OncoMatch/Clinical Trials/NCT07718243
Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC
Is NCT07718243 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including Bexmarilimab 1mg/kg and nivolumab 1mg/kg and Bexmarilimab 3mg/kg and nivolumab 1mg/kg for melanoma (skin cancer).
Treatment: Bexmarilimab 1mg/kg and nivolumab 1mg/kg · Bexmarilimab 3mg/kg and nivolumab 1mg/kg · Recommended Phase II Dose — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Melanoma
Non-Small Cell Lung Carcinoma
Tumor Agnostic
Biomarker criteria
Allowed: ALK actionable genomic alteration
Allowed: BRAF mutation
Allowed: EGFR actionable genomic alteration
Disease stage
Metastatic disease required
Performance status
WHO 0–1
Prior therapy
Must have received: systemic anticancer therapy — metastatic disease
Patient has received at least one but not more than three lines of systemic anticancer therapy for metastatic disease.
Must have received: immune checkpoint inhibitor
Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose.
Must have received: targeted therapy
Patients with actionable EGFR, ALK, or other known genomic alterations must have received at least 1 relevant targeted therapy treatment if available.
Must have received: targeted therapy
Patients with BRAF mutations must have received relevant targeted therapy.
Cannot have received: bone marrow transplant
Prior bone marrow transplant
Cannot have received: allogenic tissue/solid organ transplant
allogenic tissue/solid organ transplant
Lab requirements
Blood counts
Haemoglobin (Hb) ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L
Kidney function
Glomerular filtration rate ≥ 30 mL/min (uncorrected value)
Liver function
Serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease); ALT ≤ 2.5 x ULN (≤ 5 x ULN if due to tumour); AST ≤ 2.5 x ULN (≤ 5 x ULN if due to tumour)
Cardiac function
Mean resting QTc > 470 msec (exclusion); known congenital QT syndrome or history of torsades de pointes; significant ECG abnormalities; recent major cardiac events or NYHA Grade 2+ heart failure
Laboratory Test Value required Haemoglobin (Hb) ≥ 9.0 g/dL Absolute neutrophil count ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L Serum bilirubin ≤ 1.5 x ULN; with the following exception: Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled ALT ≤ 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible AST ≤ 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible Renal function Calculated creatinine clearance (using the Wright, Cockcroft & Gault formula) Glomerular filtration rate ≥ 30 mL/min (uncorrected value)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07718243 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bone marrow transplant, allogenic tissue/solid organ transplant disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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