UZ Leuven and VIB-KU Leuven Launch Innovative Melanoma Study with First Patient Treated

In a landmark step for melanoma research, UZ Leuven and the VIB-KU Leuven Center for Cancer Biology, in collaboration with Seattle-based Presage Biosciences, have treated the first patient in a groundbreaking clinical trial focused on advanced skin cancer. The trial is a non-randomized, open-label Phase I pilot study, conducted at a single center, and is designed to investigate how melanoma tumors respond when treated with multiple cancer drugs injected directly into the tumor — all while patients are also receiving standard systemic anti-PD1 immunotherapy.

The trial targets patients with metastatic (stage IV) or inoperable stage III melanoma. Eligible participants are those whose tumors are castration-resistant and express PSMA, a protein associated with prostate and melanoma cancers. In this study, up to seven investigational drugs are microdosed directly into the tumor using Presage’s Comparative In Vivo Oncology (CIVO®) microinjection platform. The goal is to test localized responses to various drug candidates and evaluate how they may enhance the effects of systemic anti-PD1 treatment.

The injected areas within the tumor are then analyzed using advanced single-cell spatial profiling technologies, enabling researchers to gain deep biological insight into each tumor’s molecular landscape and how it responds to the therapies. This provides an unprecedented look at the real-time interplay between local drug activity and immune response during combination treatment.

“This is the first trial to explore the effects of locally administered cancer drugs in tandem with systemic anti-PD1 immunotherapy at such an early point in treatment,” said Prof. Dr. Oliver Bechter, a medical oncologist at UZ Leuven. “With this pilot study, we hope to demonstrate the feasibility of testing intratumoral drug combinations early in the treatment process, especially for patients who might not respond to current standard immunotherapies.”

Prof. Dr. Chris Marine, a cancer biologist at the VIB-KU Leuven Center for Cancer Biology, emphasized the importance of the translational research opportunity: “This innovative platform bridges the lab and the clinic, allowing us to test our most promising discoveries directly in patients. By leveraging our expertise in spatial multi-omics, we’ll be able to decode how each tumor responds to different combinations, accelerating the development of personalized therapies.”

The trial is made possible by Presage’s CIVO technology, which allows multiple drugs to be tested simultaneously in a single patient tumor, without requiring systemic exposure. This approach is gaining momentum in early-phase trials for its ability to provide actionable data on drug activity, immune engagement, and resistance mechanisms — all without waiting for full-body dosing or large-scale studies.

Jason Frazier, VP of Technology and Research Operations at Presage, praised the collaborative effort: “Drs. Bechter and Marine have designed an exciting clinical study that truly personalizes therapy evaluation. With CIVO, we’re able to see how tumors react to different drugs and immune checkpoint inhibitors in real time. This type of insight could be transformative for patients with difficult-to-treat cancers like melanoma.”

About the Partners

• VIB-KU Leuven Center for Cancer Biology focuses on uncovering the biological drivers of cancer to develop better diagnostics and treatments.

• UZ Leuven is a major academic hospital in Belgium known for pioneering patient care, research, and education.

• Presage Biosciences is an innovator in oncology drug development, using microdosing and spatial analysis to improve early-phase clinical research.