Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03787602
Status:
RECRUITING
Last Update Posted:
2023-03-02
First Post:
2018-12-06
Brief Title:
Navtemadlin KRT-232 With or Without Anti-PD-1Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma
Sponsor:
Kartos Therapeutics Inc
Organization:
Kartos Therapeutics Inc
Study Overview
Official Title:
A Phase 1b2 Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients With p53 Wild-Type p53WT Merkel Cell Carcinoma MCC Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy or in Combination With Avelumab in MCC Patients Who Are Anti-PD-1 or Anti-PD-L1 Treatment Naïve
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
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:
None
Brief Summary:
This study evaluates KRT-232 a novel oral small molecule inhibitor of MDM2 for the treatment of patients with Merkel Cell Carcinoma MCC who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve Inhibition of MDM2 is a novel mechanism of action in MCC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None