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Anatomic Stage IV Breast Cancer AJCC v8Phase 1NCT04521764

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

A Phase 1 study testing Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein, Computed Tomography and Magnetic Resonance Imaging in people with Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein, Computed Tomography and Magnetic Resonance Imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
23 Sep 2020to 15 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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."

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Siddhartha Yadav, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients With Metastatic Breast Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measles virus genetically engineered to express NAP (oncolytic measles virus encoding helicobacter pylori neutrophil-activating protein (modified virus strain neutrophil activating protein [MV-s- NAP) in patients with metastatic breast cancer.

II. To determine the safety and toxicity of one-time intratumoral administration of MV-s-NAP in patients with metastatic breast cancer.

III. To determine the safety and toxicity of serial intratumoral administration of MV-s-NAP in patients with metastatic breast cancer.

SECONDARY OBJECTIVES:

  1. To assess in a preliminary fashion antitumor efficacy of this approach by following radiographic response and time to progression.

Ia. Response at and away from the site of MV-s-NAP administration will be evaluated.

CORRELATIVE OBJECTIVES:

  1. To assess viremia, viral replication, and measles virus shedding/persistence following intratumoral administration.

II. To determine the time course of viral infection and viral gene expression in treated/untreated lesions.

III. To determine immune response development against MV, the therapeutic s-NAP transgene, and the tumor.

IV. To obtain preliminary assessments of PD-L1 expression in tumor cells and tumor infiltrating lymphocytes (TILs).

OUTLINE: Patients are assigned to 1 of 3 cohorts.

COHORT 1: Patients receive MV-s-NAP intratumorally (IT) on day 1 in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), tumor biopsy and blood and urine sample collection throughout the study.

COHORT 2 (CLOSED TO ACCRUAL 6/9/2025): 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.

COHORT 3: 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.

After completion of study treatment, patients are followed up every 3 months during year 1, and then every 6 months during year 2.

Being tested
Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein, Computed Tomography, Magnetic Resonance Imaging, Biopsy, Biospecimen Collection
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating ProteinBiological

    Also called MV Encoding NAP, MV-s-NAP, Oncolytic Measles Virus Encoding H. pylori NAP

    Given IT

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT scan, Computed Axial Tomography, computerized axial tomography

    Undergo CT scan

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and urine sample collection

Study groups in NCT04521764
Study groupRoleWhat they receive
Cohort 1 (single treatment MV-s-NAP)ExperimentalPatients 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.
Receives: Biological: Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biopsy; Procedure: Biospecimen Collection
Cohort 2 (Every 21 day MV-s-NAP)ExperimentalPatients 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)
Receives: Biological: Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection
Cohort 3 (Every 14 day MV-s-NAP)ExperimentalPatients 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.
Receives: Biological: Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biopsy; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

    This is defined as the highest dose level among those under consideration where at most one of 6 patients develops a dose limiting toxicity, and two or more of the 3-6 patients treated at the next higher dose level develop a dose limiting toxicity.

    Measured: During the first cycle of treatment (each cycle = 21 days)

  2. Best tumor response

    The best tumor response in the injected and non-injected lesion will be determined using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Results will be tabulated for the entire cohort and by breast cancer subtype in terms of whether there was response in none of the lesions, only the injected lesion, or both lesions.

    Measured: Up to 2 years

  3. Incidence of adverse events

    The maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity, as well as the percentage of patients developing a severe (grade 3 or higher) toxicity, will be determined.

    Measured: Up to 2 years

  4. Measles virus viremia

    Defined as detection of any titer of virus by quantitative real time-polymerase chain reaction performed with patient peripheral blood mononuclear cells. Viremia will be examined in terms of the day and dose level it was detected, as well as the time to recovery.

    Measured: Up to 2 years

  5. Peripheral immune response

    Peripheral immune response specific to measles virus is defined as detection of serum IgG anti-measles antibody levels of > 20.0 EU/mL by the Enzyme Immunoassay. Peripheral anti-neutrophil activating protein (NAP) transgene response will be represented by antibody titers determined by an antigen-mediated enzyme linked immunosorbent assay against purified helicobacter pylori NAP antigen. Systemic induction of HMGB1 will also be determined. All of these factors will be examined in terms of the day and dose level they were detected, as well as the time to recovery. For each dose level, the point at which viral replication and measles virus shedding is no longer seen will be tabulated.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Tumor response

    The best tumor response in the injected and non-injected lesion will be determined using Response Evaluation Criteria in Solid Tumors (RECIST). Results will be tabulated by dose level and whether there was a response in none of the lesions, only the injected lesion, or both lesions.

    Measured: Up to 2 years

  2. Progression-free survival (PFS)

    PFS is defined as the time from study entry to the documentation of disease progression.

    Measured: Up to 2 years

  3. Overall survival (OS)

    OS is defined as the time from study entry to death due to any cause.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start23 Sep 2020
  3. Primary completion15 Aug 2027 (estimated)
  4. Study completion15 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04521764
Sponsor's protocol ID
MC1733
Other IDs
17-008299
Status last verified
Jul 2026
First submitted
17 Aug 2020
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Viker KB, Steele MB, Iankov ID, Concilio SC, Ammayappan A, Bolon B, Jenks NJ, Goetz MP, Panagioti E, Federspiel MJ, Liu MC, Peng KW, Galanis E. Preclinical safety assessment of MV-s-NAP, a novel oncolytic measles virus strain armed with an H . pylori immunostimulatory bacterial transgene. Mol Ther Methods Clin Dev. 2022 Jul 31;26:532-546. doi: 10.1016/j.omtm.2022.07.014. eCollection 2022 Sep 8.

    PubMed 36092362

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein, Computed Tomography and Magnetic Resonance Imaging in people with Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: During the first cycle of treatment (each cycle = 21 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04521764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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