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Bexmarilimab 1mg/kg and nivolumab 1mg/kg / Melanoma (skin Cancer) / Solid Tumor in Advanced Stage · Phase 1/2 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an active Phase 1/2 clinical trial registration testing bexmarilimab plus nivolumab in immunotherapy-refractory melanoma and non-small cell lung cancer. No results have been reported in this registry record; the study is recruiting and aims to establish a recommended Phase 2 dose in Phase 1, followed by preliminary efficacy assessment in Phase 2.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Melanoma (Skin Cancer), Non Small Cell Lung Cancer, Solid Tumor in Advanced Stage; age from 18 Years. Intervention: Phase I: Dose Escalation; Phase II: Dose Expansion. n = 62. 2 sites: United Kingdom.
This is an active Phase 1/2 clinical trial registration testing bexmarilimab plus nivolumab in immunotherapy-refractory melanoma and non-small cell lung cancer. No results have been reported in this registry record; the study is recruiting and aims to establish a recommended Phase 2 dose in Phase 1, followed by preliminary efficacy assessment in Phase 2.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This trial is not yet able to inform clinical practice. Once complete, Phase 1 findings will establish safety and tolerability; Phase 2 efficacy results in melanoma and NSCLC could support further development if the combination shows activity in immunotherapy-refractory disease.
This is a Phase 1/2 trial registration with no reported results; the study is actively recruiting and has not yet established safety, tolerability, or efficacy of the combination.
As stated by the source record.
Quoted from the source exactly as published.
This trial is not yet able to inform clinical practice. Once complete, Phase 1 findings will establish safety and tolerability; Phase 2 efficacy results in melanoma and NSCLC could support further development if the combination shows activity in immunotherapy-refractory disease.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07718243). This is a study registration, not published results. Lead sponsor: Institute of Cancer Research, United Kingdom. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 62 participants (ESTIMATED). Conditions: Melanoma (Skin Cancer), Non Small Cell Lung Cancer, Solid Tumor in Advanced Stage. Interventions: DRUG: Bexmarilimab 1mg/kg and nivolumab 1mg/kg; DRUG: Bexmarilimab 3mg/kg and nivolumab 1mg/kg; DRUG: Recommended Phase II Dose. Primary outcome measures: To establish a recommended Phase II dose (RP2D) of bexmarilimab in combination with nivolumab , 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 , 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 , From date of enrolment until the date of first documented progression, assessed up to 48 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.