Breast CancerPhase 1NCT02826434
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer
A Phase 1 study testing PVX-410, Durvalumab and Hiltonol in people with Breast Cancer, run by Massachusetts General Hospital at 5 sites in United States.
Trial summary
The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or III Triple Negative Breast Cancer. This research study is studying the safety, tolerability, and immune response of these treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PVX-410, Durvalumab and Hiltonol
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Aug 2016to Sep 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
- Written informed consent and any locally-required authorization obtained from the patient prior to performing any protocol-related procedures, including Screening evaluations.
- Females, ≥18 years at time of study entry.
- HLA-A2 positive by deoxyribonucleic acid (DNA) sequence analysis (by history or as part of this study).
- Histopathological diagnosis of triple negative breast cancer(TNBC) (ductal, lobular, mixed or metaplastic), 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/College of American Pathologists guidelines by local testing according to institutional standards. For tumors with equivocal interpretation of receptor status (e.g. "weak" or "faint" staining, the Principal Investigator will have final determination of triple negative status.
- Completed all planned therapy for Stage II or III TNBC (American Joint Committee on Cancer, 7th Edition) meeting the following guidelines:
- received neoadjuvant chemotherapy with residual invasive disease at surgery and/or completed adjuvant chemotherapy with or without radiation. (The patient may have had adjuvant and/or neoadjuvant chemotherapy for their disease). Adjuvant/neoadjuvant chemotherapy regimens must include at least 4 cycles of a standard chemotherapy regimen, and generally this should include one of the generally accepted standard regimens (including but not limited to: Adriamycin/Cytoxan-Taxol, Taxotere/Cytoxan, Adriamycin/Cytoxan, or Cytoxan/Methotrexate/Fluorouracil). For patients who received their standard chemotherapy as part of a clinical trial, the regimen should include at least 4 cycles of therapy.
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- All planned radiation therapy surgery for the treatment of the current cancer should be complete (not including plastic or reconstructive surgery).
- Patients with local-regional recurrence without evidence of distant metastases (no definite stage IV disease) who are treated with curative intent may be eligible following completion of all surgery and/or chemotherapy and/or radiotherapy. Such patients must have no evidence of residual disease by standard clinical and radiological examination (per Investigator discretion) following completion of curative intent treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix B).
- Adequate normal organ and marrow function as defined below:
- Hemoglobin ≥9.0 g/dL.
- absolute neutrophil count (ANC) ≥1.5 109/L (≥1500 per mm3).
- Platelet count ≥100 109/L (>100,000 per mm3).
- Serum bilirubin ≤1.5 institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology).
- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤2.5 ULN.
- gamma-glutamyltransferase (GGT), lactate dehydrogenase (LDH), and alkaline phosphatase ≤2.5 ULN.
- Serum creatinine clearance >40 mL/min by the Cockcroft-Gault formula 72 or by 24-hour urine collection for determination of creatinine clearance:
- Females:
- Creatinine Clearance (mL/min) = Weight (kg) x (140 - Age) 0.85 72 x serum creatinine (mg/dL)
- Negative virology/serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B (surface antigen), and hepatitis C.
- Female patients must either be of non-reproductive potential (i.e. post-menopausal by history of age ≥60 years old and no menses for 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test (β-human chorionic gonadotropin (HCG)) at the Screening visit. (If Screening visit pregnancy test was completed within 7 days of first treatment visit it does not need to be repeated. Patients with a negative pregnancy test at Screening beyond 7 days prior to treatment, but who otherwise meet all other criteria, may be registered to study but must have a repeat negative serum pregnancy test within 7 days of treatment and such testing may be done on day of first treatment prior to administration).
- If not postmenopausal or surgically sterile, study patients must be willing to practice at least one of the following methods of birth control for at least a menstrual cycle before and after study drug administration: (1) Total abstinence from sexual intercourse with a male; (2) Sexual intercourse with vasectomized male partner; (3) Other acceptable forms of birth control (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicide or cream); (4) Use of an intrauterine contraceptive device.
- Patient is 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
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Previous enrollment in the present study.
- Receipt of the last dose or treatment of anti-cancer therapy for the current cancer (chemotherapy, radiotherapy, surgery, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤4 weeks (6 weeks for nitrosoureas or mitomycin C) or >6 months prior to first dose of study drug.
- Any unresolved clinically significant treatment related toxicity of ≥Grade 1 intensity, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), from previous anti-cancer therapy. Patients with irreversible toxicity (eg, hearing loss, peripherally neuropathy) or reversible toxicity (eg, 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.
- Participation in another clinical study with an investigational product during the previous 4 weeks.
- Any previous treatment with a programmed cell death protein 1 (PD1) or PD-L1 inhibitor, including durvalumab.
