drugset / Trial / NCT07645625

Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

NCT07645625

Phase 4 Recruiting 261 enrolled University Medical Center Groningen
Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2026-05-11
Primary completion
2030-05
Completion
2039-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody Intravenous
Subject Pembrolizumab Monoclonal antibody Intravenous

Indications