RecruitingPhase 2NCT06180733

Neo-adjuvant Pembrolizumab as an Alternative Treatment for MMRd Uterine Cancer

Neo-adjuvant Pembrolizumab as an Alternative Treatment for MMRd Uterine Cancer, a Phase II Efficacy Study


Sponsor

University Medical Center Groningen

Enrollment

12 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving pembrolizumab — an immunotherapy drug that helps the immune system fight cancer — before surgery can shrink or eliminate uterine cancer, potentially making surgery less extensive. The study focuses on a specific type: Grade 3 or clear-cell uterine cancer with a defect in the DNA mismatch repair system (MMRd), which makes tumors more likely to respond to immunotherapy. **You may be eligible if...** - You are a woman 18 or older with a confirmed diagnosis of Grade 3 or clear-cell uterine cancer - Your tumor has been tested and found to have mismatch repair deficiency (MMRd) - You are planned for surgical removal of the uterus (hysterectomy) - You are not currently pregnant **You may NOT be eligible if...** - Your uterine cancer does not have mismatch repair deficiency - Your cancer is a different grade or type not covered by this study - You have autoimmune disease or have had prior immunotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab 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.


Locations(1)

University Medical Centre Groningen

Groningen, Netherlands

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NCT06180733


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