Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma

Exclusion Criteria

• •1. The following medications or treatments at any time within 4 weeks of registration:
• •* Chemotherapy
• •* Interferon (e.g. Intron-A®)
• •* Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week and ≤ 6 months prior to registration)
• •* Allergy desensitization injections
• •* High doses of systemic corticosteroids
• •* Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
• •* Interleukins (e.g. Proleukin®)
• •* Any investigational medication
• •* Targeted therapies specific for mutated BRAF or for MEK
• •2. Nitrosoureas within 6 weeks of registration.
• •3. Checkpoint molecule blockade therapy within 12 weeks of registration.
• •4. Known or suspected allergies to any component of the vaccine.
• •5. Previous vaccination with 6MHP.
• •6. Prior treatment with CDX-1127 or other CD27 agonistic antibody.
• •7. Pregnancy.
• •8. HIV positivity or evidence of active Hepatitis C virus.
• •9. Female participants must not be breastfeeding.
• •10. A medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
• •11. New York Heart Association classification as having Class III or IV heart disease.
• •12. Uncontrolled diabetes, defined as having an HgbA1c \> 8.5%.
• •13. Prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded.
• •14. Participants with known addiction to alcohol or drugs who are actively taking those agents, or participants with recent (within 1 year) or ongoing illicit IV drug use.
• •15. Participants who have received a live vaccine within 30 days of registration.
• •16. Body weight \< 110 pounds at registration, due to the amount and frequency with which blood will be drawn.
• •17. Participants with prior autoimmune pneumonitis.