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A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT02779751)

Merck Sharp & Dohme Corp.
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.
  • Drug: Abemaciclib
    Administered orally
    • LY2835219
  • Drug: Pembrolizumab
    Administered IV
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Have a Stage IV diagnosis of 1 of the following: Part A: NSCLC (Kirsten rat sarcoma mutant [KRAS mt], PD-L1+); Part B: NSCLC (squamous histology); or Part C: metastatic breast cancer (HR+, HER2-).
    • Part A: must be chemotherapy naïve for metastatic NSCLC
    • Part B: must have received at least 1 prior therapy containing platinum-based chemotherapy for advanced/metastatic NSCLC
    • Part C: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting
    • Are amenable to provide tumor tissue prior to treatment and provide tumor tissue after treatment initiation (both mandatory).
    • Have presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
    • Have a performance status (PS) ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
    • Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
    • Have an estimated life expectancy of ≥12 weeks.
    Exclusion Criteria:
    • Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: subjects with controlled atrial fibrillation for >30 days prior to study treatment are eligible.
    • Have central nervous system (CNS) metastasis with development of associated neurological changes 14 days prior to receiving study drug.
    • Have corrected QT interval of >470 milliseconds on screening electrocardiogram (ECG).
    • Have history of interstitial lung disease or pneumonitis.
    • Have history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years.
    • Have received a live vaccination within 30 days of study start.
    • Have received prior treatment with an anti PD-1, anti-programmed death ligand 1 (PD-L1), or anti cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.

    27 locations

    Status:
    recruiting
    Type:
    Interventional
    Phase:
    Start:
    13 November, 2016
    Updated:
    21 February, 2018
    Participants:
    75
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