Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT05756556
Status:
SUSPENDED
Last Update Posted:
2024-02-01
First Post:
2022-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma
Sponsor:
ImmVira Pharma Co. Ltd
Organization:
Study Overview
Official Title:
A Phase 2a, Open-label Study of T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma
Status:
SUSPENDED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in drug development and lifecycle management and decide to suspend this study
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the efficacy and safety of T3011 in combination with Cobimetinib in patients with advanced melanoma.
Detailed Description:
This is a phase 2a, open-label study of T3011 given via intratumoral (IT) injection in combination with Cobimetinib given via oral administration in patients with advanced melanoma. This study is planned to enroll approximately 62\~68 patients with BRAF V600E/V600K mutation-positive or RAS mutation-positive, which will be conducted in 2 parts (part 1 and part 2).
Study Oversight
Has Oversight DMC:
False
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?: