Actively Recruiting
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
Led by Fred Hutchinson Cancer Center · Updated on 2026-03-12
25
Participants Needed
1
Research Sites
333 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
A
Amazon, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- At least one tumor lesion suitable for tissue collection by biopsy or surgery
- Measurable disease by RECIST 1.1 criteria with lesions meeting size requirements
- Serum creatinine below 1.5 mg/dL or estimated glomerular filtration rate above 60 mL/min
- Total bilirubin less than 1.5 times ULN, AST/ALT less than 2.5 times ULN, or 5 times ULN if liver metastases present
- Grade 1 or less dyspnea and arterial oxygen saturation of 92% or higher on room air
- For patients 60 years or older, left ventricular ejection fraction of 50% or higher within 60 days prior to enrollment
- Absolute neutrophil count above 1000 cells/mm3
- Hemoglobin level of 9 mg/dL or higher
- Platelet count of 50,000/uL or higher
- Recovery from prior therapy toxicity to grade 2 or less per NCI CTCAE v5
- Willingness and ability to comply with study visits, treatments, and procedures
- Ability to provide written informed consent
- Use of effective contraception for participants who can become pregnant
- Specific tissue confirmation and treatment history requirements for melanoma, breast cancer, and non-small cell lung cancer as defined in the protocol
You will not qualify if you...
- Unwillingness or inability to use effective contraception during the study and for 5 months after last dose
- History of severe immune-related adverse events from prior cancer immunotherapy requiring permanent PD-1 inhibitor discontinuation
- Immune-related adverse events not resolved to baseline or requiring ongoing corticosteroids
- Uncontrolled tumor-related pain or recent palliative radiotherapy within 4 weeks
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
- Known symptomatic brain metastases unless treated and stable for at least 1 month
- Rapidly progressing or symptomatic visceral disease despite approved bridging therapy
- Known primary immunodeficiencies or prior bone marrow/solid organ transplantation
- Known HIV infection
- Active infection causing fever above 38.1°C or unexplained fever
- Uncontrolled infections except well-controlled hepatitis B or C
- Recent use of systemic immunosuppressive medications within 2 weeks before screening
- Abnormal coagulation parameters unless on stable anticoagulant therapy
- Other medical, social, or psychiatric conditions that interfere with study compliance
- Positive pregnancy test or lactation during study
- Receipt of live vaccine within 30 days before enrollment
- Specific exclusions for uveal melanoma, symptomatic breast cancer, and certain lung cancer genetic mutations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
F
FHCC Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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