Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

Sponsor
University Medical Center Groningen
Study ID
NCT07645625
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
Jun 12, 2026
Start date
May 11, 2026
Status verified
May 2026
Primary completion
May 31, 2030
Completion
Feb 28, 2039

Study Design

Enrollment
261 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Observation cohort
    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.
  • Experimental: Discontinuation cohort
    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.

Primary Outcome Measure

Evaluate the progression-free survival (PFS) and compare to the KEYNOTE-826 trial [ Time Frame: 12 months; for all patients ]

Central Contacts

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