Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)
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Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Induction Period:
Has locally recurrent inoperable TNBC that has not previously been treated with chemotherapy and that cannot be treated with curative intent OR has metastatic TNBC that has not been previously treated with chemotherapy
Has been treated with anthracycline and/or a taxane in the neoadjuvant/adjuvant setting, if they received systemic treatment in the neoadjuvant/adjuvant setting, unless anthracycline and/or taxane was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician
Has measurable disease based on RECIST 1.1
Has provided a recently obtained or archival (no more than 3 years old) core or excisional biopsy of a tumor lesion not previously irradiated
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 7 days prior to the start of induction study treatment
Has a life expectancy ≥27 weeks from the day of first study treatment
Demonstrate adequate organ function within 10 days prior to the start of study treatment
A male participant must agree to be abstinent or use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention (95 days for olaparib and chemotherapy; no requirement for pembrolizumab)
A female participant must not be pregnant or breastfeeding and must agree to the following if is a woman of childbearing potential (WOCBP): have a negative pregnancy test within 24 hours before the start of study treatment and agree to be abstinent or use contraception and refrain from donating eggs (ova, oocytes) during the intervention period and for at least the time needed to eliminate each study intervention (180 days for olaparib and chemotherapy; 120 days for pembrolizumab)
Post-induction Period:
Has received up to 6 cycles but not less than 4 cycles of induction therapy without permanently discontinuing from pembrolizumab or both carboplatin and gemcitabine
Has achieved complete response (CR), partial response (PR), or stable disease (SD) based on RECIST 1.1 by Blinded Independent Central Review (BICR) at the Week 18 evaluation
Is able to complete during post-induction at least the Cycle 1, Day 1 doses of olaparib and pembrolizumab or the Cycle 1, Day 1 doses of at least one of the chemotherapy agents being administered at the end of induction (carboplatin and/or gemcitabine) in addition to pembrolizumab
Has ECOG performance status of 0 or 1, as assessed within 7 days prior to the start of post-induction study treatment
Has no higher than Grade 1 toxicities related to induction therapy (excluding alopecia) prior to randomization
You may not be if
Induction Period:
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
Has a history of (non-infectious) pneumonitis\\interstitial lung disease that required steroids or current pneumonitis\\interstitial lung disease
Has active, or a history of, interstitial lung disease
Has a known history of active tuberculosis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection
Has a history of class II-IV congestive heart failure or myocardial infarction within 6 months of first study treatment
Has neuropathy ≥Grade 2
Has not recovered (eg, to ≤Grade 1 or to baseline) from AEs due to a previously administered therapy
Has a known history of hypersensitivity or allergy to pembrolizumab, olaparib and any of its components, and/or to any of the study chemotherapies (eg, carboplatin or gemcitabine) and any of their components
Has severe hypersensitivity (≥Grade 3) to the study treatments and/or any of their excipients
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 180 days after the last dose of study treatment
Is a WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation
Has received prior therapy with either olaparib or any other poly adenosine diphosphate ribose polymerase (PARP) inhibitor
Has received prior radiotherapy within 2 weeks of start of study treatment
Has received colony-stimulating factors (eg, granulocyte colony stimulating factor \[G-CSF\], granulocyte macrophage colony stimulating factor \[GM-CSF\] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment
Has had an allogenic tissue/solid organ transplant.
Has received previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT)
Has had major surgery within 2 weeks of starting study treatment or has not recovered from any effects of any major surgery
Has received a live or live-attenuated vaccine within 30 days prior to first study treatment
Is receiving any medication prohibited in combination with study chemotherapies unless medication was stopped within 7 days prior to first study treatment
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 (such as cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137) or has previously participated in a study evaluating pembrolizumab regardless of treatment received
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator
Has a history or current evidence of any condition (eg, cytopenia, transfusion-dependent anemia, or thrombocytopenia), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator
Is either unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption)
Is unlikely to comply with the study procedures, restrictions, and requirements of the study; as judged by the investigator
Post-induction Period:
Has severe hypersensitivity (≥Grade 3) to the study treatments and/or any of their excipients
Has permanently discontinued from both carboplatin and gemcitabine during induction due to toxicity
Has permanently discontinued from pembrolizumab during induction due to toxicity
Has received less than 4 cycles of chemotherapy plus pembrolizumab during induction
Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Is currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study
Clareo Health | Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)
