NCT05098210 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
| NCT ID | NCT05098210 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Fred Hutchinson Cancer Center |
| Condition | Anatomic Stage IV Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-06-09 |
| Primary Completion | 2027-11-01 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: * 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 (MR
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