SCIB1 and iSCIB1+ in Melanoma Patients Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

Exclusion Criteria

• •1. A diagnosis of mucosal, acral or ocular melanoma.
• •2. Has central nervous system metastases or carcinomatous meningitis.
• •3. Has previously received a treatment to block cytotoxic T lymphocyte associated protein 4 (CTLA-4), programmed cell death protein 1 (PD-1), PD-L1, or programmed death-ligand 2 (PD-L2) with the following exception: patients who have received neoadjuvant or adjuvant treatment with these treatments are eligible, provided that the last dose was administered at least 24 weeks before the first dose of SCIB1 or iSCIB1+.
• •4. Patients with lactate dehydrogenase (LDH) \> 2 x ULN.
• •5. Expected to require any other form of systemic or localized anticancer therapy while receiving study treatment.
• •6. Taking any systemic steroid therapy within 1 week of the first dose of study drug or is receiving any other form of immune suppressant medication. Physiological doses of systemic steroids such as those for the management of adrenal insufficiency, as well as topical and inhaled steroids, such as those for the management of asthma, are permitted.
• •7. Receiving treatment with any investigational product within 28 days (or 5 half-lives of the treatment concerned) prior to the first dose of study treatment.
• •8. Has a previous (within 5 years) or current malignancy with the exception of melanoma, and curatively treated local tumours.
• •9. Has a concurrent illness which would preclude study conduct and assessment.
• •10. Has New York Heart Association class III or IV heart disease, myocardial infarction within previous 6 months, a heart rate of ≤ 50 beats per minute, a history of significant cardiac abnormality and/or clinically significant abnormal baseline ECG reading, active ischemia, or any other uncontrolled cardiac condition.
• •11. Has a history of severe hypersensitivity reaction to treatment with a monoclonal antibody.
• •12. Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents (patients with vitiligo or resolved childhood asthma/atopy are an exception and are not excluded for these conditions). The following patients are not excluded from the study: patients who require intermittent use of bronchodilators or local steroid injections, patients with hypothyroidism stable on hormone replacement, and patients who receive physiological doses of steroids as replacement therapy, such as those for the management of adrenal insufficiency. In such cases the recruiting investigator should discuss the patients' eligibility with the study Medical Monitor prior to enrolment.
• •13. Received a live vaccine within the 28 days prior to first dose of study treatment, or patient has received a non-live vaccine, including COVID-19 vaccines, within 14 days prior to first dose of study treatment.
• •14. A known history of human immunodeficiency virus (HIV) or has any positive test for hepatitis B virus or hepatitis C virus indicating active acute or chronic infection.
• •15. A known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.