NCT05098210View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

June 9, 2022

Primary Completion Date

November 1, 2026

Study Completion Date

November 1, 2027

Conditions
Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Locally Advanced Cutaneous MelanomaLocally Advanced Mucosal MelanomaMetastatic Acral MelanomaMetastatic Conjunctival MelanomaMetastatic Cutaneous MelanomaMetastatic HER2-Negative Breast CarcinomaMetastatic Hormone Receptor-Positive Breast CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic Mucosal MelanomaPathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Recurrent Cutaneous MelanomaRecurrent HER2-Negative Breast CarcinomaRecurrent Hormone Receptor-Positive Breast CarcinomaRecurrent Lung Non-Small Cell CarcinomaRecurrent Mucosal MelanomaStage III Lung Cancer AJCC v8Stage IV Lung Cancer AJCC v8Unresectable Acral MelanomaUnresectable Cutaneous MelanomaUnresectable Lung Non-Small Cell CarcinomaUnresectable Mucosal Melanoma
Interventions
BIOLOGICAL

Neoantigen Peptide Vaccine

Given IM

BIOLOGICAL

Nivolumab

Given IV

DRUG

Poly ICLC

Given IM

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET or PET/CT

Trial Locations (1)

98109

RECRUITING

Fred Hutch/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
collaborator

Amazon, Inc.

INDUSTRY

lead

Fred Hutchinson Cancer Center

OTHER