MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma

Exclusion Criteria

• •Active secondary malignancy
• •Prior systematic treatment with radioactive nuclides. Subjects who had localized treatment with radioactive nuclides or imaging using radioactive imaging agents may be enrolled
• •Pregnancy or breastfeeding a child
• •Any serious/active/uncontrolled infection requiring parenteral antibiotics within 2 weeks before the first administration of \[212Pb\]VMT01
• •Febrile illness within 48 hours of any scheduled investigational product (\[212Pb\]VMT01, \[203Pb\]VMT01, or \[68Ga\]VMT02) administration; subjects should be rescheduled \> 48 hours after resolution of fever
• •Treatment with another investigational drug product (therapeutic IND agents) within the last 45 days before the first dose of \[212Pb\]VMT01 on C1D1.
• •Current abuse of alcohol or illicit drugs
• •Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions
• •Untreated central nervous system (CNS) metastasis or metastasis requiring acute therapy of any modality. Subjects must have been either off corticosteroids, or on a stable or decreasing dose of prednisone (or equivalent) for at least 2 weeks prior to the first dose of \[212Pb\]VMT01
• •Subjects with an active, known, or suspected autoimmune disease
• •Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
• •Acute or chronic hepatitis B (e.g., Hepatitis B surface antigen reactive), hepatitis C (e.g., HCV RNA \[qualitative\] is detected) or known history of Human Immunodeficiency Virus (HIV) with an acquired immunodeficiency syndrome
• •Treatment with complementary medications (e.g., herbal supplements or traditional Chinese medicines)
• •Existence of abnormal laboratory values in hematology, liver, and renal function
• •Treatment with any live/attenuated vaccine within 30 days prior to the first dose of \[212Pb\]VMT01
• •Any treatment-related toxicities from prior systemic immune therapy with the exception of those unlikely to re-occur with standard countermeasures
• •History of allergy or hypersensitivity to nivolumab or its components