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

NCT07718243 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

  • Melanoma (Skin Cancer)
  • Non Small Cell Lung Cancer
  • Solid Tumor in Advanced Stage

Interventions

DRUG

Bexmarilimab 1mg/kg and nivolumab 1mg/kg

Dose Level 1

DRUG

Bexmarilimab 3mg/kg and nivolumab 1mg/kg

Dose Level 2

DRUG

Recommended Phase II Dose

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

Sponsors & Collaborators

  • Faron Pharmaceuticals Ltd

    collaborator INDUSTRY

  • The Christie NHS Foundation Trust

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Dr Anna Minchom, MB BCh, FRCP, MD (Res) · Institute of Cancer Research, United Kingdom

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718243 on ClinicalTrials.gov