Actively Recruiting
Personalized Neo-Antigen Peptide Vaccine for Stage IIIC-IV Melanoma, Metastatic Hormone Receptor Positive HER2 Negative Breast Cancer, and Stage III-IV Non-Small Cell Lung Cancer Phase I Study
Led by Fred Hutchinson Cancer Center ยท Updated on 2026-03-12
25
Participants Needed
1
Research Sites
52 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
Researchers are evaluating a personalized neo-antigen peptide vaccine combined with the Th1 polarizing adjuvant poly ICLC to study its safety in treating patients with advanced melanoma, hormone receptor-positive HER2-negative metastatic or refractory breast cancer, and stage III-IV non-small cell lung cancer. This phase I trial aims to induce a targeted immune response against tumors by combining multiple patient-specific neo-antigens. Patients receive poly ICLC intramuscularly once weekly during weeks without vaccine administration. Starting two weeks after beginning poly ICLC, patients receive the personalized neo-antigen peptide vaccine intramuscularly every four weeks along with nivolumab intravenously every two or four weeks. Treatment continues for 25 weeks unless disease progresses or unacceptable toxicity occurs. Patients showing clinical benefit may repeat a six-month treatment course, followed by nivolumab monotherapy for up to 12 months under similar conditions. Screening may include echocardiography or multigated acquisition scans, and biopsies, blood collection, and imaging (CT or PET) occur throughout the study. Participants undergo assessments including tumor biopsies, blood tests, and imaging scans during the study. Follow-up visits occur at 24, 36, and 48 weeks after treatment completion, with an additional 12 months of monitoring for patients continuing nivolumab or off treatment without disease progression. Researchers track adverse events, vaccine formulation, tumor response, and progression-free survival to evaluate treatment safety and effects over time.
CONDITIONS
Brief 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
- ECOG performance status of 0, 1, or 2
- At least one lesion measurable and suitable for biopsy of 1 cm or 4 core biopsies
- Measurable disease by RECIST 1.1 criteria with target lesion size meeting specified dimensions
- Adequate kidney, liver, and lung function based on lab tests
- Patients 60 or older must have left ventricular ejection fraction of 50% or higher
- Hematologic requirements: ANC > 1000 cells/mm3, hemoglobin >= 9 mg/dL, platelet count >= 50,000/uL
- Recovery from prior therapy toxicities to grade 2 or less
- Ability and willingness to comply with study procedures and provide informed consent
- Use of effective contraception if capable of pregnancy
- Specific tissue confirmation and prior treatment lines for melanoma, breast cancer, and non-small cell lung cancer as detailed in protocol
You will not qualify if you...
- Unwillingness or inability to use two effective contraception methods during and after the study
- History of severe immune-related adverse events from prior immunotherapy
- Unresolved immune-related adverse events or recent corticosteroid use
- Uncontrolled tumor-related pain or effusions requiring frequent drainage
- Symptomatic brain metastases or unstable neurologic status
- Rapidly progressing or symptomatic visceral disease
- Known primary immunodeficiencies or prior organ transplantation
- Positive HIV test or active uncontrolled infections
- Recent live vaccine administration
- History of autoimmune diseases not controlled in the past year with exceptions
- Recent use of systemic immunosuppressive medications
- Abnormal coagulation parameters unless on stable anticoagulant therapy
- Other medical or psychiatric conditions interfering with study participation
- Pregnant or breastfeeding women
- Specific exclusions for melanoma type, breast cancer symptoms, and lung cancer mutations as detailed in protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial. This may include echocardiography (ECHO) or multigated acquisition scan (MUGA), tumor biopsy, blood sample collection, and imaging such as CT or PET scans.
1 to 2 visits depending on assessments
Duration - Up to 25 weeks initially, with possible additional 6-month treatment course
Participants receive poly ICLC intramuscularly (IM) once weekly during weeks without vaccine administration. Starting 2 weeks after beginning poly ICLC, participants 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 side effects. Those who benefit may repeat a 6-month course of treatment similarly. Participants also undergo tumor biopsy, blood sample collection, and CT and/or PET imaging during this period.
Weekly injections of poly ICLC during non-vaccine weeks, vaccine every 4 weeks, nivolumab every 2 or 4 weeks, additional visits for biopsies and imaging
Duration - Up to 12 months post-treatment with additional follow-up up to 12 months
After completing treatment, participants receive nivolumab IV every 2 or 4 weeks for up to 12 months if no disease progression or unacceptable toxicity occurs. Participants are followed up at 24, 36, and 48 weeks after treatment completion and may continue post-treatment follow-up for an additional 12 months if continuing nivolumab or off treatment.
Nivolumab IV every 2 or 4 weeks, follow-up visits at 24, 36, and 48 weeks post-treatment, with possible additional visits
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
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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