Frontline Immunotherapy Combined With Radiation and Chemotherapy in High Risk Endometrial Cancer
NCT03932409 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-05-08
Summary
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.
Conditions
Interventions
- DRUG
-
prior to VCB: 200mg IV given one week (7 days) before radiation after VCB: 200mg IV on day 1 of a 21 day cycle prior to chemotherapy
- RADIATION
-
Vaginal cuff brachytherapy (VCB)
Treatment should commence within 12 weeks of the surgery/hysterectomy
- DRUG
-
after VCB, Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
- DRUG
-
after VCB, Carboplatin IV on day 1 of a 21 day cycle for 3 cycles
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Oklahoma
lead OTHER
Principal Investigators
-
Christina Washington, MD · Stephenson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-19
- Primary Completion
- 2025-09-25
- Completion
- 2027-06-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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