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NCT04191135

PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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 is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS). 2. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS). As of Amendment 3, study enrollment was discontinued. Participants who were receiving benefit from the study intervention could continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

462

Start Date

2019-12-19

Completion Date

2025-11-26

Last Updated

2026-09-14

Healthy Volunteers

Conditions

Triple Negative Breast Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab

intravenous (IV) infusion

DRUG

Olaparib

oral tablets

DRUG

Carboplatin

IV infusion

DRUG

Gemcitabine

IV infusion

Inclusion Criteria: 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 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\\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

Locations (122)

Pacific Cancer Care ( Site 0142)

Monterey, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)

San Francisco, California, United States

John Wayne Cancer Institute ( Site 0111)

Santa Monica, California, United States

St. Joseph Heritage Healthcare ( Site 0104)

Santa Rosa, California, United States

University of Miami Sylvester CC ( Site 0146)

Miami, Florida, United States

Georgia Cancer Center at Augusta University ( Site 0129)

Augusta, Georgia, United States

University of Chicago ( Site 0159)

Chicago, Illinois, United States

Massachusetts General Hospital ( Site 0155)

Boston, Massachusetts, United States

Henry Ford Health System ( Site 0103)

Detroit, Michigan, United States

Virginia Piper Cancer Institute ( Site 0157)

Minneapolis, Minnesota, United States

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161)

Middletown, New Jersey, United States

MSKCC-Bergen ( Site 0162)

Montvale, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160)

Commack, New York, United States

Memorial Sloan-Kettering Cancer Center ( Site 0156)

New York, New York, United States

Mercy Clinic Oncology and Hematology ( Site 0110)

Oklahoma City, Oklahoma, United States

The Center For Cancer And Blood Disorders ( Site 0151)

Fort Worth, Texas, United States

Texas Oncology-New Braunfels ( Site 0168)

New Braunfels, Texas, United States

Texas Oncology-San Antonio Northeast ( Site 0165)

San Antonio, Texas, United States

Texas Oncology-San Antonio Medical Center ( Site 0158)

San Antonio, Texas, United States

Texas Oncology - San Antonio Stone Oak ( Site 0166)

San Antonio, Texas, United States

Renovatio Clinical ( Site 0117)

The Woodlands, Texas, United States

Virginia Oncology Associates ( Site 0163)

Newport News, Virginia, United States

Virginia Oncology Associates ( Site 0153)

Norfolk, Virginia, United States

Virginia Oncology Associates ( Site 0164)

Virginia Beach, Virginia, United States

YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128)

Yakima, Washington, United States

Princess Margaret Cancer Centre ( Site 0005)

Toronto, Ontario, Canada

CSSS de Laval- Hopital de la Cite de la Sante ( Site 0011)

Laval, Quebec, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0003)

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0010)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0002)

Montreal, Quebec, Canada

Centro Investigación del Cáncer James Lind ( Site 0510)

Temuco, Araucania, Chile

IC La Serena Research ( Site 0511)

La Serena, Coquimbo Region, Chile

Fundacion Arturo Lopez Perez ( Site 0500)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 0501)

Santiago, Region M. de Santiago, Chile

Oncocentro ( Site 0502)

Viña del Mar, Valparaiso, Chile

Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601)

Medellín, Antioquia, Colombia

Clinica de la Costa Ltda. ( Site 0600)

Barranquilla, Atlántico, Colombia

Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0609)

Barranquilla, Atlántico, Colombia

Oncomedica S.A. ( Site 0606)

Montería, Departamento de Córdoba, Colombia

Fundacion Valle del Lili ( Site 0602)

Cali, Valle del Cauca Department, Colombia

Hemato Oncologos S.A. ( Site 0603)

Cali, Valle del Cauca Department, Colombia

Centre Francois Baclesse ( Site 1012)

Caen, Calvados, France

CHU-Jean Minjoz ( Site 1013)

Besançon, Doubs, France

Institut Claudius Regaud IUCT Oncopole ( Site 1001)

Toulouse, Haute-Garonne, France

Centre de Cancerologie du Grand Montpellier ( Site 1009)

Montpellier, Languedoc-Roussillon, France

CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 1007)

Metz, Moselle, France

Centre Jean Perrin ( Site 1003)

Clermont-Ferrand, Puy-de-Dome, France

Centre Leon Berard ( Site 1018)

Lyon, Rhone, France

Centre Henri Becquerel ( Site 1020)

Rouen, Seine-Maritime, France

CHU Amiens Hopital Sud ( Site 1023)

Amiens, Somme, France

Institut Gustave Roussy ( Site 1010)

Villejuif, Val-de-Marne, France

Institut Sainte Catherine ( Site 1026)

Avignon, Vaucluse, France

Hôpital Saint-Louis ( Site 1025)

Paris, France

Universitaetsklinikum Mannheim GmbH ( Site 1213)

Mannheim, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen ( Site 1201)

Erlangen, Bavaria, Germany

Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe ( Site 1200)

Munich, Bavaria, Germany

Hochwaldkrankenhaus Bad Nauheim ( Site 1211)

Bad Nauheim, Hesse, Germany

Sana Klinikum Offenbach Klinik fuer Gynakologie und Geburtshilfe ( Site 1206)

Offenbach, Hesse, Germany

Gynaekologisch-onkologische Praxis Hannover ( Site 1207)

Hanover, Lower Saxony, Germany

Gynaekologisches Zentrum-Schwerpunkt Gyn. Onkologie ( Site 1205)

Bonn, North Rhine-Westphalia, Germany

Universitaetsklinikum AoeR Duesseldorf ( Site 1210)

Düsseldorf, North Rhine-Westphalia, Germany

Kliniken Essen-Mitte ( Site 1215)

Essen, North Rhine-Westphalia, Germany

Frauenklinik St. Louise ( Site 1216)

Paderborn, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus ( Site 1203)

Dresden, Saxony, Germany

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 1607)

Pécs, Baranya, Hungary

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1608)

Kecskemét, Bács-Kiskun county, Hungary

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1601)

Szolnok, Jász-Nagykun-Szolnok, Hungary

Zala Megyei Szent Rafael Korhaz ( Site 1605)

Zalaegerszeg, Zala County, Hungary

Orszagos Onkologiai Intezet ( Site 1602)

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 1600)

Debrecen, Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1604)

Kaposvár, Hungary

Cork University Hospital ( Site 0902)

Cork, Ireland

St Vincents University Hospital ( Site 0900)

Dublin, Ireland

Aichi Cancer Center Hospital ( Site 2202)

Nagoya, Aichi-ken, Japan

Hyogo College of Medicine Hospital ( Site 2203)

Nishinomiya, Hyōgo, Japan

Fukushima Medical University Hospital ( Site 2201)

Fukushima, Japan

Hiroshima City Hiroshima Citizens Hospital ( Site 2204)

Hiroshima, Japan

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research (Site 2200)

Osaka, Japan

Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 1909)

Pleszew, Greater Poland Voivodeship, Poland

Pratia MCM Krakow ( Site 1919)

Krakow, Lesser Poland Voivodeship, Poland

Regionalny Szpital Specjalistyczny Latawiec ( Site 1917)

Swidnica, Lower Silesian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (Site 1908)

Warsaw, Masovian Voivodeship, Poland

Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1913)

Gdynia, Pomeranian Voivodeship, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1912)

Gliwice, Silesian Voivodeship, Poland

National Cancer Center ( Site 2406)

Goyang-si, Kyonggi-do, South Korea

Seoul National University Bundang Hospital ( Site 2409)

Seongnam-si, Kyonggi-do, South Korea

Ajou University Hospital ( Site 2407)

Suwon, Kyonggi-do, South Korea

Kyungpook National University Chilgok Hospital ( Site 2402)

Daegu, Taegu-Kwangyokshi, South Korea

Gachon University Gil Medical Center ( Site 2408)

Incheon, South Korea

Seoul National University Hospital ( Site 2403)

Seoul, South Korea

Severance Hospital Yonsei University Health System ( Site 2401)

Seoul, South Korea

Asan Medical Center ( Site 2404)

Seoul, South Korea

Samsung Medical Center ( Site 2405)

Seoul, South Korea

Hospital Universitario Reina Sofia ( Site 0705)

Córdoba, Andalusia, Spain

Hospital General Arnau de Vilanova de Valencia ( Site 0706)

Valencia, Valenciana, Comunitat, Spain

Instituto Oncologico Baselga.Hospital Quiron. ( Site 0707)

Barcelona, Spain

Hospital Universitari Vall d Hebron ( Site 0701)

Barcelona, Spain

Hospital Clinic I Provincial de Barcelona ( Site 0702)

Barcelona, Spain

Clinica Universitaria Navarra - Madrid ( Site 0700)

Madrid, Spain

Kaohsiung Chang Gung Memorial Hospital ( Site 2304)

Kaohsiung City, Taiwan

National Cheng Kung University Hospital ( Site 2303)

Tainan, Taiwan

MacKay Memorial Hospital ( Site 2301)

Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center ( Site 2300)

Taipei, Taiwan

China Medical University Hospital ( Site 2302)

Taipei, Taiwan

Chernihiv Medical Center of Modern Oncology ( Site 1520)

Chernihiv, Chernihiv Oblast, Ukraine

Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 1502)

Dnipro, Dnipropetrovsk Oblast, Ukraine

CI Krivorizhskiy oncology dispensery ( Site 1504)

Kryviy Rih, Dnipropetrovsk Oblast, Ukraine

MI Precarpathian Clinical Oncology Center ( Site 1506)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1508)

Kharkiv, Kharkiv Oblast, Ukraine

Communal non profit enterprise Regional Clinical Oncology Center ( Site 1512)

Kharkiv, Kharkiv Oblast, Ukraine

SI-Zaytsev institute of general and urgent surgery-NAMS ( Site 1518)

Kharkiv, Kharkiv Oblast, Ukraine

Medical Centre Consilium Medical ( Site 1514)

Kyiv, Kyivska Oblast, Ukraine

Medical center of the Limited Liability Company Yulis ( Site 1517)

Zaporizhzhya, Zaporizhzhia Oblast, Ukraine

Medical Centre LLC Oncolife ( Site 1510)

Zaporizhzhya, Zaporizhzhia Oblast, Ukraine

Zhytomyr Regional Oncology Center ( Site 1515)

Zhytomyr, Zhytomyr Oblast, Ukraine

Medical Center Verum ( Site 1501)

Kyiv, Ukraine

Raigmore Hospital ( Site 0915)

Inverness, Highland, United Kingdom

Blackpool Victoria Hospital ( Site 0921)

Blackpool, Lancashire, United Kingdom

Barts Health NHS Trust ( Site 0912)

London, London, City of, United Kingdom

North West Cancer Centre ( Site 0922)

Londonderry, London, City of, United Kingdom

Musgrove Park Hospital ( Site 0918)

Taunton, Somerset, United Kingdom

The Christie NHS Foundation Trust ( Site 0914)

Manchester, United Kingdom

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (122)