drugset / Trial / NCT07718243

Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC

NCT07718243 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

The trial will test if the combination of bexmarilimab and nivolumab can help patients whose cancers have stopped responding to immunotherapy treatment. It will focus on two cancers: non-small cell lung cancer and melanoma. Early research suggests bexmarilimab may change some immune cells inside the tumour so they create a stronger "attack" signal, which could help other immune cells recognise and kill cancer cells more effectively. This may make it easier for PD-1 immunotherapy drugs to work again by helping the immune system stay active against the tumour. This is a Phase I/II clinical trial. In Phase I, researchers will give increasing doses of bexmarilimab together with a standard (fixed) dose of nivolumab to patients with solid tumours, to find the safest and most suitable dose to use going forward (the recommended Phase 2 dose). In Phase II, the study will treat two groups of patients-one with non-small cell lung cancer and one with melanoma-using that selected dose.

Timeline

Start
2026-08-28
Primary completion
2030-01-31
Completion
2030-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 1 mg/kg —
Subject bexmarilimab Monoclonal antibody 1 mg/kg —
Subject bexmarilimab Monoclonal antibody 3 mg/kg —