Results from the IT-MATTERS Phase III trial — 928 patients, one of the largest randomized head and neck cancer studies ever conducted — are now peer-reviewed in a leading journal. Here’s why the whole team should be proud.
Some projects are milestones. This one is a landmark. Findings from IT-MATTERS, the Phase III trial Ergomed delivered for the study sponsor CEL-SCI, have been published in Oral Oncology — one of the most respected peer-reviewed journals in the field. Getting a study of this size into print is the clearest possible signal that the work done stands up to the highest scientific scrutiny.
The numbers speak for themselves. With 928 patients enrolled, IT-MATTERS is among the largest randomized head and neck cancer studies ever conducted anywhere in the world. Delivering a trial of this scale and rigor in a notoriously hard-to-treat indication is exactly the kind of oncology work Ergomed exists to do — and doing it well, end to end, and is something the entire team helped make happen.
The science matters. The publication identifies low and zero tumor PD-L1 expression (TPS <10%) and no neck lymph node involvement as prognostic biomarkers for selecting the patients with resectable, locally advanced (LA) primary oral squamous cell carcinoma (OSCC) and soft palate, as most likely to benefit from neoadjuvant treatment with Leucocyte Interleukin Injection (Multikine®) in combination with CIZ (intravenous low dose cyclophosphamide, indomethacin and zinc multivitamins) prior to standard of care. The study reported a significant overall survival benefit in the biomarker-selected population, supported by significant improvement in progression free survival — findings with real potential to shape how future patients are identified and treated.
And the story isn’t over. CEL-SCI is now advancing into a global confirmatory registration study built directly on these results — with Ergomed continuing as its clinical research organization partner. Moving from a global Phase 3 trial to a confirmatory program with the same sponsor is a genuine vote of confidence in our team and our dedication to delivering high-quality results.
The team behind it
Behind the trial is an Ergomed team with deep head and neck oncology expertise. Dr. Dusan Markovic, VP, Global Medical Affairs, a co-author of the Oral Oncology publication who provided medical and scientific leadership and is a co-author on nine abstracts from this program presented at ESMO, ASCO, ESTRO, ICHNO and AHNO Conferences. He also co-authored the publication of the IT-MATTERS study in Pathology Oncology Research a Frontiers journal last year.
Dr. Markovic was joined by Dr Svitlana Dziumenko -Lead Medical Monitor, Iwona Kmicikiewicz- Project Director, Karolina Bialota – regional Site Manager, Amra Begic/Oleksandr Davydov- regional Clinical Team Managers, Evita Kroehan, Lead Clinical Trial Assistant, Malgorzata Michalik- Regional Regulatory Manager who brought therapeutic / functional expertise. This list is not exhaustive, as many other Ergomed team members also made important contributions to the conduct and successful execution of the IT-MATTERS study.
Together they bring 10+ years of combined experience delivering complex oncology trials for Ergomed.
“We’re incredibly proud to have contributed to a global study of this scale and significance. Head and neck cancer is a difficult indication to treat, and being part of research that could ultimately help bring new treatment options to patients is exactly why we do this work. Seeing the findings published in Oral Oncology is a milestone for everyone involved — and we’re proud to continue this journey with CEL-SCI into the confirmatory study.””
— Dr. Dusan Markovic, VP, Global Medical Affairs, Ergomed