Clinical Trials /

Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy

NCT02411656

Description:

This phase II trial studies how well pembrolizumab works in treating patients with stage IV inflammatory breast cancer or triple-negative breast cancer that has spread to other places in the body (metastatic) or has come back (recurrent), and who have achieved clinical response or stable disease to prior chemotherapy. 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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">MK-3475</span> for Metastatic Inflammatory <span class="go-doc-concept go-doc-disease">Breast Cancer</span> (MIBC)

Title

  • Brief Title: MK-3475 for Metastatic Inflammatory Breast Cancer (MIBC)
  • Official Title: A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer Who Have Received Prior Chemotherapy With Clinical Response
  • Clinical Trial IDs

    NCT ID: NCT02411656

    ORG ID: 2014-0533

    NCI ID: NCI-2015-00671

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    MK-3475 Keytruda, Pembrolizumab, SCH-900475 MK-3475

    Trial Purpose

    The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475
    and Keytruda) can help to control metastatic IBC. The safety of this drug will also be
    studied.

    Detailed Description

    Study Drug Administration:

    If you are found to be eligible to take part in this study, you will receive pembrolizumab
    by vein over about 30 minutes on Day 1 (+/- 3 days) of each 21-day cycle.

    Study Visits:

    On Day 1 of each cycle:

    - You will have a physical exam.

    - Blood (about 2 tablespoons) will be drawn for routine tests.

    At Cycles 3, every 3rd cycle after that (Cycles 6, 9, 12, and so on), and if the disease
    gets worse, blood (about 10 tablespoons) will be drawn for biomarker and immune system
    testing.

    About every 2 Cycles, you will have imaging scans to check the status of the disease as part
    of standard of care.

    Length of Study:

    You may continue taking the study drug for up to 24 months, as long as the doctor thinks it
    is in your best interest. You will no longer be able to take the study drug if the disease
    gets worse, if intolerable side effects occur, or if you are unable to follow study
    directions.

    Your participation on the study will be over after the follow-up visits.

    End-of-Treatment Visit

    After you stop receiving the study drug:

    - You will have a physical exam.

    - Blood (about 10 tablespoons) will be drawn for routine tests.

    - You will have the same imaging scans you had at screening to check the status of the
    disease.

    Follow-Up:

    About 1 and 3 months after the last dose of study drug, you will be asked about your health
    and any side effects you may have had. You may be asked during a routine clinic visit or
    you may be called. If you are called, each call should last about 2 minutes.

    This is an investigational study. Pembrolizumab is FDA approved and commercially available
    for the treatment of metastatic melanoma. Its use in patients with metastatic IBC is
    investigational. The study doctor can describe how the study drug is designed to work.

    Up to 35 participants will be enrolled in this study. All will take part in at MD Anderson.

    Trial Arms

    Name Type Description Interventions
    MK-3475 Experimental MK-3475 200 mg administered on Day 1 of each 21 day cycle as a 30 minute infusion by vein. Participant may continue taking the study drug for up to 24 months. About 1 and 3 months after last dose of study drug, participant to have follow up or phone call. If participant is called, each call should last about 2 minutes. MK-3475

    Eligibility Criteria

    Inclusion Criteria:

    1. Is willing and able to provide written informed consent for the trial.

    2. Is a female or male and >/= 18 years of age

    3. Has histological confirmation of breast carcinoma with a clinical diagnosis of IBC
    based on presence of inflammatory changes in the involved breast, including diffuse
    erythema and edema (peau d'orange), with or without an underlying palpable mass
    involving the majority of the skin of the breast. Pathological evidence of dermal
    lymphatic invasion should be noted but is not required for diagnosis of inflammatory
    breast cancer

    4. Has stage IV or recurrent disease after treated primary IBC.

    5. Has clinical response after receiving the first line or second line chemotherapy for
    metastatic disease. A minimum of two cycles (6-8 weeks) of chemotherapy is required
    to determine clinical response. The response should be confirmed by repeat
    assessments that should be performed no less than 4 weeks after the criteria for
    response are first met. Per RECIST criteria 1.1, Clinical response for measurable
    disease is defined as complete response (CR) or partial response (PR); for
    non-measurable disease only (i.e. bone metastasis, ascites, pleural effusion, and
    pathological lymph nodes >/= 10 to <15 mm short axis) is defined as persistence of
    one or more non-target lesion(s) and no increase in overall tumor burden.

