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

Sponsor
Institute of Cancer Research, United Kingdom
Study ID
NCT07718243
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
62 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Dose Escalation
    Phase I will establish a recommended Phase 2 dose (RP2D) of Bexmarilimab in combination with Nivolumab
  • Experimental: Phase II: Dose Expansion
    Phase II will assess the anti-tumour activity of bexmarilimab in combination with nivolumab

Primary Outcome Measure

To establish a recommended Phase II dose (RP2D) of bexmarilimab in combination with nivolumab [ Time Frame: At the end of Cycle 2 (Cycle 1 is 28 days and Cycle 2 is 21 days)". ]

Central Contacts

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