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

ConditionsMelanoma (Skin Cancer)Non Small Cell Lung CancerSolid Tumor in Advanced Stage
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Bexmarilimab 1mg/kg and nivolumab 1mg/kg

    Drug

    Dose Level 1

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

    Drug

    Dose Level 2

  • Recommended Phase II Dose

    Drug

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

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Phase I: Dose EscalationExperimental treatment 2 interventions
Group B: Phase II: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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