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Triple Negative Breast CancerPhase 1NCT03362060

PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer

A Phase 1 study testing Pembrolizumab and PVX-410 in people with Triple Negative Breast Cancer and Metastatic Breast Cancer, run by Massachusetts General Hospital at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This research study is studying immunotherapy as a possible treatment for metastatic Triple Negative Breast Cancer (TNBC) in participants who are HLA-A2+. The drugs involved in this study are: PVX-410 Pembrolizumab Hiltonol Montanide Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pembrolizumab and PVX-410
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesUnited States
Study dates
12 Dec 2017to 30 Dec 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent for the study.
  • Female aged ≥18 years on the day of signing informed consent.
  • HLA A2+ by deoxyribonucleic acid (DNA) sequence analysis (by history with documentation or as part of this study).
  • Histopathological diagnosis of metastatic or inoperable locally advanced TNBC that meets the following criteria:
  • --Triple negative defined as Estrogen Receptor (ER)<1%, Progesterone Receptor (PR)<1%, and Human Epidermal Growth Factor Receptor 2 (HER2) negative according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines by local testing according to institutional standards.
  • For tumors with equivocal interpretation of receptor status (e.g., ER/PR ≥1% "weak" or "faint" staining), the Principal Investigator will have final determination of triple-negative status. For tumors with discrepant receptor results between 2 or more biopsies (including metastatic and/or early stage biopsies), the Principal Investigator will have final determination of triple negative status, but in general the most recent biopsy can be used for eligibility purposes. If receptor testing is not available on a metastatic biopsy, the primary tumor test result is acceptable.
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  • Metastatic or inoperable locally advanced disease is defined as either: histologically confirmed metastatic breast cancer by biopsy; or locally advanced breast cancer that, in the opinion of the treating physician, is not amenable to curative intent surgical resection; or, radiological or clinical evidence suggestive and supportive of metastatic disease without a documented metastatic biopsy, provided the patient has a prior diagnosis of TNBC that otherwise meets the eligibility criteria.
  • --Ductal, lobular, mixed, or metaplastic histology.
  • Measurable disease, as determined by RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix section 16.1)
  • At least one line of prior systemic therapy for metastatic or recurrent breast cancer (there is no limit to the number of prior therapies).
  • Adequate normal organ and marrow function within 10 days of planned treatment initiation, as defined below:
  • Hematologic
  • Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin dependency (within 7 days of assessment)
  • Absolute neutrophil count (ANC) ≥1.5x10^9/L (≥1500 per mm3)
  • Platelet count ≥100x109/L (≥100,000 per mm3) Renal
  • Serum creatinine ≤1.5 x the upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥60 mL/min for patients with creatinine levels >1.5 x institutional Upper Limit of Normal (ULN) (calculated per institutional standard). (Glomerular filtration rate can be used in place of creatinine or creatinine clearance.) Hepatic
  • Serum bilirubin ≤1.5 x institutional ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 x ULN
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤2.5 x institutional ULN OR ≤5 x ULN for patients with known liver metastases.
  • Albumin ≥2.5 mg/dL Coagulation
  • International normalized ratio (INR) or prothrombin time (PT) ≤1.5 x ULN, unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Activated partial thromboplastin time (aPTT) ≤1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Other
  • Lactate Dehydrogenase (LDH) ≤1.5 x institutional ULN
  • Willing to provide archived tissue for correlative studies. If no archived sample is available the patient will still be eligible.
  • Negative virology/serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) DNA.
  • Either of non-reproductive potential (i.e., post-menopausal by history of age ≥50 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, history of bilateral tubal ligation, or history of bilateral oophorectomy) OR must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • If of childbearing potential (i.e., does not meet criteria for non-reproductive potential above), willing to use 2 methods of birth control, or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment
  • Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, including follow-up

Who cannot join

  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study treatment.
  • Previous enrollment in the present study.
  • Mucinous or tubal histology or other good prognosis histology.
  • Known hypersensitivity to any component of PVX-410, Hiltonol®, Montanide, pembrolizumab, or excipients.
  • Receipt of the last dose or treatment of anti-cancer chemotherapy, radiotherapy, surgery, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization ≤2 weeks (4 weeks for any monoclonal Antibody (mAb), 6 weeks for nitrosoureas or mitomycin C) prior to first dose of study treatment, or has not recovered (i.e., to ≤Grade 1 or Baseline) from clinically significant Adverse Events (AEs) due to these previously administered agents.
  • Patients with ≤Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
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  • Subjects with other irreversible toxicity (e.g., hearing loss) or reversible toxicity (e.g. alopecia) that is not reasonably expected to be exacerbated by the investigational product and is not expected to interfere with study participation may be included.
  • If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Received a live vaccine within 30 days of planned start of study therapy.
  • --Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Ongoing or planned systemic anti-cancer therapy or radiation therapy.
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment.
  • Has a known history of active Tuberculosis (Bacillus Tuberculosis).
  • History of allogeneic organ transplant.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for management of brain metastases for at least 7 days prior to study treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Known history of non-infectious pneumonitis that required steroids or any evidence of active pneumonitis.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • History or current evidence of any other condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Pembrolizumab in HLA-A2+ Patients With Metastatic Triple Negative Breast Cancer (TNBC)

