Melanoma (Skin Cancer)Phase 1/2BLAZENCT07718243
Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC
A Phase 1/2 study testing Bexmarilimab 1mg/kg and nivolumab 1mg/kg, Bexmarilimab 3mg/kg and nivolumab 1mg/kg and Recommended Phase II Dose in people with Melanoma (Skin Cancer) and Non Small Cell Lung Cancer, run by Institute of Cancer Research, United Kingdom at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer), Non Small Cell Lung Cancer, Solid Tumor in Advanced Stage
- What is being tested?
- Bexmarilimab 1mg/kg and nivolumab 1mg/kg, Bexmarilimab 3mg/kg and nivolumab 1mg/kg and Recommended Phase II Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 28 Aug 2026to 31 Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part A:
- Histologically proven solid tumour, refractory 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 metastatic disease.
- Patient has received at least two cycles of immune checkpoint inhibitor 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.
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- 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
- Life expectancy of at least 12 weeks
- World Health Organisation (WHO) performance status of 0-1 (Appendix 2)
- Measurable disease as assessed by iRECIST
- 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:
- a biological woman of childbearing potential (WOCB) who has a negative serum or urine pregnancy test before enrolment and agrees to use a highly effective form of contraception (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 post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- 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.
- Biologically male patients are eligible to participate in the trial if they meet one of the following criteria:
- 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
- is infertile
- Negative serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)
- 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 Haemoglobin (Hb) ≥ 9.0 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/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)
- 18 years or over
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
Who cannot join
- 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 investigational medicinal products) before treatment.
- 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.
- Known untreated or active central nervous system (CNS) metastases (progressing or requiring corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
- Evaluable or measurable disease 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.
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- Major thoracic or abdominal surgery from which the patient has not yet recovered.
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment
- Has an active autoimmune 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.
- Are receiving chronic systemic steroids (> 10 mg/day prednisone equivalent). Use of topical, inhalational, intranasal, and intraocular steroids will be permitted.
- Patients that experienced a Grade 3 or higher immune-related AEs from prior treatment with immunotherapy will be excluded from the study.
- Has received a live vaccine 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.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive electrocardiograms (ECGs) within 5 minutes of each other.
- Known congenital QT syndrome or history of torsades de pointes. Any clinically significant 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 New York Heart Association [NYHA Grade 2 or above], severe valvular disease, uncontrolled hypertension despite optimal therapy.
- Prior bone marrow transplant, allogenic tissue/solid organ transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks.
- Current malignancies 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.
- 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.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
- Symptoms of COVID-19 and/or documented COVID-19 infection
- Hypersensitivity to the active substance or to any of the IMP excipients
- Active or known pre-existing or history of non-infectious/interstitial lung disease/pneumonitis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Zachariou, PhD contact
United Kingdom2 sites, 2 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Dr Rachel Woodford, 01619182473, rachel.woodford1@nhs.net
Dr Rachel Woodford
- Recruiting
The Royal Marsden NHS Foundation Trust - Drug Development Unit
Sutton, SM2 5PT
Dr Anna Minchom, 02086426011, anna.minchom@icr.ac.uk
Dr Anna Minchom
About this study
Official title: A Phase I/II Trial of Bexmarilimab and Nivolumab in Patients With Solid Tumours, Non-Small Cell Lung Cancer and Melanoma
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.
- Being tested
- Bexmarilimab 1mg/kg and nivolumab 1mg/kg, Bexmarilimab 3mg/kg and nivolumab 1mg/kg, Recommended Phase II Dose
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bexmarilimab 1mg/kg and nivolumab 1mg/kgDrug
Dose Level 1
Bexmarilimab 3mg/kg and nivolumab 1mg/kgDrug
Dose Level 2
Recommended Phase II DoseDrug
Recommended Phase II Dose of bexmarilimab in combination with nivolumab established from Dose Escalation
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Escalation | Experimental | Phase I will establish a recommended Phase 2 dose (RP2D) of Bexmarilimab in combination with Nivolumab Receives: Drug: Bexmarilimab 1mg/kg and nivolumab 1mg/kg; Drug: Bexmarilimab 3mg/kg and nivolumab 1mg/kg |
| Phase II: Dose Expansion | Experimental | Phase II will assess the anti-tumour activity of bexmarilimab in combination with nivolumab Receives: Drug: Recommended Phase II Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a recommended Phase II dose (RP2D) of bexmarilimab in combination with nivolumab
Measured: At the end of Cycle 2 (Cycle 1 is 28 days and Cycle 2 is 21 days)".
Determining causality of each adverse event to bexmarilimab and nivolumab and grading severity according to the NCI CTCAE Version 5.0
Measured: 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.
Evaluation of disease response by RECIST criteria version 1.1, immune-modified RECIST (iRECIST) and thus overall response rate
Measured: From date of enrolment until the date of first documented progression, assessed up to 48 months
Secondary outcomes (2)
Evaluation of disease response by RECIST criteria version 1.1, iRECIST and thus response rate, clinical benefit rate, radiological PFS and overall survival.
Measured: From date of enrolment until the date of first documented progression, assessed up to 48 months
Determination of changes in markers of target inhibition and immune microenvironment in tumour and blood.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start28 Aug 2026
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Faron Pharmaceuticals Ltd, The Christie NHS Foundation Trust, Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Dr Anna Minchom, MB BCh, FRCP, MD (Res), Study director, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718243
- Sponsor's protocol ID
- CCR6142
- Acronym
- BLAZE
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Bexmarilimab and Nivolumab in Patients With Solid Tumours, Non-Small Cell Lung Cancer and Melanoma
- ClinicalTrials.gov ID
- NCT07718243
- Acronym / sponsor ID
- BLAZE / CCR6142
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Faron Pharmaceuticals Ltd, The Christie NHS Foundation Trust, Royal Marsden NHS Foundation Trust
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose Escalation | Experimental | Drug: Bexmarilimab 1mg/kg and nivolumab 1mg/kg, Drug: Bexmarilimab 3mg/kg and nivolumab 1mg/kgPhase I will establish a recommended Phase 2 dose (RP2D) of Bexmarilimab in combination with Nivolumab |
| Phase II: Dose Expansion | Experimental | Drug: Recommended Phase II DosePhase II will assess the anti-tumour activity of bexmarilimab in combination with nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Part A:
- Histologically proven solid tumour, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient
- Part B1: Histologically proven NSCLC.
- Part B2: Histologically proven cutaneous melanoma.
- Life expectancy of at least 12 weeks
Key exclusion criteria (25 listed)
- 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 investigational medicinal products) before treatment.
- 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.
- Known untreated or active central nervous system (CNS) metastases (progressing or requiring corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
- Major thoracic or abdominal surgery from which the patient has not yet recovered.
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bexmarilimab 1mg/kg and nivolumab 1mg/kgDose Level 1 | Drug | Phase I: Dose Escalation |
| Bexmarilimab 3mg/kg and nivolumab 1mg/kgDose Level 2 | Drug | Phase I: Dose Escalation |
| Recommended Phase II DoseRecommended Phase II Dose of bexmarilimab in combination with nivolumab established from Dose Escalation | Drug | Phase II: Dose Expansion |
Primary outcome
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)".
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.
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
2 secondary outcomes
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
Determination of changes in markers of target inhibition and immune microenvironment in tumour and blood.
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Zachariou, PhD contact
Dr Anna Minchom, MB BCh, FRCP, MD (Res) study director
Institute of Cancer Research, United Kingdom
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bexmarilimab 1mg/kg and nivolumab 1mg/kg, Bexmarilimab 3mg/kg and nivolumab 1mg/kg and Recommended Phase II Dose in people with Melanoma (Skin Cancer) and Non Small Cell Lung Cancer, run by Institute of Cancer Research, United Kingdom at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aasia Hussain, PhD (02034376301, BLAZE@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)".). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.