Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer (NCT04373031) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer
United States12 participantsStarted 2020-12-30
Plain-language summary
This is a Phase II, randomized, open-label trial to evaluate the clinical and immunologic activity of pembrolizumab plus chemotherapy when combined with various immunotherapy induction regimens as neoadjuvant therapy for triple negative breast cancer (TNBC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
✓. Be a male or female subject greater than or equal to 18 years of age on day of signing informed consent.
✓. Have locally confirmed TNBC, as defined by the most recent ASCO/CAP guidelines.
✓. Have previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per the current AJCC Version 8 staging criteria for breast cancer staging criteria as assessed by the investigator based on radiological and/or clinical assessment:
✓. Provide a core needle biopsy consisting of at least 1 separate tumor-bearing cores from the primary tumor at screening for translational research (archival is acceptable if sufficient tumor is available; slides are acceptable if at least 15 are available)
✓. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 14 days of treatment initiation.
✓. Demonstrate adequate organ function. All screening labs should be performed within 14 days of treatment initiation.
✓. Have left ventricular ejection fraction (LVEF) of ≥50% or ≥ institution lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.
Exclusion criteria
✕. Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
✕. Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) or has previously participated in MK-3475 clinical trials.
✕. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 4 weeks of the first dose of treatment in this current trial.
✕. Has received a live vaccine within 30 days of the first dose of study treatment.
✕. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
✕. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
✕. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).