Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-29 @ 12:26 AM
Study NCT ID:
NCT05263492
Status:
TERMINATED
Last Update Posted:
2025-10-02
First Post:
2022-02-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib in Combination With Pembrolizumab in Black Participants With Mismatch Repair-Proficient Recurrent Endometrial Cancer
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed early due to low enrollment rates
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Determine the efficacy of the combination of lenvatinib and pembrolizumab in Black participants
Detailed Description:
This study is a single-arm, open-label, multicenter phase 2 trial designed to prospectively evaluate the safety and efficacy of lenvatinib in combination with pembrolizumab for mismatch repair proficient recurrent endometrial cancer in Black patients (a population under-represented on 2 FDA registration trials).
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 |
|---|---|---|---|---|
| HM20023447 | OTHER | Virginia Commonwealth University | View |