Neo-adjuvant Pembrolizumab as an Alternative Treatment for MMRd Uterine Cancer
NCT06180733 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-05-01
Summary
The goal of this clinical trial is to establish the fraction of patients that achieve a major pathological response (MPR) after 9 cycles of pembrolizumab, with the ultimate aim of informing a follow-up randomized trial.
Participants will receive 9 cycles of pembrolizumab before their standard of care hysterectomy.
Conditions
Interventions
- DRUG
-
Pembrolizumab Injection [Keytruda]
Pembrolizumab (Keytruda), 200mg IV Q3W for a total of 9 administrations per patient, prior to standard-of-care surgery. Patients will be monitored for response and possible progression using MRI and pipelle biopsies.
Sponsors & Collaborators
- collaborator INDUSTRY
-
University Medical Center Groningen
lead OTHER
Principal Investigators
-
Hans W Nijman, Prof. dr. · University Medical Center Groningen, UMCG
-
Mathilde Jalving, Dr. · University Medical Center Groningen, UMCG
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2027-12-30
- Completion
- 2028-01-31
- FDA Drug
- Yes
Countries
- Netherlands
Study Locations
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