Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
M.D. Anderson Cancer Center
Summary
To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied
Description
Primary Objectives: The primary objective of this study is to describe the safety and toxicity of chemoradiation with concurrent immunotherapy, followed by chemotherapy plus concurrent immunotherapy, followed by immunotherapy maintenence in patients with stage IIIC endometrial cancer. Secondary Objectives: The secondary objectives are listed below. * To estimate progression free survival * To describe the time to recurence and the recurrence patterns including extent and location (i.e. isolated versus multi-focal, pelvic versus distant) * To estimate disease specific survival and overall s…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: Patients are eligible to participate on this study only if they meet all of the following inclusion criteria. 1. Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures 2. Have surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype and be eligible for adjuvant chemoradiation followed by chemotherapy (Note: Surgical staging is defined as total hysterectomy and lymph node assessment.) 3. Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surg…
Interventions
- DrugPaclitaxel
Given by IV (vein)
- DrugCarboplatin
Given by IV (vein)
- DrugDostarlimab
Given by IV (vein)
- DrugCisplatin
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas