Neo-adjuvant Pembrolizumab as an Alternative Treatment for MMRd Uterine Cancer (NCT06180733) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neo-adjuvant Pembrolizumab as an Alternative Treatment for MMRd Uterine Cancer
Netherlands12 participantsStarted 2023-12-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed primary diagnosis of G3/CC MMRd uterine cancer who are intended to be treated with hysterectomy.
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, is not a woman of childbearing potential (WOCBP) or agrees to follow contraceptive guidance during the treatment period and at least until standard-of-care hysterectomy.
* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Exclusion Criteria:
* A WOCBP who has a positive serum pregnancy test at screening.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \[could consider shorter interval for kinase inhibitors or other short half-life drugs\] prior to allocation.
* Has received prior radiotherapy within 2 weeks of start of study treatment or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease with a 1-week washout is permitted.
* Has received a live vaccine or live-attenuated vaccine within 30 days before to the first dose of study intervention. Administration of killed va…
What they're measuring
1
Establish fraction of patients that achieve major pathologic response
Timeframe: Tumor tissue is collected during standard of care hysterectomy (6 months after baseline)