eo-adjuvant Pembrolizumab in dMMR/ POLE-EDM uterine cancer patients: a feasibility study
- Conditions
- endometrial canceruterine cancer10038594
- Registration Number
- NL-OMON49601
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to assess pathological response will be determined on<br /><br>tumor tissue collected during standard of care hysterectomy. Which is planned<br /><br>approximately 3 weeks after the second cycle of pembrolizumab..</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secundary endpoint is to assess the radiograpic response is measured by MRI<br /><br>using RECIST 1.1 criteria. Baseline MRI will be scheduled before start therapy.<br /><br>The follow-up MRI scan is scheduled as close to the hysterectomy as possible<br /><br>(approximatly 3 weeks after the second cycle of pembroluzimab.)</p><br>