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Breast CancerPhase 2NCT02593227

Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer

A Phase 2 study testing Low dose FRα vaccine, Cyclophosphamide and High dose FRα vaccine in people with Breast Cancer, run by Marker Therapeutics, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III… 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?
Low dose FRα vaccine, Cyclophosphamide and High dose FRα vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
11 sitesUnited States
Study dates
Apr 2016to 15 Jul 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Female patient, age 18 years or older;
  • Completely resected unilateral or bilateral primary carcinoma of the breast
  • Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
  • Primary tumor was negative for ER, PR (cut-off for positivity is >10% positive tumor cells with nuclear staining) and negative for Her2-neu (0 or 1+ on immunohistochemistry and/or normal gene copy number by in-situ hybridization); Central review is not required.
  • Completed primary treatment (surgery and radio/chemotherapy in adjuvant and/or neo-adjuvant setting) <360 days prior to first vaccination.
  • Completed last cycle of chemotherapy or radiation > 60 days prior to first vaccination
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  • Either clinical or pathological Stage I (T1c), II, or III according to AJCC 7th edition
  • Note that patients with (i) non-invasive breast cancer (DCIS) alone, (ii) incidental (microscopic) nodal cancer without a primary tumor (pN1mi), or (iii) metastatic disease are excluded.
  • Resected tumor: No evidence of gross tumor at the surgical resection margin noted in the final surgery report. No evidence of gross residual adenopathy
  • Karnofsky index >= 70%;
  • Life expectancy of at least 5 years, disregarding the diagnosis of cancer;
  • Adequate Blood, renal and hepatic function, as determined within 28 days from registration:
  • ANC ≥ 1,500 / mm3
  • Platelet ≥ 100,000 / uL
  • Hgb > 9 g/dL
  • Creatinine ≤ 1.5 x ULN or 24-hour urine < Grade 2
  • Urinalysis with < 2+ proteinuria
  • Serum albumin ≥ 3 g/dL
  • SGOT (AST) ≤ 3 x ULN
  • Anti-nuclear antibody (ANA) negative or low-positive institutional range, as determined within 28 days from registration. Intermediate values (usually defined by a titer of ≤1:80, or as indicated by institutional range) are acceptable if there are, in the opinion of the Investigator, no early signs of an autoimmune disease.
  • Primary tumor is available for shipment to central laboratory for analysis of FRα expression by IHC.
  • Patients must be, in the opinion of the Investigator, available and compliant for treatment and follow-up.

Who cannot join

  • Clinical evidence of distant metastases per practice guidelines for breast cancer;
  • Inflammatory breast cancer or tumor with deep adherence or cutaneous invasion;
  • Known hypersensitivity reaction to the GM-CSF adjuvant; Any known contra-indication to GM-CSF or Cyclophosphamide treatment;
  • Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to registration and must implement adequate contraceptive measures during study treatment;
  • Active autoimmune disease requiring therapy within the past 2 years (Note: patients with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within the past 2 years are not excluded);
  • Other uncontrolled illness or medical condition, such as active infection, symptomatic heart failure (New York Heart Association class III or IV; moderate to severe objective evidence of cardiovascular disease), unstable angina pectoris, myocardial infarction or stroke within last 6 months, psychiatric illness that may limit compliance with study requirement or interfere with the understanding and giving of informed consent;
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  • Prior active secondary malignancy < 5 years prior to consent (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) or currently receiving other specific treatment for this cancer (including monoclonal antibody or pathway inhibitor);
  • Completed treatment with systemic corticosteroid or immune-modulators < 30 days prior to registration;
  • Planned treatment with other experimental drugs or any other non-hormonal anti-cancer therapy;
  • Immunocompromised patients, including patients with known HIV infection;
  • Symptomatic thyroid disease, unless negative for thyroid antibodies (TSH receptor, TPO, thyroglobulin).

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Maryland - Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Texas Oncology Presbyterian Cancer Center Dallas

    Dallas, Texas, 75231

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • MidAmerica Division,Inc

    Kansas City, Missouri, 64132

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Mount Sinai Hospital

    New York, New York, 10029

  • Montefiore Medical Center, Einstein Cancer Center

    New York, New York, 10461

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination With Folate Receptor Alpha Peptides With GM-CSF in Patients With Triple Negative Breast Cancer Defined as Primary Tumor That is Her2-neu and Low (< 10%) ER/PR Nuclear Staining

This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).

Read the detailed description

Triple negative breast cancers (TNBCs) occur in approximately 20-25% of all patients with breast cancer and are associated with a poor prognosis. Patients with TNBCs derive no benefit from targeted therapies. Excluding those patients who demonstrate a pathologic complete response following neoadjuvant chemotherapy, which is a minor fraction (i.e. 15%), overall survival is only 45% at 7 years.

Following standard of care, there are windows of opportunity to further and safely treat patients to prevent recurrence. Stimulating the immune system to produce T cells immunity specific for tumor antigens may significantly delay recurrence and cure patients.

The proposed vaccine is intended to induce T cells to survey for the reemergence of TNBCs and to prevent recurrence in the adjuvant setting. The vaccine strategy is antigen-specific and targets the Folate Receptor Alpha (FRα). FRα is an ideal target because of its limited expression in the healthy tissues and it high expression in 86% of TNBCs. Studies have shown that it is a biologically important marker that is associated with poorer clinical outcome and is retained in metastatic lesions.

The FRα vaccine include a pool of 5 peptides that are immunogenic epitopes and safely generate tissue-surveying CD4 T cell immune responses in patients tested in a recently completed phase I clinical trial.

Conditions
Breast Cancer
Being tested
Low dose FRα vaccine, Cyclophosphamide, High dose FRα vaccine
Keywords
TNBC
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Low dose FRα vaccineBiological

    Also called TPIV200

    165ug per peptide ID injection

  • CyclophosphamideDrug

    Also called Cytoxan

    IV infusion over 1 hour

  • High dose FRα vaccineBiological

    Also called TPIV200

    500ug per peptide ID injection

Study groups in NCT02593227
Study groupRoleWhat they receive
Low dose FRα vaccineExperimentalFRα peptide vaccine with GM-CSF adjuvant - single ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Receives: Biological: Low dose FRα vaccine
High dose FRα vaccineExperimentalFRα peptide vaccine with GM-CSF adjuvant - triple ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Receives: Biological: High dose FRα vaccine
Low dose FRα vaccine + cyclophosphamideExperimentalCyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRα peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Receives: Biological: Low dose FRα vaccine; Drug: Cyclophosphamide
High dose FRα vaccine + cyclophosphamideExperimentalCyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRα peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Receives: Drug: Cyclophosphamide; Biological: High dose FRα vaccine

What is being measured

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

  1. Immune response

    Emergence of B and T cell immunity targeting the folate receptor alpha

    Measured: 3 years

Secondary outcomes (3)

  1. Folate receptor alpha expression

    To determine FRα expression status of primary tumors

    Measured: Baseline

  2. Relapse Free Survival

    RFS in relation to FR specific immune response

    Measured: 3 years

  3. Safety and tolerability (treatment emergent adverse events and injection site reactions)

    Incidence of treatment emergent adverse events and injection site reactions

    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 posted2 Nov 2015 (estimated)
  2. Study startApr 2016
  3. Primary completion15 Jul 2021
  4. Study completion15 Jul 2021

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02593227
Sponsor's protocol ID
FRV-002
Status last verified
Jul 2021
First submitted
27 Oct 2015
Last updated
19 Jul 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low dose FRα vaccine, Cyclophosphamide and High dose FRα vaccine in people with Breast Cancer, run by Marker Therapeutics, Inc. at 11 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 22 inclusion and 11 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: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (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 NCT02593227.

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 19 Jul 2021.

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