Experimental combo shows promise for Hard-to-Treat melanoma

NCT ID NCT04570332

Completed Disease control Sponsor: Highlight Therapeutics Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a combination of two drugs—BO-112, injected directly into tumors, and pembrolizumab, given through a vein—in 42 adults with advanced melanoma that had stopped responding to standard immunotherapy. The goal was to see if the combo could shrink tumors and be safe. Participants had stage III or IV melanoma and had already progressed on anti-PD-1 therapy.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: BO-112 (injected into tumors) plus pembrolizumab (given intravenously)
What this could lead to: If successful, this combination could offer a new treatment option for advanced melanoma patients whose cancer stopped responding to standard immunotherapy.
What could go wrong: This is a small, early-phase trial with only 42 participants and no comparison group, so results may not apply broadly. The treatment involves injections into tumors and carries risks like injection site reactions and immune-related side effects.

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Conditions

The condition(s) this trial relates to.

melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MELANOMA

Contacts and locations

Locations

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France
Centre Hospitalier Universitaire de Grenoble

Grenoble, France
Centre Hospitalier Universitaire de Nantes

Nantes, France
Centre Hospitalier Universitaire de Nice

Nice, France
Clínica Universidad de Navarra

Pamplona, Spain
H. General Universitario de Valencia

Valencia, Spain
H. Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain
H. Universitari Quirón Dexeus

Barcelona, Spain
Hopital Lyon Sud

Lyon, France
Hospital Clara Campal - HM Sanchinarro

Madrid, Spain
Hospital Clinic de Barcelona

Barcelona, Spain
Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain
Hospital General Universitario Gregorio Marañón

Madrid, Spain
Hospital Universitario 12 de Octubre

Madrid, Spain
Hospital Universitario Virgen Macarena

Seville, Spain
Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain
Hôpital Ambroise-Paré

Paris, France
Institut Gustave Roussy

Paris, France
MD Anderson Cancer Center

Madrid, Spain

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