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

Exclusion criteria

• . 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.
• . 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.