A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma

Exclusion Criteria

• •Patients who have had cytotoxic chemotherapy, radiotherapy, interferon (IFN), or ipilimumab before entering the study
• •Immunosuppressive therapy within 30 days prior to initiation of protocol therapy
• •Steroid therapy, or steroid therapy with more than 7 consecutive days of steroids within the prior 4 weeks
• •* The use of prednisone or equivalent \< 0.125 mg/kg/day (absolute maximum of 10 mg/day) as replacement therapy is permitted
• •* Inhaled or topical corticosteroids are permitted
• •Patients who are receiving any other investigational agents
• •Current or history of systemic autoimmune disease requiring systemic therapy.
• •* NOTE: The following will not be exclusionary:
• •* The presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody \[ANA\] titer) without associated symptoms
• •* Clinical evidence of vitiligo
• •* Other forms of depigmenting illness
• •Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association Class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
• •Cirrhosis or chronic hepatitis C virus positivity or chronic hepatitis B infection
• •* NOTE: A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B virus surface antibody \[HBsAb\]-positive and hepatitis B virus core antibody \[HBcAb\]-negative), or a fully resolved acute hepatitis B virus infection is not an exclusion criterion
• •Known history of immunodeficiency disorder other than HIV-positive status
• •Extensive active brain disease including symptomatic brain metastases or presence of leptomeningeal disease
• •* NOTE: Patients with brain metastasis, after definitive therapy with surgery or stereotactic radiation and stable off steroids for \>= 4 weeks, are eligible
• •Other invasive cancers that are clinically active
• •Pregnancy or nursing or unwilling to take adequate birth control during therapy
• •* NOTE: Pregnant women are excluded from this study because CDX-1401 or CDX-301 and poly-ICLC have an unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CDX-1401 or CDX-301, breastfeeding should be discontinued if the mother is treated with CDX-1401 or CDX-301 and poly-ICLC
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-1401 or CDX-301 or poly-ICLC
• •Prior organ allograft or allogeneic transplantation, if the transplanted tissue is still in place
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves
• •History of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD) (forced expiratory volume in 1 second \[FEV1\] \< 60% of predicted for height and age). Pulmonary function tests (PFTs) are required in patients with prolonged smoking history or symptoms of respiratory dysfunction
• •Vaccinations other than those given as part of this research study (with the exception of influenza vaccine) are prohibited throughout the duration of study participation.
• •* NOTE: Influenza vaccination (inactivated) is permitted during the flu season. The preferred time is 7 to 14 days after CDX-1401 administration