsterdam, Netherlands

NOT YET RECRUITING

Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

NOT YET RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

NOT YET RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

NOT YET RECRUITING

University Mecdical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

LUMC

Leiden, Netherlands

NOT YET 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

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• M. Jalving

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Jalving, MD, PhD

CONTACT

+31 50 361 2821; m.jalving@umcg.nl

G. M.M. Lenis, MD

CONTACT

+31 50 361 6161; g.m.m.lenis@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: June 12, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): February 1, 2039
• Last Updated: June 12, 2026

Record last verified: 2026-05

Locations

NL (11)