Fred Hutchinson Cancer Center
This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or does not respond to treatment (refractory) or stage III-IV non-small cell lung cancer. Personalized neo-antigen peptide vaccine is a product that combines multiple patient specific neo-antigens. Given personalized neo-antigen peptide vaccine together with Th1 polarizing adjuvant poly ICLC may induce a polyclonal, poly-epitope, cytolytic T cell immunity against the patient's tumor.
OUTLINE: Patients receive poly ICLC intramuscularly (IM) or intratumorally (IT) once weekly in weeks when no vaccine is given. Beginning 2 weeks after starting poly ICLC, patients receive personalized neo-antigen peptide vaccine IM once every 4 weeks and nivolumab intravenously (IV) every 2 or 4 weeks. Treatment continues for 25 weeks in the absence of disease progression or unacceptable toxicity. Patients determined to have clinical benefit on a first course of treatment may repeat a 6-month course of treatment as described above. Patients then receive nivolumab IV every 2 or 4 weeks for up…
Inclusion Criteria: * Female and/or male patients age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Patients must have at least 1 lesion (or aggregate lesions) to obtain tumor tissue for resection of \>= 1 cm or \>= 4 core biopsies acceptable. Amenable to image (CT, ultrasound \[U/S\], or magnetic resonance imaging \[MRI\]) guided biopsy for tissue collection necessary for neoantigen identification. Either primary or metastatic sites are options for tissue collection * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1…
Given IM
Given IV
Given IM or IT
Undergo ECHO
Undergo MUGA
Undergo tumor biopsy
Undergo blood sample collection
Undergo CT or PET/CT
Undergo PET or PET/CT
Given PO