ClinicalTrials.gg
RecruitingNCT07718243BLAZEUpdated Sep 8, 2026

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

A Phase 1/2 interventional study of Bexmarilimab 1mg/kg and nivolumab 1mg/kg and Bexmarilimab 3mg/kg and nivolumab 1mg/kg in Melanoma (Skin Cancer), Non Small Cell Lung Cancer and Solid Tumor in Advanced Stage, sponsored by Institute of Cancer Research, United Kingdom. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Institute of Cancer Research, United Kingdom · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
62
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Melanoma (Skin Cancer)
  • Non Small Cell Lung Cancer
  • Solid Tumor in Advanced Stage
03

In context

Melanoma

3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.

This study's planned enrollment of 62 is above the median of 40 across 2,649 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Institute of Cancer Research, United Kingdom is the lead sponsor of 113 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Part A:

    proven solid tumour, to conventional treatment, or for which no conventional therapy exists or is declined by the patient

    Part B1: Histologically proven NSCLC.

    • Patient has received at least one but not more than three lines of systemic anticancer therapy for disease.
    • Patient has received at least two cycles of and has demonstrated disease progression within 12 weeks of last dose.
    • Patient has had a benefit to prior immune checkpoint inhibitor defined as greater than 6 months of treatment or partial response.
    • Patients with actionable EGFR, ALK, or other known genomic alterations must have received at least 1 relevant targeted therapy treatment if available.

    Part B2: Histologically proven cutaneous melanoma.

    • Patient has received at least one but not more than three lines of systemic anticancer therapy for metastatic disease.
    • Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose.
    • Patients with BRAF mutations must have received relevant targeted therapy.
    • Patient has had a benefit to prior immune checkpoint inhibitor defined as greater than 6 months of treatment or partial response
  2. of at least 12 weeks
  3. World Health Organisation (WHO) performance status of 0-1 (Appendix 2)
  4. as assessed by
  5. Biologically female patients are eligible to participate in the trial if they are not pregnant, not breast feeding and meet one of the following criteria:

    1. a biological woman of (WOCB) who has a negative serum or urine pregnancy test before enrolment and agrees to use a highly effective form of (refer to Appendix 3) from signing the consent form, throughout the trial and for six months afterwards. A biological woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
    2. A biological woman of non-childbearing potential; a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in biological women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
  6. Biologically male patients are eligible to participate in the trial if they meet one of the following criteria:

    1. is fertile and agrees to use and ensure their partners (if WOCBP) use a highly effective form of contraception (refer to Appendix 3) from signing the consent form, throughout the trial and for six months afterwards. Biological men with pregnant or lactating partners must be advised to use barrier method contraception (refer to Appendix 3) to prevent exposure of the foetus or neonate; a biological man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy
    2. is infertile
  7. Negative serology for (HIV), virus (HBV), and virus (HCV)
  8. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP

    Laboratory Test Value required (Hb) ≥ 9.0 g/dL ≥ 1.5 x 109/L count ≥ 100 x 109/L

    Serum ≤ 1.5 x ; with the following exception:

    Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled

    ≤ 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 (using the Wright, Cockcroft \& Gault formula) ≥ 30 mL/min (uncorrected value)

  9. 18 years or over
  10. Written (signed and dated) and be capable of co-operating with treatment and follow-up

Exclusion criteria

Exclusion Criteria:

  1. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and 4 weeks for medicinal products) before treatment.
  2. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia/vitiligo, treated endocrinopathies (i.e. on physiological doses of endocrine replacement) or certain Grade 1 toxicities, which in the opinion of the Investigator and the CI should not exclude the patient.
  3. Known untreated or active central nervous system (CNS) (progressing or requiring for symptomatic control). Patients with a history of treated are eligible, provided they meet all of the following criteria:

    • Evaluable or outside the CNS is present.
    • Radiographic stability upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the baseline disease assessment
    • Not requiring corticosteroids.
  4. Major thoracic or abdominal surgery from which the patient has not yet recovered.
  5. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
  6. Known to be serologically positive for , or .
  7. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of therapy within 14 days prior to the first dose of trial treatment
  8. Has an active disease that has required systemic treatment in past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or is at risk of recurrence. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with a history of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis will be excluded from the study. Patients with Sjogren's syndrome will not be excluded from the study.
  9. Are receiving chronic systemic steroids (> 10 mg/day prednisone equivalent). Use of topical, inhalational, intranasal, and intraocular steroids will be permitted.
  10. Patients that experienced a Grade 3 or higher immune-related AEs from prior treatment with immunotherapy will be excluded from the study.
  11. Has received a within 30 days of planned start of study therapy. Note: The inactivated virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.
  12. Any of the following cardiac criteria:

    • Mean resting interval (QTc) > 470 msec obtained from 3 consecutive (ECGs) within 5 minutes of each other.
    • Known congenital QT syndrome or history of torsades de pointes. Any abnormalities in rhythm, conduction or morphology of resting ECG, e.g. complete left bundle branch block, third degree heart block. Controlled atrial fibrillation is allowed.
    • Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure [NYHA Grade 2 or above], severe valvular disease, uncontrolled hypertension despite optimal therapy.
  13. Prior bone marrow transplant, allogenic tissue/solid organ transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks.
  14. Current of other types, with the exception of adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. An exception to this criteria are cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
  15. Is a patient or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.
  16. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
  17. Symptoms of COVID-19 and/or documented COVID-19 infection
  18. to the active substance or to any of the IMP
  19. Active or known pre-existing or history of non-infectious/interstitial lung disease/pneumonitis
Terms in these criteria, in plain language(35)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

iRECIST and mRECIST

Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Phase I: Dose Escalation

    Phase I will establish a recommended Phase 2 dose (RP2D) of Bexmarilimab in combination with Nivolumab

    Drug: Bexmarilimab 1mg/kg and nivolumab 1mg/kg · Drug: Bexmarilimab 3mg/kg and nivolumab 1mg/kg

  • Experimental
    Phase II: Dose Expansion

    Phase II will assess the anti-tumour activity of bexmarilimab in combination with nivolumab

    Drug: Recommended Phase II Dose

Interventions

  • DrugBexmarilimab 1mg/kg and nivolumab 1mg/kg

    Drug page: Bexmarilimab

    Dose Level 1

  • DrugBexmarilimab 3mg/kg and nivolumab 1mg/kg

    Drug page: Bexmarilimab

    Dose Level 2

  • DrugRecommended Phase II Dose

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

This study also gives Nivolumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. 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)".

  2. Determining causality of each adverse event to bexmarilimab and nivolumab and grading severity according to the NCI CTCAE Version 5.0

    Time frame: From the start of treatment until the end of the trial (due to documented disease progression or withdrawal of consent or toxicity), with follow-up continuing for 28 days after the last dose of the IMP.

  3. Evaluation of disease response by RECIST criteria version 1.1, immune-modified RECIST (iRECIST) and thus overall response rate

    Time frame: From date of enrolment until the date of first documented progression, assessed up to 48 months

Secondary outcomes

  1. Evaluation of disease response by RECIST criteria version 1.1, iRECIST and thus response rate, clinical benefit rate, radiological PFS and overall survival.

    Time frame: From date of enrolment until the date of first documented progression, assessed up to 48 months

  2. Determination of changes in markers of target inhibition and immune microenvironment in tumour and blood.

    Time frame: 48 months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jan 2030, 41 months after the start.

Of 85 non-industry phase 1/2 interventional studies under Melanoma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 47 and three quarters within 98. This study's planned 41 months is below that.

Counting every sponsor, half of 220 studies reached it within 61 months; a quarter within 42 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2026
First posted
Jul 21, 2026
StartActual
Aug 28, 2026
Primary completionEst.
Jan 31, 2030
CompletionEst.
Jan 31, 2030
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07718243
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Aug 28, 2026
Primary completion
Jan 31, 2030 (estimated)
Completion
Jan 31, 2030 (estimated)
Last update
Sep 8, 2026

Study contacts

Aasia Hussain, PhD
Contact
BLAZE@icr.ac.uk
02034376301
Anna Zachariou, PhD
Contact
BLAZE@icr.ac.uk
Dr Anna Minchom, MB BCh, FRCP, MD (Res)
study director · Institute of Cancer Research, United Kingdom

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Bexmarilimab

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