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ACTIVE NOT RECRUITING
NCT03932409
PHASE1

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

Sponsor: University of Oklahoma

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2020-02-19

Completion Date

2026-09

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

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

Locations (2)

LSU Health New Orleans

New Orleans, Louisiana, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States