This research study is studying immunotherapy as a possible treatment for metastatic Triple Negative Breast Cancer (TNBC) in participants who are HLA-A2+.

The drugs involved in this study are:

  • PVX-410
  • Pembrolizumab
  • Hiltonol
  • Montanide
Read the detailed description

This research study is a Phase Ib clinical trial, which tests the safety of an investigational drug combination and also tries to better understand how the investigational intervention affects the body.

"Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of PVX-410 and pembrolizumab as a treatment regimen for this specific disease.

The FDA has not approved PVX-410 as a treatment for any disease. PVX-410 is a type of vaccine that may help the immune system stimulate immunity against the cancer cells.

The FDA has not approved pembrolizumab for this specific disease but it has been approved in the United Sates for other types of cancer.

Pembrolizumab is a drug that may treat cancer by working with the immune system. The immune system is the body's natural defense against disease. The immune system sends types of cells throughout the body to detect and fight infections and diseases, including cancer. For some types of cancer, the immune cells do not work as they should and are prevented from attacking the tumors. Pembrolizumab is thought to work by blocking a protein in the cells called Programmed Death-1 (PD-1), which then allows these cells and other parts of the immune system to attack tumors.

In this research study, the investigators are studying the body's immune response to the PVX-410 study vaccine in combination with pembrolizumab. This study will help researchers understand if the vaccine and pembrolizumab can work together to help the body's immune system recognize and treat triple negative breast cancer. The investigators are also studying the safety of the PVX-410 together with the pembrolizumab

Being tested
Pembrolizumab, PVX-410
Keywords
Triple Negative Breast Cancer, Vaccine, Immunotherapy, PD-1 Inhibitor, Metastatic Breast Cancer
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

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

  • PembrolizumabDrug

    Also called Keytruda

    Pembrolizumab is a monoclonal antibody checkpoint inhibitor that blocks a protein in T-cells cells called PD-1, which then allows these cells and other parts of the immune system to attack tumors

  • PVX-410Biological

    PVX-410 is a type of vaccine composed of 4 9-amino acid peptides that may help the immune system stimulate immunity against cancer cells

Study groups in NCT03362060
Study groupRoleWhat they receive
PVX-410Experimental* PVX-410 vaccine at W0, 1, 2, 3, 4, and 5 followed by booster PVX-410 vaccine doses at W10 and 28 * Pembrolizumab will be administered every 3 weeks intravenously starting with week 1
Receives: Drug: Pembrolizumab; Biological: PVX-410

What is being measured

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

  1. Immune Response following treatment with PVX-410 in combination with pembrolizumab

    The fold activation of T cells from blood of treated patients at week 10 compared to baseline

    Measured: 3 years

Secondary outcomes (5)

  1. Late Immune response after treatment with PVX-410 and pembrolizumab

    The fold activation of T cells from blood of treated patients at week 28 compared to baseline.

    Measured: 3 years

  2. Incidence of treatment emergent adverse events (safety and tolerability) of PVX-410 in combination with pembrolizumab

    Number of patients who develop treatment emergent adverse events according to the Common Toxicity Criteria of Adverse Events (CTCAE) version 4.0

    Measured: 3 years

  3. Progression Free Survival

    The median time from study enrollment to disease progression of all treated participants.

    Measured: 3 years

  4. Overall Survival

    The median time from study enrollment of all participants until death of all treated participants.

    Measured: 3 years

  5. Response rate

    The rate of RECIST defined responses (complete and partial response).

    Measured: 3 years

Timeline

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

  1. First posted5 Dec 2017
  2. Study start12 Dec 2017
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03362060
Sponsor's protocol ID
17-328
Status last verified
Jun 2026
First submitted
27 Nov 2017
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pembrolizumab and PVX-410 in people with Triple Negative Breast Cancer and Metastatic Breast Cancer, run by Massachusetts General Hospital at 3 sites 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 28 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune Response following treatment with PVX-410 in combination with pembrolizumab (time frame: 3 years). 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 NCT03362060.

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 17 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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