Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05098210

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

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer, PD1/PD-L1 Inhibitor-Refractory Melanoma, and Pretreated Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
25 (estimated)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

OUTLINE: Patients receive poly ICLC intramuscularly (IM) once weekly in weeks when no vaccine is given. Beginning 2 weeks after starting poly ICLC, patients receive personalized neo-antigen peptide vaccine IM once every 4 weeks and nivolumab intravenously (IV) every 2 or 4 weeks. Treatment continues for 25 weeks in the absence of disease progression or unacceptable toxicity. Patients determined to have clinical benefit on a first course of treatment may repeat a 6-month course of treatment as described above. Patients then receive nivolumab IV every 2 or 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients may undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo tumor biopsy, blood sample collection, and computed tomography (CT) and/or positron emission tomography (PET) throughout the study. After completion of study treatment, patients are followed up at 24, 36, and 48 weeks. Patients who do not have disease progression and continue nivolumab monotherapy or off treatment will continue post-treatment follow up for an additional 12 months.

Conditions

Interventions

TypeNameDescription
BIOLOGICALNeoantigen Peptide VaccineGiven IM
BIOLOGICALNivolumabGiven IV
DRUGPoly ICLCGiven IM
PROCEDUREEchocardiographyUndergo ECHO
PROCEDUREMultigated Acquisition ScanUndergo MUGA
PROCEDUREBiopsyUndergo tumor biopsy
PROCEDUREBiospecimen CollectionUndergo blood sample collection
PROCEDUREComputed TomographyUndergo CT or PET/CT
PROCEDUREPositron Emission TomographyUndergo PET or PET/CT

Timeline

Start date
2022-06-09
Primary completion
2027-11-01
Completion
2028-11-01
First posted
2021-10-28
Last updated
2026-03-12

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05098210. Inclusion in this directory is not an endorsement.