Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer

ConditionsAnatomic Stage IV Breast Cancer AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Locally Advanced Cutaneous Melanoma Locally Advanced Mucosal Melanoma Metastatic Acral Melanoma Metastatic Conjunctival Melanoma Metastatic Cutaneous Melanoma Metastatic HER2-Negative Breast Carcinoma Metastatic Hormone Receptor-Positive Breast Carcinoma Metastatic Lung Non-Small Cell Carcinoma Metastatic Malignant Solid Neoplasm Metastatic Mucosal Melanoma Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IIID Cutaneous Melanoma AJCC v8 Recurrent Cutaneous Melanoma Recurrent HER2-Negative Breast Carcinoma Recurrent Hormone Receptor-Positive Breast Carcinoma Recurrent Lung Non-Small Cell Carcinoma Recurrent Mucosal Melanoma Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Unresectable Acral Melanoma Unresectable Cutaneous Melanoma Unresectable Lung Non-Small Cell Carcinoma Unresectable Mucosal Melanoma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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) 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as >= 10 mm, unless lymph node in which case short axis must be >= 15 mm. Baseline imaging (for example diagnostic CT chest/abdomen/pelvis, PET CT scan and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) must be obtained within 45 days of prior to start of first planned vaccine dose infusion. MRI can be substituted for CT in patients unable to have CT contrast

Disqualifiers

Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 5 months after the last dose of investigational product

Any history of an immune-related grade 4 adverse event attributed to prior cancer immunotherapy CIT (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase)

Any history of an immune-related grade 3 adverse event attributed to prior CIT that required permanent discontinuation of PD-1 inhibitor therapy

Immune-related adverse events related to prior CIT (other than endocrinopathy managed with replacement therapy or stable vitiligo) that have not resolved to baseline. Patients treated with corticosteroids for immune-related adverse events must demonstrate absence of related symptoms or signs for >= 4 weeks following discontinuation of corticosteroids

Trial design

Treatments tested in this trial

Neoantigen Peptide Vaccine
Nivolumab
Poly ICLC
Echocardiography
Multigated Acquisition Scan
Biopsy
Biospecimen Collection
Computed Tomography
Positron Emission Tomography

Treatment groups

25 Participants

are divided into 1 treatment group

Sponsors and collaborators

Fred Hutchinson Cancer Center

Lead sponsor

Amazon, Inc.

Collaborator

Source ClinicalTrials.gov