Status and phase
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About
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)
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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)
Phase 2 patients (breast or ovarian cancer)
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:
Primary purpose
Allocation
Interventional model
Masking
122 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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