NCT05819892

Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 survival Exploratory: * To determine if the presence of deficient mismatch repair (dMMR) or microsatellite instability correlates with progression free survival, disease free survival and 5-year overall survival * To assess patient reported outcomes (PROs) during the course of treatment and follow up

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given by IV (vein)
DRUG	Carboplatin	Given by IV (vein)
DRUG	Dostarlimab	Given by IV (vein)
DRUG	Cisplatin	Given by IV (vein)

Timeline

• Start date: 2023-07-17
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2023-04-19
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study