BO-112 With Pembrolizumab in Unresectable Malignant Melanoma

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.

Timeline

Start

2020-12-30

Primary completion

2023-10-03

Completion

2024-11-04

Outcome

Met primary endpoint

paper The clinical trial has met its primary end point (ORR) PMID 40577656 ↗

paper For mITT, there were 40 patients and the ORR was 25% PMID 40577656 ↗

Publications

• Marquez-Rodas I, Dutriaux C, Saiag P, de la Cruz Merino L, Castanon Alvarez E, Robert C, Rodriguez-Moreno JF, Arance A, Cerezuela-Fuentes P, Montaudie H, Sanmamed MF, Gonzalez-Cao M, Charles J, Lopez Criado MP, Berrocal A, de Miguel E, Funck-Brentano E, Prey S, Alamo de la Gala MC, Melero I, Aviles-Izquierdo JA, Roman R, Garcia-Pelaez B, Rodriguez S, Trnkova ZJ, Quintero M, Macia S, Chaney MF, Dalle S. BO-112 Plus Pembrolizumab for Patients With Anti-PD-1-Resistant Advanced Melanoma: Phase II Clinical Trial SPOTLIGHT-203. J Clin Oncol. 2025 Sep;43(25):2806-2815. doi: 10.1200/JCO-24-02595. Epub 2025 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BO-112	Oligonucleotide (other)	2 mg	Other
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications