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
Public ClinicalTrials.gov record NCT05098210. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer, Pre-Treated Nonsmall Cell Lung Cancer and PD1/PD-L1 Inhibitor-Refractory Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05098210
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 28 participants
Conditions and interventions
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
Interventions
- Neoantigen Peptide Vaccine Biological
- Nivolumab Biological
- Poly ICLC Drug
- Echocardiography Test Procedure
- Multigated Acquisition Scan Procedure
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Positron Emission Tomography Procedure
- Ruxolitinib Drug
Biological · Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 8, 2022
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2028
- Last update posted
- Jul 21, 2026
2022 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05098210, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 21, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05098210 live on ClinicalTrials.gov.