Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 7:29 AM
Study NCT ID:
NCT04444193
Status:
UNKNOWN
Last Update Posted:
2020-06-23
First Post:
2020-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Durvalumab and Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma
Sponsor:
Shanghai First Maternity and Infant Hospital
Organization:
Study Overview
Official Title:
Safety and Efficacy Study of Durvalumab in Combination With Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma--DULECT Trial
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dulect2020-2
Brief Summary:
This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib in participants with advanced and recurrent endometrial carcinoma.The primary hypothesis of this study are that patients with advanced and recurrent endometrial carcinoma could benefit from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; 2) Objective Response Rate (ORR); and Overall survival (OS). The investigators design a clinical study to explore whether the combination above as a treatment in patients with advanced and recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker of therapeutic response.
Detailed Description:
The combination of Lenvatinib and Programmed death-ligand 1 (PD-L1) blocking has great potential in the treatment of advanced and recurrent endometrial cancer. This trial is designed as a prospective, open label study for 20 patients with advanced (recurrent, refractory or metastatic) endometrial cancer, including carcinosarcoma of the uterus. The aim is to investigate the efficacy of the combination therapy of Lenvatinib 80-120mg daily orally and durvalumab 1500mg by IV infusion every 4 weeks in terms of progression free survival.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: