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Anatomic Stage III Breast Cancer AJCC v8Phase 1/2PNeoVCANCT05269381

Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors

A Phase 1/2 study testing Cyclophosphamide, Neoantigen Peptide Vaccine and Pembrolizumab in people with Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IIIA Breast Cancer AJCC v8, 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
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Trial summary

This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Cyclophosphamide, Neoantigen Peptide Vaccine and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteUnited States
Study dates
31 Mar 2022to 31 Mar 2028
Phase
Phase 1/2
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • ALL PHASES:
  • Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:
  • Pregnant person
  • Nursing person unwilling to stop breast feeding
  • Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle
  • Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens
Show all 80Show fewer
  • History of myocardial infarction ≤ 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
  • PHASE I PRE-REGISTRATION:
  • Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment
  • Uncontrolled illness including, but not limited to:
  • Ongoing or active infection
  • Psychiatric illness/social situations
  • Congestive heart failure with New York Heart Association (NYHA) class III or IV moderate to severe objective evidence of cardiovascular disease
  • Stroke ≤ 3 months prior to pre-registration
  • Significant cardiac arrhythmia or unstable angina
  • Any other conditions that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered treatment for primary neoplasm, except pembrolizumab
  • Any prior hypersensitivity or adverse reaction to GM-CSF
  • Other active malignancy ≤ 3 years prior to pre-registration
  • EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
  • NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • History of active autoimmune disease (AD) that required systemic treatment in ≤ 30 days (i.e., use of disease modifying agents, corticosteroids > 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration
  • NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded PHASE I REGISTRATION
  • Any of the following prior therapies:
  • Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) ≤ 3 weeks prior to cycle 1 day 1 (C1D1) neoantigen vaccinations
  • Radiation ≤ 2 weeks prior to C1D1 neoantigen vaccinations
  • Major Surgery ≤ 4 weeks prior to C1D1 neoantigen vaccinations
  • Received live vaccine ≤ 30 days prior to C1D1 neoantigen vaccinations
  • NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be > 14 days from first dose of vaccination on study
  • CTCAE ≥ Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity
  • Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or history of rhabdomyolysis
  • Active ADs that require chronic systemic steroids (> 10 mg daily prednisone equivalent) or immunosuppressive agents
  • Systemic corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications ≤ 14 days prior to registration
  • NOTE: Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent permitted in absence of active AD
  • Patients will also be excluded based on tissue/RNA/DNA quality and quantity. If any of the following quality and quantity thresholds are not met, the patient will be excluded:
  • Tumor tissue cellularity ≥ 30%
  • Sufficient tissue (fresh frozen or FFPE) for both DNA and RNA sequencing with passing cellularity.
  • ≥ 30% of tumor RNA with fragment sizes are ≥ 200 base pairs (DV200 ≥ 30)
  • < 10% of DNA fragments are smaller than 1 kb
  • Sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and RNAseq according to the Mayo sequencing core (note: kits and technologies change over time, so these are not fixed numbers)
  • Evidence of leptomeningeal disease or central nervous system metastases that are untreated, symptomatic, or require steroids >10 mg daily prednisone equivalent
  • NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases defined as no evidence of progression for ≥4 weeks on brain imaging (MRI or CT scan)
  • PHASE II PRE-SCREENING:
  • Uncontrolled illness including, but not limited to:
  • Ongoing or active infection
  • CHF with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease
  • Significant cardiac arrhythmia or unstable angina
  • Any other conditions that would limit compliance with study requirements
  • Any prior hypersensitivity or adverse reaction to GM-CSF
  • Other active malignancy ≤ 3 years prior to pre-screening
  • EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
  • NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • Known history of active AD that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-screening
  • NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.
  • PHASE II PRE-REGISTRATION
  • Uncontrolled illness including, but not limited to:
  • Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease
  • Significant cardiac arrhythmia or unstable angina
  • Any other conditions that would limit compliance with study requirements
  • Any prior hypersensitivity or adverse reaction to GM-CSF
  • Other active malignancy ≤ 3 years prior to pre-registration
  • EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
  • NOTE: If history of prior malignancy, must not be receiving other specific treatment for cancer
  • Known history of active AD that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids > 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration
  • NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.
  • Patients will also be excluded based on tissue/RNA/DNA quality and quantity. If any of the following quality and quantity thresholds are not met, patient will be excluded: (1) tumor tissue cellularity equal to or greater than 30%; (2) there are ≥ 2 cores with passing cellularity; (3) ≥ 30% of tumor RNA with fragment sizes are ≥ 200 base pairs (DV200 ≥ 30); (4) < 10% of DNA fragments are smaller than 1 kb; and (5) sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and whole transcriptome sequencing (RNAseq) according to Mayo sequencing core. (Kits and technologies change overtime, so these are not fixed numbers.)
  • PHASE II REGISTRATION
  • Evidence of metastatic disease or recurrence
  • Any of the following prior therapies:
  • Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) ≤ 3 weeks prior to study treatment
  • Radiation ≤ 2 weeks prior to study treatment
  • Major surgery ≤ 4 weeks prior to study treatment
  • Received live vaccine ≤ 30 days prior to study treatment
  • NOTE: Continuation of pembrolizumab per standard of care is allowed
  • NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be > 14 days from first dose of vaccination on study
  • CTCAE ≥ grade 3 TEAE to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity
  • Neuromuscular disorders (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or history of rhabdomyolysis
  • Active ADs that require chronic systemic steroids (> 10 mg daily prednisone equivalent) or immunosuppressive agents
  • Other inclusion/exclusion criteria as indicated per protocol not listed here due to limitation in number of characters (text) allowed.

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 Florida

    Jacksonville, Florida, 32224-9980

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

    Yanyan Lou, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the safety of personalized neoantigen peptide vaccine in combination with pembrolizumab in advanced solid cancers. (Phase I and Pilot Cohort 5) II. To evaluate and estimate 24-months event-free survival (EFS) rate per Kaplan-Meier method in triple-negative breast cancer (TNBC) patients with residual cancer burden-2 and 3 (RCB-2 and RCB-3) after neoadjuvant pembrolizumab-based chemotherapy treated with neoantigen vaccine in combination with pembrolizumab. (Phase II Cohort 3) III. To evaluate and estimate 24-months event-free survival (DFS) rate per Kaplan-Meier method in stage II/III non-small cell lung cancer (NSCLC) patients after surgery treated with neoantigen vaccine in combination with pembrolizumab. (Phase II Cohort 4)

SECONDARY OBJECTIVES:

  1. To evaluate and estimate the immunogenicity response rate in patients with advanced solid cancers receiving personalized neoantigen peptide vaccine in combination with pembrolizumab. (Phase I and Pilot Cohort 5) II. To obtain preliminary information on the immunogenicity of neoantigen in induction of specific cellular immune responses and humoral immune response.

III. To evaluate and estimate the immunogenicity response rate in TNBC patients with residual cancer burden-2 and 3 (RCB-2 and RCB-3) after neoadjuvant pembrolizumab-based chemotherapy treated with neoantigen vaccine in combination with pembrolizumab. (Phase II Cohort 3) IV. To evaluate adverse event profile in in TNBC patients with residual cancer burden-2 and 3 (RCB-2 and RCB-3) after neoadjuvant pembrolizumab-based chemotherapy treated with neoantigen vaccine in combination with pembrolizumab. (Phase II Cohort 3) V. To evaluate and estimate the vaccine immunogenicity response rate in stage II/III NSCLC patients after surgery treated with neoantigen vaccine in combination with pembrolizumab. (Phase II Cohort 4) VI. To evaluate adverse event profile in stage II/III NSCLC patients after surgery treated with neoantigen vaccine in combination with pembrolizumab. (Phase II Cohort 4)

EXPLORATORY OBJECTIVES:

  1. To obtain preliminary information on the immunogenicity of neoantigen in induction of specific cellular immune responses and humoral immune response in patients with selected advanced solid tumors. (Phase I and Pilot Cohort 5) II. To obtain preliminary estimates of efficacy as measured by objective response rate (ORR based on Response Evaluation Criteria in Solid Tumors [RECIST]) of personalized neoantigen peptide vaccine and pembrolizumab in patients with selected advanced solid tumors. (Phase I and Pilot Cohort 5) III. To obtain preliminary information of immunity persistence, as well as pre-existing immunity in patients with selected advanced solid tumors. (Phase I and Pilot Cohort 5) IV. To obtain preliminary information on the immunogenicity of neoantigen in induction of specific cellular immune responses and humoral immune response in Cohort 1 (TNBC patients with RCB-2 and RCB-3) and 2 (stage II/III NSCLC patients) separately. (Phase II) V. To obtain preliminary information of immunity persistence, as well as pre-existing immunity in Cohort 1 (TNBC patients with RCB-2 and RCB-3) and 2 (stage II/III NSCLC patients) separately. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of personalized neoantigen vaccine followed by a phase II study. Patients are assigned to 1 of 5 cohorts.

COHORT 1: Patients receive cyclophosphamide intravenously (IV) on day -3. Patients then receive personalized neoantigen vaccine with sargramostim (GM-CSF) subcutaneously (SC) on days 1, 4, 8, and 15 of cycle 1 and on day 1 of cycle 2 in the absence of disease progression or unacceptable toxicity.

COHORT 2: Patients receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

COHORT 3: Patients with TNBC receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle or as clinically indicated. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

COHORT 4: Patients with NSCLC receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle or as clinically indicated. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PILOT COHORT 5: Patients with ILC receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembroblizumab IV on day of each cycle or as clinically indicated. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

All patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.

After completion of study treatment, patients are followed up at 30 days and then every 3 months up to 2 years from study enrollment.

Being tested
Cyclophosphamide, Neoantigen Peptide Vaccine, Pembrolizumab, Sargramostim, Biospecimen Collection
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Melanoma, Carcinoma, Merkel Cell

What participants receive

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

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given IV

  • Neoantigen Peptide VaccineBiological

    Receive personalized neoantigen vaccine SC

  • PembrolizumabBiological

    Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475

    Given IV

  • SargramostimBiological

    Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine

    Given SC

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Blood Sample Collection, Specimen Collection

    Undergo blood sample collection

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography (CAT), computerized axial tomography

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

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

    Undergo MRI

Study groups in NCT05269381
Study groupRoleWhat they receive
Cohort 1(cyclophosphamide, vaccine) ** NO LONGER ENROLLING **ExperimentalNO LONGER ENROLLING Patients receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and on day 1 of cycle 2 in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as CT or MRI throughout the study.
Receives: Drug: Cyclophosphamide; Biological: Neoantigen Peptide Vaccine; Biological: Sargramostim; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging
Cohort 2 (cyclophophamide, vaccine, pembrolizumab) ** NO LONGER ENROLLING **ExperimentalNO LONGER ENROLLING Patients receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as CT or MRI throughout the study.
Receives: Drug: Cyclophosphamide; Biological: Neoantigen Peptide Vaccine; Biological: Pembrolizumab; Biological: Sargramostim; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging
Cohort 3 (cyclophosphamide, vaccine, pembrolizumab) **NOT enrolling additional participants.**ExperimentalNOT enrolling additional participants. Enrollment status will be updated as more information becomes available. Patients with early-stage TNBC receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle or as clinically indicated. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as CT or MRI throughout the study.
Receives: Drug: Cyclophosphamide; Biological: Neoantigen Peptide Vaccine; Biological: Pembrolizumab; Biological: Sargramostim; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging
Cohort 4 (cyclophosphamide, vaccine, pembrolizumab) **NOT enrolling additional participants.**ExperimentalNOT enrolling additional participants. Enrollment status will be updated as more information becomes available. Patients with early-stage NSCLC receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle or as clinically indicated. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as CT or MRI throughout the study.
Receives: Drug: Cyclophosphamide; Biological: Neoantigen Peptide Vaccine; Biological: Pembrolizumab; Biological: Sargramostim; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging
Pilot Cohort 5 (cyclophosphamide, vaccine, pembrolizumab)ExperimentalPatients with ILC receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembroblizumab IV on day of each cycle or as clinically indicated. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as CT or MRI throughout the study.
Receives: Drug: Cyclophosphamide; Biological: Neoantigen Peptide Vaccine; Biological: Pembrolizumab; Biological: Sargramostim; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging

What is being measured

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

  1. Maximally tolerated dose (MTD) (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5)

    MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. For instance, those toxicities with an incidence of at least 25% will be observed with a probability of at least 82% (1-(1-0.25).

    Measured: Up to 2 years

  2. Dose Limiting Toxicity (DLT) (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5)

    DLT are defined to be adverse event (AE) occurring from day -3 through day 35 that is possibly, probably, or definitely related to neoantigen peptide vaccine with/without pembrolizumab and fulfills any of the following criteria using the National Cancer Institute's Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), version (v) 5.0

    Measured: Up to 2 years

  3. Incidence of adverse events (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5)

    The number and severity (grade) of all treatment related adverse events (AEs) will be tabulated and summarized. Non-hematologic AEs will be evaluated via the ordinal CTCAE v5.0 standard AE grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTCAE v5.0 standard AE grading. Both all grade and grade 3 and above AEs will be described and summarized in a similar fashion. Overall AE incidences as well as AE profiles by dose level and patient will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

    Measured: Up to 2 years from first vaccine administration

  4. Event free survival (EFS) (Phase II Cohort 3)

    EFS is defined as the length of time after primary treatment for a cancer ends until occurrence of complications or events that the treatment was intended to prevent or delay.

    Measured: Up to 2 years

  5. Disease-free survival (DFS) (Phase II Cohort 4)

    DFS is defined as the length of time after primary treatment for a cancer ends until any signs or symptoms of that cancer recur.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Immunogenicity response rate (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5)

    Will be defined as number of patients who have ≥ 20% of neoantigens formulated into vaccine with at least 3-folds of value increase at any timepoint within 24 weeks, divided by total number of evaluable patients. Evaluable patients are defined as patients who are properly registered and received at least one dose of vaccine.

    Measured: Within 24 weeks

  2. Incidence of adverse events (Phase II)

    Will be assessed using CTCAE v5.0. Defined as the proportion of patients experienced at least one grade 3, grade 4, or grade 5 of each type of AE during the protocol defined treatment. The binary endpoints will be estimated, in each cohort (or by dose level. Dose intensity and number of cycles will be summarized by mean, standard deviation, median, Q1, Q3, and range, in each cohort. The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be recorded for each patient. The frequency tables will be reviewed to determine the patterns.

    Measured: Up to 2 years

  3. Immunogenicity response rate (Phase II)

    Will be defined as number of patients who have ≥ 20% of neoantigens formulated into vaccine with at least 3-folds of value increase at any timepoint within 24 weeks, divided by total number of evaluable patients. Evaluable patients are defined as patients who are properly registered and received at least one dose of vaccine.

    Measured: Within 24 weeks

Timeline

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

  1. First posted8 Mar 2022
  2. Study start31 Mar 2022
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05269381
Sponsor's protocol ID
MC210102
Other IDs
NCI-2022-01258, 21-008509
Acronym
PNeoVCA
Status last verified
Aug 2026
First submitted
25 Feb 2022
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cyclophosphamide, Neoantigen Peptide Vaccine and Pembrolizumab in people with Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IIIA Breast Cancer AJCC v8, 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 0 inclusion and 80 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 20 Aug 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Maximally tolerated dose (MTD) (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5) (time frame: Up to 2 years). 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 NCT05269381.

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 20 Aug 2026.

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