Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer
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
∙ • Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.
• Previous inclusion in the observation cohort
• 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)