Breast Cancer Clinical Trial
Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer
This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)
Main Inclusion Criteria:
Patient has histologically proven advanced (unresectable) or metastatic cancer as outlined below according to study phase and disease type:
Phase 1 patients (breast or ovarian cancer)
Patients with advanced or metastatic breast cancer must have disease that is HER2-negative, estrogen receptor-negative, and progesterone receptor-negative (ie, TNBC). Patients with advanced or metastatic disease may have up to 4 lines of cytotoxic therapy. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.
Patients must have any epithelial (ie, serous, endometroid, mucinous, clear cell) ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have received up to 5 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.
Phase 2 patients (breast or ovarian cancer)
Patients with advanced or metastatic breast cancer must have TNBC. Patients with advanced or metastatic disease may have received up to 2 lines of cytotoxic therapy. Adjuvant and/or neoadjuvant therapies are not counted in the number of lines of therapy. TNBC patients who have previously received platinum chemotherapy in the metastatic setting are allowed to enroll in the study as long as they did not progress while on or within 8 weeks from the day of the last platinum administration.
Patients must have with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have had up to 4 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant, adjuvant, and the combination of both will be considered as one line of therapy.
Archival tumor tissue available or a fresh biopsy must be obtained prior to study treatment initiation
Measurable lesions by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) 0 or 1
Adequate organ function
Able to take oral medications
Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
Male patient agrees to use an adequate method of contraception
Main Exclusion Criteria:
Patients with primary platinum refractory ovarian cancer (ie, progressive disease on or within 6 months of first-line platinum therapy)
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis Note: Patients previously treated for brain metastases may be able to participate provided they are stable
Patient has a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer
Poor medical risk
Condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
Pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study
Immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
Known active hepatitis B or hepatitis C
Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Prior treatment with a known poly(ADP-ribose) polymerase (PARP) inhibitor
Heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening
Known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
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There are 30 Locations for this study
Birmingham Alabama, 35249, United States
Phoenix Arizona, 85054, United States
Scottsdale Arizona, 85258, United States
Los Angeles California, 90048, United States
San Francisco California, 94115, United States
Stanford California, 94305, United States
Washington District of Columbia, 20007, United States
Deerfield Beach Florida, 33442, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33136, United States
Orlando Florida, 32804, United States
Chicago Illinois, 60637, United States
Covington Louisiana, 70433, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Burlington Massachusetts, 01805, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Morristown New Jersey, 07962, United States
New York New York, 10065, United States
Chapel Hill North Carolina, 27514, United States
Charlotte North Carolina, 28204, United States
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73104, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
San Antonio Texas, 78229, United States
Charlottesville Virginia, 22903, United States
Seattle Washington, 98109, United States
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