endometrial cancer uterine cancer
Conditions
Interventions
Pembrolizumab, 200mg IV Q3W for a total of 2 administrations per patient
integrated into standard-of-care protocol prior to surgery.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 dMMR/POLE-EDM uterine cancer who are intended to be treated with hysterectomy will be enrolled in this study. - 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 the contraceptive guidance in section 5.2 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
Exclusion criteria: - A woman who has a positive urine pregnancy test within 72 hours prior to allocation. - 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 - Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation. - Has received prior radiotherapy within 2 weeks of start of study treatment. - Has received a live vaccine within 30 days prior to the first dose of study drug. - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. - Has known active CNS metastases and/or carcinomatous meningitis. - Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients. - Has active autoimmune disease that has required systemic treatment in the past 2 years - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Has an active infection requiring systemic therapy. - Has a known history of Human Immunodeficiency Virus (HIV). - Hepatitis B of C - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject*s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. - Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to assess pathological response will be determined on tumor tissue collected during standard of care hysterectomy. Which is planned approximately 3 weeks after the second cycle of pembrolizumab.. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secundary endpoint is to assess the radiograpic response is measured by MRI using RECIST 1.1 criteria. Baseline MRI will be scheduled before start therapy. The follow-up MRI scan is scheduled as close to the hysterectomy as possible (approximatly 3 weeks after the second cycle of pembroluzimab.) | — |
Countries
Netherlands
Outcome results
None listed