NCT03932409

Frontline Immunotherapy Combined With Radiation and Chemotherapy in High Risk Endometrial Cancer

A Phase Ib Trial of Vaginal Cuff Brachytherapy + Pembrolizumab (MK3475) Followed by 3 Cycles of Dose Dense Paclitaxel/q 21 Day Carboplatin + Pembrolizumab (MK3475) in High Intermediate Risk Endometrial Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	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	Paclitaxel	after VCB, Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
DRUG	Carboplatin	after VCB, Carboplatin IV on day 1 of a 21 day cycle for 3 cycles

Timeline

• Start date: 2020-02-19
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2019-04-30
• Last updated: 2026-02-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study