Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04570332
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-29
First Post:
2020-09-22
Brief Title:
BO-112 With Pembrolizumab in Unresectable Malignant Melanoma
Sponsor:
Highlight Therapeutics
Organization:
Highlight Therapeutics
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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 andor metastatic melanoma that have progressed on anti-PD-1-containing treatment
Detailed Description:
Patients will be treated with the combination of BO-112 and pembrolizumab IT administration of BO-112 will be performed once weekly QW for the first 7 weeks and then once every three weeks Q3W pembrolizumab Q3W will be administered IV After enrolment of 40 patients the sponsor and investigators will review the overall response rate ORR durability of response DOR disease control rate DCR and safety profile and will decide whether to initiate a subsequent randomized phase of the trial
The order of administration should be pembrolizumab then IT BO-112 BO-112 will be administered IT at a total dose of 1-2 mg at each administration to 1-8 tumor lesions using tuberculin TB syringes or equivalent with 20- to 25-gauge needles The needle type can also be per the investigators discretion to best distribute the study drug within the lesion Repeat IT dosing may occur if the lesions remains palpable or detectable by ultrasound after which only pembrolizumab infusion will continue
BO-112 can be administered IT into multiple accessible lesions amenable to repeat administration using an appropriate syringe and needle type for the location of the lesions The rationale for dosing multiple lesions is to produce an immune response against a wider range of genetic mutations and antigenic diversity than may occur within a single lesion which in turn is expected to reduce the chance of immune escape by the tumor
The order of administration should be pembrolizumab then IT BO-112 BO-112 will be administered IT at a total dose of 1-2 mg at each administration to 1-8 tumor lesions using tuberculin TB syringes or equivalent with 20- to 25-gauge needles The needle type can also be per the investigators discretion to best distribute the study drug within the lesion Repeat IT dosing may occur if the lesions remains palpable or detectable by ultrasound after which only pembrolizumab infusion will continue
BO-112 can be administered IT into multiple accessible lesions amenable to repeat administration using an appropriate syringe and needle type for the location of the lesions The rationale for dosing multiple lesions is to produce an immune response against a wider range of genetic mutations and antigenic diversity than may occur within a single lesion which in turn is expected to reduce the chance of immune escape by the tumor
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003921-51 | EUDRACT_NUMBER | None | None |
| KEYNOTE-B77 MK-3475-B77 | OTHER_GRANT | Merck Sharp Dohme LLC | None |