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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: Recruiting Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by Fred Hutchinson Cancer Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Will be assessed by Common Terminology Criteria for Adverse Events version 5.0.

Conditions Studied

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 Metastatic Cutaneous Melanoma Metastatic Acral Melanoma Locally Advanced Mucosal Melanoma Locally Advanced Cutaneous Melanoma Metastatic Conjunctival Melanoma

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

FieldValue
Enrollment Target 25 participants
Start Date 2022-06-09
Est. Completion 2028-11-01
Phase Phase 1
Fred Hutchinson Cancer Center

483 total trials

What NCT05098210 shows while recruiting

NCT05098210 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (85% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Anatomic Stage IV Breast Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05098210's enrollment target sits among peer trials

25 40th of 59 higher than 19 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05098210

Source: ClinicalTrials.gov NCT05098210, the US trial registry maintained by the National Library of Medicine. NCT05098210 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.