NCT04570332

BO-112 With Pembrolizumab in Unresectable Malignant Melanoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Highlight Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	BO-112 plus pembrolizumab	Patients will be treated with the combination of BO-112 and pembrolizumab. 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
PROCEDURE	Tissue Biopsies	Pre and post (if feasible) treatment tumor tissue biopsies will be used for correlative research.

Timeline

• Start date: 2020-12-30
• Primary completion: 2023-10-03
• Completion: 2024-11-04
• First posted: 2020-09-30
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

19 sites across 2 countries: France, Spain