Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Cancer Research, United Kingdom
About this trial
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.
Eligibility criteria
Qualifiers
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.
Patients with actionable EGFR, ALK, or other known genomic alterations must have received at least 1 relevant targeted therapy treatment if available.
Disqualifiers
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.
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
Trial design
Treatments tested in this trial
- Bexmarilimab 1mg/kg and nivolumab 1mg/kg
- Bexmarilimab 3mg/kg and nivolumab 1mg/kg
- Recommended Phase II Dose
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Institute of Cancer Research, United Kingdom
Lead sponsor
Faron Pharmaceuticals Ltd
Collaborator
The Christie NHS Foundation Trust
Collaborator
Royal Marsden NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov