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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 v8Clinical Stage IV Cutaneous Melanoma AJCC v8Locally Advanced Cutaneous MelanomaLocally Advanced Mucosal MelanomaMetastatic Acral MelanomaMetastatic Conjunctival MelanomaMetastatic Cutaneous MelanomaMetastatic HER2-Negative Breast CarcinomaMetastatic Hormone Receptor-Positive Breast CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic Mucosal MelanomaPathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Recurrent Cutaneous MelanomaRecurrent HER2-Negative Breast CarcinomaRecurrent Hormone Receptor-Positive Breast CarcinomaRecurrent Lung Non-Small Cell CarcinomaRecurrent Mucosal MelanomaStage III Lung Cancer AJCC v8Stage IV Lung Cancer AJCC v8Unresectable Acral MelanomaUnresectable Cutaneous MelanomaUnresectable Lung Non-Small Cell CarcinomaUnresectable 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Neoantigen Peptide Vaccine

    Biological/Vaccine

    Given IM

  • Nivolumab

    Biological/Vaccine

    Given IV

  • Poly ICLC

    Drug

    Given IM or IT

  • Echocardiography Test

    Procedure/Surgery

    Undergo ECHO

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tumor biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET or PET/CT

  • Ruxolitinib

    Drug

    Given PO

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Treatment (poly ICLC, neo-antigen peptide vaccine, nivolumab)Experimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Will be assessed by Common Terminology Criteria for Adverse Events version 5.0.

Time frame
1 year post first vaccination

Secondary outcomes

1

Number of formulated and administered personalized neo-antigen vaccines

Time frame
Week 48
2

Number of formulated personalized neo-antigen vaccines with at least five (5) vaccine peptides

Time frame
Week 48
3

Number of formulated personalized neo-antigen vaccines in less than 16 weeks since screening visit biopsy

Time frame
16 weeks
4

Evaluation of target lesion

By Response Evaluation Criteria In Solid Tumors (RECIST) and Immune-Modified RECIST criteria.

Time frame
At 1 year post first vaccination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

Amazon, Inc.

Collaborator

Source ClinicalTrials.gov
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