Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04546074
Status:
RECRUITING
Last Update Posted:
2023-10-03
First Post:
2020-08-29
Brief Title:
Imatinib Mesylate in Combination With Pembrolizumab in Patients With Melanoma
Sponsor:
Keio University
Organization:
Keio University
Study Overview
Official Title:
Imatinib Mesylate in Combination With Pembrolizumab in Patients With Advanced KIT-mutant Melanoma Following Progression on Standard Therapy a Phase III Trial
Status:
RECRUITING
Status Verified Date:
2023-10
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 is an open-labelled single arm trial of pembrolizumab and imatinib mesylate in subjects with unresectable or metastatic KIT-mutant melanoma that are refractory to standard therapy The phase Ib and II study will be conducted to evaluate the safety tolerability and response rate data of this combination therapy KIT-mutant tumors will be confirmed in previously biopsied tumors This analysis will be done by next-generation sequencing
Detailed Description:
This trial is conducted as Advanced medicine authorized by the Ministry of Health Labor and Welfare MHLW in Japan and in in conformance with Clinical Trial Act
PIb study is a dose-escalation study comprising two dose levels of imatinib mesylate with fixed dose of pembrolizumab to evaluate safety and tolerability and identify maximum tolerated doseadministered and determine recommended phase 2 dose RP2D
In PII study a Simons minimax two-stage design is employedThe treatment period with the combination therapy of both studies will continue every 21 days for up to 33 cycles approximately 2 years as long as subjects are receiving benefit from treatment and have not had disease progression or met any criteria for study withdrawal
PIb study is a dose-escalation study comprising two dose levels of imatinib mesylate with fixed dose of pembrolizumab to evaluate safety and tolerability and identify maximum tolerated doseadministered and determine recommended phase 2 dose RP2D
In PII study a Simons minimax two-stage design is employedThe treatment period with the combination therapy of both studies will continue every 21 days for up to 33 cycles approximately 2 years as long as subjects are receiving benefit from treatment and have not had disease progression or met any criteria for study withdrawal
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?:
False
Is an FDA AA801 Violation?:
None