NCT07645625 Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer
| NCT ID | NCT07645625 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Medical Center Groningen |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 261 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 261 participants in total. It began in 2026-05-11 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
M. Jalving
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT07645625 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07645625 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07645625 currently recruiting?
Yes, NCT07645625 is actively recruiting participants. Contact the research team at m.jalving@umcg.nl for enrollment information.
Where is the NCT07645625 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Amsterdam, Netherlands, Eindhoven, Netherlands, Enschede, Netherlands and 7 additional locations.
Who is sponsoring the NCT07645625 clinical trial?
NCT07645625 is sponsored by University Medical Center Groningen. The principal investigator is M. Jalving at University Medical Center Groningen. The trial plans to enroll 261 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.