    6. Is HER2 normal, defined as HER2 0 or 1+ by IHC and negative by FISH if performed; or
    HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not
    performed.

    7. Has a performance status of 0-1 on the ECOG Performance Scale.

    8. Has adequate organ function as determined by the following laboratory values: ANC >/=
    1,500 /mcL, Platelets >/=100,000 /mcL, Hgb >/= 9 g/dL, creatinine levels < 1.5 x ULN,
    Total bilirubin </= 1.5 x ULN, ALT and AST </= 2.5 x ULN or </=5 x ULN for subjects
    with liver metastases.

    9. Subjects of childbearing potential should be willing to use effective methods of
    birth control or be surgically sterile, or abstain from heterosexual activity for the
    course of the study through at least 4 months after the last dose of study
    drug.Subjects of childbearing potential are those who have not been surgically
    sterilized or have not been free from menses for > 1 year. Effective methods of birth
    control include 1). Use of hormonal birth control methods: pills, shots/injections,
    implants (placed under the skin by a health care provider), or patches (placed on the
    skin); 2).Intrauterine devices (IUDs); 3).Using 2 barrier methods (each partner must
    use 1 barrier method) with a spermicide. Males must use the male condom (latex or
    other synthetic material) with spermicide. Females must choose either a Diaphragm
    with spermicide, or Cervical cap with spermicide, or a sponge (spermicide is already
    in the contraceptive sponge).

    10. Has negative serum or urine pregnancy test for subjects of childbearing potential.

    Exclusion Criteria:

    1. Is currently participating in a study of an investigational anti-cancer agent.

    2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
    other form of immunosuppressive therapy.

    3. Has not recovered from adverse events due to prior therapies, i.e. monoclonal
    antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or
    surgery.( Note: Subjects with Grade 2 neuropathy, alopecia and general disorders
    and administration site conditions (per CTCAE version 4.0) are an exception to this
    criterion and may qualify for the study.)

    4. Has a known malignancy (other than breast cancer) except basal cell carcinoma or
    squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone
    potentially curative therapy.

    5. Has known active central nervous system (CNS) metastases and/or carcinomatous
    meningitis. Subjects with previously treated brain metastases may participate if they
    are stable, and have no evidence of new or enlarging brain metastases, and are not
    using steroids for at least 7 days prior to trial treatment.

    6. Has an active autoimmune disease requiring systemic treatment within the past 3
    months or a documented history of clinically severe autoimmune disease, or a syndrome
    that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo
    or resolved childhood asthma/atopy would be an exception to this rule. Subjects that
    require intermittent use of bronchodilators or local steroid injections would not be
    excluded from the study. Subjects with hypothyroidism stable on hormone replacement
    or Sjorgen's syndrome will not be excluded from the study.

    7. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.

    8. Has an active infection requiring systemic therapy.

    9. Has known psychiatric or substance abuse disorders that would interfere with
    cooperation with the requirements of the trial.

    10. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
    anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including
    ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation
    or checkpoint pathways).

    11. Has a known history of Human Immunodeficiency Virus (HIV).

    12. Has a known active Hepatitis B or Hepatitis C

    13. Have received a live vaccine within 30 days prior to the first dose of trial
    treatment.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Disease Control Rate

    Secondary Outcome Measures

    Trial Keywords

    Breast cancer

    Metastatic inflammatory breast cancer

    MIBC

    IBC

    Breast carcinoma

    Metastatic

    MK-3475

    Keytruda

    Pembrolizumab

    SCH-900475