CMP-001 in Combo With Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease

Inclusion Criteria

• Be willing and able to provide written informed consent for the study.
• Be ≥ 18 years of age on day of signing informed consent.
• Diagnosis of histologically or cytologically confirmed diagnosis of cutaneous melanoma belonging to one of the following AJCC TNM stages:
• Tx or T1-4 and
• N1b, or N1c, or N2b, or N2c, or N3b, or N3c and
• M0

Patients are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal and/or in-transit metastasis; or at the time of clinical detected nodal and/or in-transit recurrence; and may belong to any of the following groups:

• Primary cutaneous melanoma with clinically apparent regional lymph node metastases.
• Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin.
• Clinically detected primary cutaneous melanoma involving multiple regional nodal groups.
• Clinical detected nodal melanoma (if single site) arising from an unknown primary.
• In-transit and/or satellite metastases with or without regional lymph node involved permitted if considered potentially surgically resectable at baseline.
• NOTE: Determination of potential resectability must be made at baseline to be eligible for this neoadjuvant study.
• NOTE: Patients with mucosal and/or uveal melanoma are not permitted to enroll. Patients with melanomas of unknown primary may be enrolled at the discretion of the treating investigator in discussion with Principal Investigator.
• Presence of injectable and measureable disease based on RECIST 1.1.
• Willing to undergo tumor biopsy (core, punch, incisional or excisional). Patients must undergo biopsy (core, punch) or open biopsy (incisional, excisional) within 4 weeks of registration on the study.
• Performance status of 0 or 1 on the ECOG Performance Scale.
• Demonstrate adequate organ function as defined below performed on screening labs obtained within 4 weeks of registration.
• Absolute neutrophil count (ANC) ≥1,500 /mcL
• Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
• Platelets ≥100,000 / mcL
• Serum creatinine or Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN.
• Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN.
• AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN.
• International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
• Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 26 weeks after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
• Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 26 weeks after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Exclusion Criteria

• History of uveal or mucosal melanoma.
• Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose