Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-02 @ 1:41 AM
Study NCT ID:
NCT05819892
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2023-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-03071 | OTHER | NCI-CTRP Clinical Trials Registry | View |