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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT05098210
Phase
PHASE1
Status
Recruiting
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Conditions

  • Anatomic 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neoantigen Peptide Vaccine — BIOLOGICAL
    Given IM
  • Nivolumab — BIOLOGICAL
    Given IV
  • Poly ICLC — DRUG
    Given IM
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Biopsy — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET or PET/CT

Study Details

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.

Key Dates

Start date
Jun 9, 2022
Status verified
Mar 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (poly ICLC, neo-antigen peptide vaccine, nivolumab)
    Patients receive poly ICLC IM 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 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 to 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients may undergo ECHO or MUGA during screening. Patients also undergo tumor biopsy, blood sample collection, and CT and/or PET throughout the study.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: 1 year post first vaccination ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
FHCC Intake
[email protected]
206-606-1024
Joshua Veatch (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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