Clinical Trials /

Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

NCT02435680

Description:

To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Efficacy Study of <span class="go-doc-concept go-doc-intervention">MCS110</span> Given With <span class="go-doc-concept go-doc-intervention">Carboplatin</span> and <span class="go-doc-concept go-doc-intervention">Gemcitabine</span> in Advanced Triple Negative <span class="go-doc-concept go-doc-disease">Breast Cancer</span> (TNBC)

Title

  • Brief Title: Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
  • Official Title: A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
  • Clinical Trial IDs

    NCT ID: NCT02435680

    ORG ID: CMCS110Z2201

    NCI ID: 2015-000179-29

    Trial Conditions

    Advanced Triple Negative Breast Cancer (TNBC) With High TAMs

    Trial Interventions

    Drug Synonyms Arms
    MCS110 Arm 1: MCS110+carboplatin+gemcitabine
    carboplatin Arm 1: MCS110+carboplatin+gemcitabine, Arm 2: carboplatin+gemcitabine
    gemcitabine Arm 1: MCS110+carboplatin+gemcitabine, Arm 2: carboplatin+gemcitabine

    Trial Purpose

    To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and
    gemcitabine (carbo/gem) in advanced TNBC patients

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm 1: MCS110+carboplatin+gemcitabine Experimental MCS110+carboplatin+gemcitabine MCS110, carboplatin, gemcitabine
    Arm 2: carboplatin+gemcitabine Active Comparator carboplatin+gemcitabine carboplatin, gemcitabine

    Eligibility Criteria

    Inclusion Criteria:

    - Adult women ( 18 years of age) with advanced TNBC.

    - Histological or cytological evidence of estrogen-receptor negative (ER-),
    progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor
    negative (HER2-) Breast Cancer by local laboratory testing, based on last available
    tumor tissue.

    - ER/PgR negativity to follow local guidelines

    - If IHC HER2 2+, a negative FISH test is required

    - A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the
    central laboratory (approximately 15% of TAMs or above).

    - Patients must have:

    At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or
    mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that
    meets the measurability criteria)

    Exclusion Criteria:

    - Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is
    allowed.

    - Therapy for underlying malignancy within 2 weeks prior to start of study treatment:

    - Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)

    - Radiotherapy

    - Major surgery

    - Patients receiving concomitant immunosuppressive agents or chronic corticosteroids
    (10 mg of prednisone or equivalent) at the time of first study dose.

    - Clinically significant cardiovascular disease such as uncontrolled or symptomatic
    arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
    screening.

    - Known history of human immunodeficiency virus or active infection with hepatitis
    virus or any uncontrolled active systemic infection.

    - Patients with the following laboratory values during screening and on Day 1 predose:

    - Absolute Neutrophil Count (ANC) < 1.0x109/L

    - Hemoglobin < 9 g/dL

    - Platelets < 100x109/L

    - Serum creatinine > 1.5 x ULN

    - Serum total bilirubin > 1.5 x ULN

    - AST/SGOT and ALT/SGPT > 3.0 x ULN

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Progression free survival (PFS) as per RECIST v1.1 (by local investigator assessment)

    Secondary Outcome Measures

    Number of participants with adverse events and serioaus adverse events

    Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters

    Serum concentration of free MCS110 and derived Pharmacokinetics (PK) parameters

    Plasma concentration of carboplatin, gemcitabine and 2',2'-difluoro-deoxyuridine (dFdU)

    Total Colony stimulation factor -1 (CSF-I) circulating levels, serum C-terminal telopeptide of type I collagen (CTX-I) and circulating monocytes

    Tumor associated macrophage (TAM) and Tumor infiltrating lymphocyte (TIL) content in pre- and post-dose tumor biopsies

    Tumor response per RECIST v1.1 (by local investigator assessment)

    Trial Keywords

    MCS110; carboplatin; gemcitabine; TNBC; TAMs