Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-28 @ 4:23 AM
Study NCT ID:
NCT04570332
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2020-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BO-112 With Pembrolizumab in Unresectable Malignant Melanoma
Sponsor:
Highlight Therapeutics
Organization:
Study Overview
Official Title:
Phase 2 Single Arm Clinical Study to Evaluate the Efficacy and Safety of Intratumoral Administration of BO-112 in Combination With Pembrolizumab in Subjects That Have Progressed on Anti-PD-1-based Therapy for Stage III or IV Melanoma
Status:
COMPLETED
Status Verified Date:
2025-11
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:
SPOTLIGHT203
Brief Summary:
This is a phase 2, single arm, open label, adaptive design study to determine the preliminary anti-tumor activity and confirm the safety of IT BO-112 in combination with intravenous (IV) pembrolizumab. The study will enroll patients with advanced and/or metastatic melanoma that have progressed on anti-PD-1-containing treatment.
Detailed Description:
Patients with advanced Stage III/IV melanoma, refractory or resistant to anti-PD-1 treatment, were treated with the combination of intra-tumoral (IT) BO-112 and Q3W IV pembrolizumab. IT administration of BO-112 was performed once weekly (QW) for the first 7 weeks and then once every three weeks (Q3W).
The primary and secondary endpoints include overall response rate (ORR), durability of response (DOR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and safety profile.
The primary and secondary endpoints include overall response rate (ORR), durability of response (DOR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and safety profile.
Study Oversight
Has Oversight DMC:
True
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?: