CDK4/6 Inhibitor
Abemaciclib
Phase
1
Not Enrolling
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*
Related Resources:
Key Inclusion Criteria
- Stage IV non-small cell lung cancer (NSCLC) or hormone-receptor-positive (HR+), HER2-negative breast cancer
- Part A: Chemotherapy-naïve, KRAS-mutant, PD-L1-positive NSCLC
- Part B: Squamous NSCLC. Participants must have received only one prior platinum-based chemotherapy for advanced/metastatic NSCLC
- Part C: HR+, HER2-negative breast cancer. Participants must have received at least one, but no more than two, chemotherapy regimens in the metastatic setting
- Part D: Locally advanced or metastatic HR+, HER2-negative breast cancer
- Willing to provide tumor tissue prior to treatment and after treatment initiation
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Must agree to use highly effective methods of contraception during the study and for 120 days following last dose of study drug
- Discontinued all previous treatments for cancer and recovered from the acute effects of therapy
- Life expectancy of ≥12 weeks
Key Exclusion Criteria
- Part D: Currently receiving or previously received endocrine therapy OR chemotherapy for locoregionally recurrent or metastatic breast cancer. Initiated bisphosphonates or approved RANK-ligand (RANK-L) targeted agents <7 days prior to cycle 1 day 1
- History of syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
- Central nervous system metastasis with development of associated neurological changes 14 days prior to receiving study drug
- History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast) unless in complete remission with no therapy for a minimum of 3 years
- Pregnant, breastfeeding, or expecting to conceive or father children within the duration of the trial through 4 months after last dose of trial treatment
- QTc interval >470 ms on electrocardiogram
- History of interstitial lung disease
- History of or active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years
- Prior anti-PD-1, anti-PD-L1, or anti-CTLA4 agent
- Prior therapy with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor
- Active bacterial, fungal, and/or known viral infection
*
This clinical trial is being conducted globally in partnership with Merck Sharp & Dohme Corp.
†
Abemaciclib is administered PO Q12H on days 1-21 of each 21-day cycle.
‡
Pembrolizumab is administered intravenously on day 1 of each 21-day cycle.
§
Anastrozole is administered PO Q24H on days 1-21 of each 21-day cycle.
