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NCT05098210 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05098210 is a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 25 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05098210, a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- PROCEDURE Echocardiography
- DRUG Poly ICLC
- PROCEDURE Multigated Acquisition Scan
- BIOLOGICAL Neoantigen Peptide Vaccine
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2028-11-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05098210
The ClinicalTrials.gov registry entry for NCT05098210 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (85% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Nivolumab is the first listed.
NCT05098210 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT05098210 about?
NCT05098210 is a clinical study titled "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". 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 re...
What is the current status of trial NCT05098210?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-06-09. Estimated completion is 2028-11-01.
What conditions does trial NCT05098210 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma.
What interventions are being tested in trial NCT05098210?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Echocardiography (PROCEDURE), Poly ICLC (DRUG), Multigated Acquisition Scan (PROCEDURE), Neoantigen Peptide Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05098210?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05098210 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Anatomic Stage IV Breast Cancer AJCC v8
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.