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- An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009) (MK7339-009)
Clinical Trial
An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009) (MK7339-009)
The purpose of this study is to test the safety and how well the patient handles pembrolizumab taken with olaparib compared to pembrolizumab taken with carboplatin and gemcitabine. To find out wether the combination of pembrolizumab and olaparib delays progression of disease and improves survival compared to the combination of pembrolizumab with carboplatin and gemcitabine. Also, to see if pembrolizumab and olaparib compared to pembrolizumab with carboplatin and gemcitabine helps patients to have a better quality of life.
Eligibility Criteria
- Patients must have locally recurrent inoperable centrally confirmed TNBC that has notbeen previously treated with chemotherapy in the metastatic setting and that cannot be treated with currative intent. Patients must be male or female at least 18 years of age on the day of signing consent. Subjects cannot have a knownmalignancy that is progressing or has required active treatment within the past 5 years.
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