BO-112 With Pembrolizumab in Unresectable Malignant Melanoma

Sponsor
Highlight Therapeutics
Study ID
NCT04570332
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BO-112 plus pembrolizumab — DRUG
    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
  • Tissue Biopsies — PROCEDURE
    Pre and post (if feasible) treatment tumor tissue biopsies will be used for correlative research.

Study Details

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.

Key Dates

Start date
Dec 30, 2020
Status verified
Nov 2025
Primary completion
Oct 3, 2023
Completion
Nov 4, 2024

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Patients will be treated with a combination of IT BO-112 and IV pembrolizumab.BO-112 will be administered once weekly (QW) for the first 7 weeks and then once every three weeks (Q3W); pembrolizumab Q3W will be administered IV. BO-112 will be administered IT at a total dose of 1-2 mg at each administration to 1-8 tumor lesions.

Primary Outcome Measure

Overall Response Rate [ Time Frame: From the first dose of study treatment to the date of CR or PR assessed up to 2 years ]

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