Status and phase
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About
The purpose of this single arm, open label study is to evaluate the feasibility of pembrolizumab combined with radiation administered to the upper part of the vagina (vaginal cuff brachytherapy) followed by three cycles of pembrolizumab and chemotherapy in patients with endometrial cancer.
Full description
Before the patient begins the study:
Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of the ovaries, and removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning.
Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care. Tumor tissue will need to be collected for study tests to see if the patient is eligible for to take part on the study.
TREATMENT If the patient is eligible, pembrolizumab will be given 7 days before radiation therapy. After radiation therapy, three cycles of pembrolizumab and chemotherapy will be given.
Study participation will be up to two years.
Enrollment
Sex
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Volunteers
Inclusion criteria
All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory.
Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged.
If either a bilateral salpingo-oophorectomy (BSO) or nodal sampling was not performed, post-operative pre-treatment CT/MRI is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a BSO and/or lymphnode sampling was not performed.
Tissue from an archival sample or newly obtained core or excisional biopsy of a tumor lesion within 10 weeks confirming diagnosis.
All patients will be staged according to the FIGO 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:
age ≥18 years with 3 risk factors
Risk factors:
Patients must have ECOG performance status 0 or 1.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial and authorization permitting release of personal health information.
Neuropathy (sensory and motor) ≤ Grade 1.
Have adequate organ function as defined per Protocol.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
45 participants in 1 patient group
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Central trial contact
Lead Gyn Nurse
Data sourced from clinicaltrials.gov
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