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- Stage IV disease, confirmed by biopsy or unequivocal radiographic evidence (note: staging scans are not required, but should be performed at treating physician discretion in accordance with standard guidelines).
- Mucinous or tubal histology or other good prognosis histology.
- Ongoing or planned systemic anti-cancer therapy or radiation therapy.
- Pregnant or nursing.
- Known hypersensitivity to any component of the investigational product (PVX-410, durvalumab, or any excipient).
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction.
- Active or prior documented active autoimmune disease that has required systemic treatment. Note: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic (oral or iv) corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- History of primary immunodeficiency.
- History of allogeneic organ transplant.
- Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have evidence of acute or chronic hepatitis B, hepatitis C or HIV)
- Psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent.
- History or clinical evidence of any surgical or medical condition which the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating (eg, active or clinically significant history of disease involving a major organ system-vascular, cardiac, pulmonary, hepatic, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine or immunodeficiency, autoimmune or clinically significant active psychiatric disorders).
- Known history of previous clinical diagnosis of tuberculosis
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
- Weight < 30 kg
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts general Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
New York University School of Medicine
New York, New York, 10016
Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33607
About this study
Official title: A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Durvalumab in Human Leukocyte Antigen (HLA)-A2+ Subjects Following Standard Treatment of Stage II or III Triple Negative Breast Cancer
The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or III Triple Negative Breast Cancer. This research study is studying the safety, tolerability, and immune response of these treatments.
The names of the study interventions involved in this study are:
- PVX-410 Vaccine
- Durvalumab (MEDI4736)
Read the detailed description
This research study is a Phase Ib clinical trial, which tests the safety of an investigational intervention and also tries to better understand how the investigational intervention affects the body. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved PVX-410 and Durvalumab as a treatment for any disease.
- Durvalumab is a protein that affects your immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the body's natural immune response, but tumors can interrupt this pathway and partially resist or escape the immune system. By blocking the PD-L1 pathway, Durvalumab may help the immune system identify and catch tumor cells.
- PVX-410 is an investigational vaccine that is being developed to treat multiple myeloma and triple negative breast cancer.
- In this research study, the investigators are studying the body's immune response to the PVX-410 study vaccine in combination with Durvalumab. This study will help researchers understand if the vaccine and Durvalumab can work together to help the body's immune system recognize triple negative breast cancer. The investigators are also studying the safety of the PVX-410 vaccine alone and together with the Durvalumab.
- Conditions
- Breast Cancer
- Being tested
- PVX-410, Durvalumab, Hiltonol
- Keywords
- Breast Cancer, vaccine, immunotherapy, PD-L1 Inhibitor, triple negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVX-410Biological
This is a Vaccine that will be injected intramuscularly as a mixture with an adjuvant.
DurvalumabBiological
Also called MEDI4736
This is an intravenous infusion of a monoclonal antibody.
HiltonolDrug
Also called poly-ICLC
This is an intramuscular injection of an adjuvant to enhance the immune response to vaccine.
| Study group | Role | What they receive |
|---|---|---|
| PVX-410 and Durvalumab | Experimental | Each patient will receive 6 PVX-410 vaccine injections and 2 infusions of Durvalumab.
* The injection of PVX-410 will be co-administered with Hiltonol every 2 weeks for 6 injections.
* The infusion of Durvalumab will be given on the day of the 4th and 6th PVX-410 injection, for a total of 2 infusions. Receives: Biological: PVX-410; Biological: Durvalumab; Drug: Hiltonol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity Rate of PVX-410 in Combination With Durvalumab
To assess the safety of the vaccine and PDL1 inhibitor.
Measured: 4 Weeks
Secondary outcomes (3)
Immune Response Rate of cluster designation 8 (CD8)+ Cytotoxic T Lymphocytes (CTLs) to Vaccine-Specific Peptides
To assess the response of the immune system after treatment with the vaccine and PDL1 inhibitor.
Measured: 14 weeks from first dose
Disease-Free Survival
The duration of time from the complete remission until disease progression or death, whichever occurs first..
Measured: Up to approximately 5 years
Adverse events according to Common Toxicology Criteria for Adverse Events (CTCAE 4.0) will be assessed for the PVX-410 vaccine regimen alone versus PVX-410 vaccine regimen plus durvalumab
Adverse events will be assessed using Common Toxicology Criteria for Adverse Events (CTCAE 4.0)
Measured: From the start of treatment until 30 days after the end of treatment, up to approximately 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start18 Aug 2016
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- OncoPep, Inc., AstraZeneca
- Responsible party
- Principal investigator, Steven J Isakoff, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven Isakoff, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826434
- Sponsor's protocol ID
- 16-132
- Status last verified
- Sep 2025
- First submitted
- 5 Jul 2016
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Durvalumab in Human Leukocyte Antigen (HLA)-A2+ Subjects Following Standard Treatment of Stage II or III Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02826434
- Acronym / sponsor ID
- 16-132
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, vaccine, immunotherapy, PD-L1 Inhibitor, triple negative breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- OncoPep, Inc., AstraZeneca
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or III Triple Negative Breast Cancer. This research study is studying the safety, tolerability, and immune response of these treatments.
