RecruitingPhase 1Phase 2NCT07718243

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

A Phase I/II Trial of Bexmarilimab and Nivolumab in Patients With Solid Tumours, Non-Small Cell Lung Cancer and Melanoma


Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

62 participants

Start Date

Aug 28, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bexmarilimab 1mg/kg and nivolumab 1mg/kg, a drug called Bexmarilimab 3mg/kg and nivolumab 1mg/kg, and others for people with melanoma (skin cancer), non-small cell lung cancer, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBexmarilimab 1mg/kg and nivolumab 1mg/kg

Dose Level 1

DRUGBexmarilimab 3mg/kg and nivolumab 1mg/kg

Dose Level 2

DRUGRecommended Phase II Dose

Recommended Phase II Dose of bexmarilimab in combination with nivolumab established from Dose Escalation


Locations(2)

The Christie NHS Foundation Trust

Manchester, United Kingdom

The Royal Marsden NHS Foundation Trust - Drug Development Unit

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07718243


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