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)

  • STATUS
    Recruiting
  • End date
    Jan 26, 2026
  • participants needed
    932
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 November 2020
Investigator
Toll Free Number
Primary Contact
Zhytomyr Regional Oncology Center ( Site 1515) (0.0 mi away) Contact
+118 other location
cancer
measurable disease
breast cancer
anthracyclines
carboplatin
pembrolizumab
triple negative breast cancer
taxane
mk-3475

Summary

The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are:

  1. Olaparib plus pembrolizumab prolongs progression-free survival (PFS) compared with chemotherapy plus pembrolizumab.
  2. Olaparib plus pembrolizumab is non-inferior to chemotherapy plus pembrolizumab in terms of overall survival (OS).
  3. Olaparib plus pembrolizumab prolongs OS compared with chemotherapy plus pembrolizumab.

Details
Treatment carboplatin, Gemcitabine, Pembrolizumab, olaparib
Clinical Study IdentifierNCT04191135
SponsorMerck Sharp & Dohme Corp.
Last Modified on25 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: or Pediatric Health or Brain Function or Metastatic Triple-Negative Breast Cancer or Recurrent Respiratory Papillomatosis or Chronic Shoulder Pain or...?
Do you have any of these conditions: or Adverse Effects, Drugs or Chronic Shoulder Pain or Triple Negative Breast Neoplasms or Near-Sighted Corrective Surgery or Recurrent Respiratory Pa...?
Do you have any of these conditions: or Injection Port or Anal Dysplasia or Primary Immunodeficiency or Breast Cancer - HER2 Positive or Diet and Nutrition or Triple Negative Breast Neop...?
Do you have any of these conditions: or Brain Function or Pediatric Health or Triple Negative Breast Cancer or Chronic Diarrhea or Recurrent Respiratory Papillomatosis or Metastatic Trip...?
Do you have any of these conditions: or Chronic Diarrhea or Peripheral Arterial Occlusive Disease or Chronic Shoulder Pain or Skin Wounds or Diet and Nutrition or Pediatric Health or Vag...?
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
A male participant must agree to be abstinent or use contraception and refrain from donating sperm during the intervention period and for at least 180 days after the last dose of study treatment
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 180 days after the last dose of study treatment
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

Exclusion Criteria

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 that required steroids or current pneumonitis
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 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 a resting electrocardiogram (ECG) indicating 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
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