The names of the study interventions involved in this study are:
- PVX-410 Vaccine
- Durvalumab (MEDI4736)
Detailed description
This research study is a Phase Ib clinical trial, which tests the safety of an investigational intervention and also tries to better understand how the investigational intervention affects the body. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved PVX-410 and Durvalumab as a treatment for any disease.
- Durvalumab is a protein that affects your immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the body's natural immune response, but tumors can interrupt this pathway and partially resist or escape the immune system. By blocking the PD-L1 pathway, Durvalumab may help the immune system identify and catch tumor cells.
- PVX-410 is an investigational vaccine that is being developed to treat multiple myeloma and triple negative breast cancer.
- In this research study, the investigators are studying the body's immune response to the PVX-410 study vaccine in combination with Durvalumab. This study will help researchers understand if the vaccine and Durvalumab can work together to help the body's immune system recognize triple negative breast cancer. The investigators are also studying the safety of the PVX-410 vaccine alone and together with the Durvalumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVX-410 and Durvalumab | Experimental | Biological: PVX-410, Biological: Durvalumab, Drug: HiltonolEach patient will receive 6 PVX-410 vaccine injections and 2 infusions of Durvalumab. * The injection of PVX-410 will be co-administered with Hiltonol every 2 weeks for 6 injections. * The infusion of Durvalumab will be given on the day of the 4th and 6th PVX-410 injection, for a total of 2 infusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Written informed consent and any locally-required authorization obtained from the patient prior to performing any protocol-related procedures, including Screening evaluations.
- Females, ≥18 years at time of study entry.
- HLA-A2 positive by deoxyribonucleic acid (DNA) sequence analysis (by history or as part of this study).
- Histopathological diagnosis of triple negative breast cancer(TNBC) (ductal, lobular, mixed or metaplastic), 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/College of American Pathologists guidelines by local testing according to institutional standards. For tumors with equivocal interpretation of receptor status (e.g. "weak" or "faint" staining, the Principal Investigator will have final determination of triple negative status.
- Completed all planned therapy for Stage II or III TNBC (American Joint Committee on Cancer, 7th Edition) meeting the following guidelines:
Key exclusion criteria (23 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Previous enrollment in the present study.
- Receipt of the last dose or treatment of anti-cancer therapy for the current cancer (chemotherapy, radiotherapy, surgery, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤4 weeks (6 weeks for nitrosoureas or mitomycin C) or >6 months prior to first dose of study drug.
- Any unresolved clinically significant treatment related toxicity of ≥Grade 1 intensity, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), from previous anti-cancer therapy. Patients with irreversible toxicity (eg, hearing loss, peripherally neuropathy) or reversible toxicity (eg, 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.
- Participation in another clinical study with an investigational product during the previous 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVX-410This is a Vaccine that will be injected intramuscularly as a mixture with an adjuvant. | Biological | PVX-410 and Durvalumab |
| DurvalumabAlso: MEDI4736This is an intravenous infusion of a monoclonal antibody. | Biological | PVX-410 and Durvalumab |
| HiltonolAlso: poly-ICLCThis is an intramuscular injection of an adjuvant to enhance the immune response to vaccine. | Drug | PVX-410 and Durvalumab |
Primary outcome
Dose Limiting Toxicity Rate of PVX-410 in Combination With Durvalumab
Time frame: 4 Weeks
To assess the safety of the vaccine and PDL1 inhibitor.
3 secondary outcomes
Immune Response Rate of cluster designation 8 (CD8)+ Cytotoxic T Lymphocytes (CTLs) to Vaccine-Specific Peptides
Time frame: 14 weeks from first dose
Disease-Free Survival
Time frame: Up to approximately 5 years
Adverse events according to Common Toxicology Criteria for Adverse Events (CTCAE 4.0) will be assessed for the PVX-410 vaccine regimen alone versus PVX-410 vaccine regimen plus durvalumab
Time frame: From the start of treatment until 30 days after the end of treatment, up to approximately 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Isakoff, MD, PhD principal investigator
Massachusetts General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PVX-410, Durvalumab and Hiltonol in people with Breast Cancer, run by Massachusetts General Hospital at 5 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 23 inclusion and 23 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Dose Limiting Toxicity Rate of PVX-410 in Combination With Durvalumab (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.