Recruiting

Phase 1

MV-s-NAPA Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer

Sponsor:

Mayo Clinic

Code:

NCT04521764

Conditions

Anatomic Stage IV Breast Cancer AJCC v8

Invasive Breast Carcinoma

Metastatic Breast Adenocarcinoma

Recurrent Breast Carcinoma

Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein

Computed Tomography

Magnetic Resonance Imaging

Biopsy

Biospecimen Collection

Study Details

Brief summary:

This phase I trial investigates the side effects and best dose of using a modified measles virus, MV-s-NAP, in treating patients with invasive breast cancer that has spread to other places in the body (metastatic). Both the unmodified vaccination measles virus (MV-Edm) and this modified virus (MV-s-NAP) have been shown to multiply in and destroy breast cancer cells in the test tube and in research mice. MV-s-NAP has been altered by having an extra gene (piece of deoxyribonucleic acid \[DNA\]) so that virus can make a protein called helicobacter pylori neutrophil activating protein (NAP) which is normally expressed in inflammatory reactions. Monitoring blood, urine, tissue, and throat swab samples, and using imaging tests may help to determine whether MV-s-NAP has any impact on the amount of disease present in metastatic breast cancer patients.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8

Invasive Breast Carcinoma

Metastatic Breast Adenocarcinoma

Recurrent Breast Carcinoma

Stage IV Breast Cancer AJCC v6 and v7

Study ID

NCT04521764

Start date

Sep 23, 2020

Status verified date

Jul, 2026

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Aug 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age >= 18 years
COHORT 1 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)/progesterone receptor (PR) /HER2 status and radiographic evidence of distant metastatic disease
COHORTS 2 \& 3 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented ER/PR/HER2 status and radiographic evidence of distant metastatic or recurrent disease
COHORT 1 ONLY: Radiographic evidence of distant metastatic disease (using 7th edition American Joint Committee on Cancer \[AJCC\] criteria) with two discrete sites of measurable disease
COHORTS 2 \& 3 ONLY: Radiographic evidence of distant metastatic or recurrent disease (using 8th edition AJCC criteria) with at least one site of measurable disease
Prior therapies:

Patients with ER/PR positive, HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease and no longer be candidates for standard endocrine therapy or combination of endocrine therapy with other agents such as CDK4/6 inhibitors
Patients with HER2 positive breast cancer irrespective of ER/PR status must have received or no longer be candidates for HER2 directed therapy with trastuzumab or pertuzumab
Patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease
COHORT 1: At least one site of recurrent/metastatic disease that measures > 1 cm in greatest dimension (> 2 cm for lung lesions) and is amenable to safe percutaneous intratumoral administration of MV-s-NAP as determined by an interventional radiologist
COHORTS 2 \& 3 ONLY: At least 1 site of recurrent/metastatic disease measuring > 1 cm in greatest dimension \[> 2 cm for lung lesions\] (Note that if the lesion injected in cycle 1 is not amenable to re-injection, another lesion could be selected for injection
Absolute neutrophil count (ANC) >= 1500/uL (=< 7 days prior to registration)
Platelets (PLT >= 100,000/uL) (=< 7 days prior to registration)
Total bilirubin =< institutional upper limit of normal (=< 7 days prior to registration)
Aspartate aminotransferase (AST) =< 2 x upper limit of normal (ULN) (=< 7 days prior to registration)
Creatinine =< 1.5 x ULN (=< 7 days prior to registration)
Hemoglobin >= 9.0 g/dL (=< 7 days prior to registration)
Negative pregnancy test done =< 7 days prior to registration (for women of childbearing potential only)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Ability to provide informed written consent
Willingness to return to the Mayo Clinic enrolling institution for follow-up
Willingness to provide biologic samples for correlative research purposes
Life expectancy >= 12 weeks
Concomitant administration of a bone modifying agent (e.g., zoledronic acid or denosumab) is permitted for the prevention or management of skeletal related events in patients with bone metastases and documentation of tolerability with prior exposures

Exclusion Criteria:

Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
Clinical or radiographic suspicion of impending visceral crisis due to invasion or compression by tumor
Active infection =< 5 days prior to registration
History of other malignancy =< 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix
Any of the following prior therapies:

Chemotherapy =< 3 weeks prior to registration
Immunotherapy =< 4 weeks prior to registration
HER2 directed therapy =< 3 weeks prior to registration
Targeted therapy =< 2 weeks prior to registration (e.g., CDK4/6 inhibitors, everolimus)
Investigational agent =< 4 weeks prior to registration
Any viral or gene therapy prior to registration
Failure to fully recover from acute, reversible effects of prior systemic therapy regardless of interval since last treatment
New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \[SVT\])
Untreated or progressive central nervous system (CNS) metastases

NOTE: Patients with a history of treated brain metastases (surgical resection, whole brain radiation, and/or stereotactic radiosurgery) are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including < 28 days of study entry
Standing requirement for blood product support
Human immunodeficiency virus (HIV) positive test result or history of other immunodeficiency
History of organ transplantation
History of chronic hepatitis B or C
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)
Any concurrent medications that the principal investigator determines could interfere with the trial
Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids or low dose systemic steroids for physiologic replacement (e.g., Prednisone ≤10 mg/day)
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
Allergy to measles vaccine or history of severe reaction to prior measles vaccination
History of receiving the measles vaccination with the "killed vaccine" between 1963-1967 without subsequent re-immunization (2 doses) with the active, live vaccination."

Study Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 (single treatment MV-s-NAP)

Patients receive MV-s-NAP IT on day 1 in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy, and blood and urine sample collection throughout the study.

experimental: Cohort 2 (Every 21 day MV-s-NAP)

Patients receive MV-s-NAP IT on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy, and blood and urine sample collection throughout the study. (CLOSED TO ACCRUAL 6/9/2025)

experimental: Cohort 3 (Every 14 day MV-s-NAP)

Patients receive MV-s-NAP IT on day 1 of each cycle. Cycles repeat every 14 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood and urine sample collection throughout the study.

Interventions

Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein

Given IT

Computed Tomography

Undergo CT scan

Magnetic Resonance Imaging

Undergo MRI

Biopsy

Undergo tumor biopsy

Biospecimen Collection

Undergo blood and urine sample collection

Primary outcome measure

Maximum tolerated dose [ Time Frame: During the first cycle of treatment (each cycle = 21 days) ]
Best tumor response [ Time Frame: Up to 2 years ]
Incidence of adverse events [ Time Frame: Up to 2 years ]
Measles virus viremia [ Time Frame: Up to 2 years ]
Peripheral immune response [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Siddhartha Yadav, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-31.