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

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
University of Oklahoma
Study ID
NCT03932409
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — 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
  • Vaginal cuff brachytherapy (VCB) — RADIATION
    Treatment should commence within 12 weeks of the surgery/hysterectomy
  • Paclitaxel — DRUG
    after VCB, Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
  • Carboplatin — DRUG
    after VCB, Carboplatin IV on day 1 of a 21 day cycle for 3 cycles

Study Details

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.

Key Dates

First listed
Apr 30, 2019
Start date
Feb 19, 2020
Status verified
May 2026
Primary completion
Sep 25, 2025
Completion
Jun 25, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Radiation Therapy + Pembrolizumab/Chemotherapy
    Pembrolizumab given 7 days prior to radiation therapy (e.g., vaginal cuff brachytherapy) followed by three cycles pembrolizumab combined with Carboplatin/Paclitaxel chemotherapy

Primary Outcome Measure

Proportion of patients completing three cycles [ Time Frame: 4 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
LSU Health New OrleansNew OrleansLouisiana70112-
Stephenson Cancer CenterOklahoma CityOklahoma73104-

Find similar trials in New Orleans, LA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
LSU Health New Orleans· New Orleans, LAStephenson Cancer Center· Oklahoma City, OK

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