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)

• ClinicalTrials.gov Identifier: NCT04191135
• Recruitment Status: Active, not recruiting
• First Posted: December 9, 2019
• Last Update Posted: October 12, 2022
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Triple Negative Breast Neoplasms	Biological: Pembrolizumab; Drug: Olaparib; Drug: Carboplatin; Drug: Gemcitabine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 460 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: December 19, 2019
• Estimated Primary Completion Date: January 26, 2026
• Estimated Study Completion Date: January 26, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: pembrolizumab + carboplatin and gemcitabine; Participants receive both carboplatin Area Under The Curve (AUC) 2 with gemcitabine 1000 mg/m^2 intravenously on Days 1 and 8 of each 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle during the induction period for 4-6 cycles. After the induction period, participants will continue to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.	Biological: Pembrolizumab; intravenous (IV) infusion; Other Names: KEYTRUDA®; MK-3475; Drug: Carboplatin; IV infusion; Other Name: PARAPLATIN®; Drug: Gemcitabine; IV infusion; Other Name: GEMZAR®
Experimental: pembrolizumab + olaparib; Participants receive both carboplatin AUC 2 with gemcitabine 1000 mg/m^2 intravenously on Days 1 and 8 of each 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle during the induction period for 4-6 cycles. After the induction period, participants will receive pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Biological: Pembrolizumab; intravenous (IV) infusion; Other Names: KEYTRUDA®; MK-3475; Drug: Olaparib; oral tablets; Other Names: LYNPARZA®; MK-7339; AZD2281; KU-0059436; Drug: Carboplatin; IV infusion; Other Name: PARAPLATIN®; Drug: Gemcitabine; IV infusion; Other Name: GEMZAR®

Outcome Measures

Primary Outcome Measures :

1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 72 months ]
   PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
2. Overall Survival (OS) [ Time Frame: Up to approximately 72 months ]
   OS is the time from randomization to death due to any cause.

Secondary Outcome Measures :

1. Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors with a Combined Positive Score (CPS) ≥10 [ Time Frame: Up to approximately 72 months ]
   OS is the time from randomization to death due to any cause.
2. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors with a Combined Positive Score (CPS) ≥10 [ Time Frame: Up to approximately 72 months ]
   PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
3. Overall Survival (OS) in Participants with Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors [ Time Frame: Up to approximately 72 months ]
   OS is the time from randomization to death due to any cause.
4. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants with Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors [ Time Frame: Up to approximately 72 months ]
   PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
5. Change From Baseline in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score [ Time Frame: Baseline and up to approximately 72 months ]
   The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
6. Change From Baseline in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1- 5 Score [ Time Frame: Baseline and up to approximately 72 months ]
   The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
7. Change From Baseline in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score [ Time Frame: Baseline and up to approximately 72 months ]
   The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 4 questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in emotional functioning (EORTC QLQ-C30 Items 21-24) score will be presented.
8. Change From Baseline in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life (QoL) Questionnaire (EORTC QLQ-BR23) Items 1-4, 6, 7, and 8 Score [ Time Frame: Baseline and up to approximately 72 months ]
   EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score will be presented.
9. Time to Deterioration in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score [ Time Frame: Up to approximately 72 months ]
   The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores.
10. Time to Deterioration in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1- 5 Score [ Time Frame: Up to approximately 72 months ]
    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores.
11. Time to Deterioration in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score [ Time Frame: Up to approximately 72 months ]
    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 4 questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in emotional functioning Items 21-24 scale scores.
12. Time to Deterioration in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life (QoL) Questionnaire (EORTC QLQ-BR23) Items 1-4, 6, 7, and 8 Score [ Time Frame: Up to approximately 72 months ]
    EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in systemic therapy side effects Items 1-4, 6, 7 and 8 scale scores.
13. Change From Baseline in Health Outcomes using the European Quality of Life 5-dimension, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score [ Time Frame: Baseline and up to approximately 72 months ]
    The EQ-5D-5L measured health-related outcomes, assessing 5 health state dimensions (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates their general state of health. The change from baseline in EQ-5D-5L score will be presented.
14. Number of Participants Who Experienced At Least One Adverse Event (AE) [ Time Frame: Up to approximately 72 months ]
    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.
15. Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 72 months ]
    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Pacific Cancer Care ( Site 0142)

Monterey, California, United States, 93940

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)

San Francisco, California, United States, 94158

John Wayne Cancer Institute ( Site 0111)

Santa Monica, California, United States, 90404

St. Joseph Heritage Healthcare ( Site 0104)

Santa Rosa, California, United States, 95403

United States, Florida

University of Miami Sylvester CC ( Site 0146)

Miami, Florida, United States, 33136

United States, Georgia

Georgia Cancer Center at Augusta University ( Site 0129)

Augusta, Georgia, United States, 30912

United States, Illinois

University of Chicago ( Site 0159)

Chicago, Illinois, United States, 60637

United States, Massachusetts

Massachusetts General Hospital ( Site 0155)

Boston, Massachusetts, United States, 02114

United States, Michigan

Henry Ford Health System ( Site 0103)

Detroit, Michigan, United States, 48202

United States, Minnesota

Virginia Piper Cancer Institute ( Site 0157)

Minneapolis, Minnesota, United States, 55407

United States, New Jersey

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161)

Middletown, New Jersey, United States, 07748

MSKCC-Bergen ( Site 0162)

Montvale, New Jersey, United States, 07645

United States, New York

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

Commack, New York, United States, 11725

Memorial Sloan-Kettering Cancer Center ( Site 0156)

New York, New York, United States, 10065

United States, Oklahoma

Mercy Clinic Oncology and Hematology ( Site 0110)

Oklahoma City, Oklahoma, United States, 73120

United States, Texas

The Center For Cancer And Blood Disorders ( Site 0151)

Fort Worth, Texas, United States, 76104

Texas Oncology-New Braunfels ( Site 0168)

New Braunfels, Texas, United States, 78130

Texas Oncology-San Antonio Northeast ( Site 0165)

San Antonio, Texas, United States, 78217

Texas Oncology-San Antonio Medical Center ( Site 0158)

San Antonio, Texas, United States, 78240

Texas Oncology - San Antonio Stone Oak ( Site 0166)

San Antonio, Texas, United States, 78258

Renovatio Clinical ( Site 0117)

The Woodlands, Texas, United States, 77380

United States, Virginia

Virginia Oncology Associates ( Site 0163)

Newport News, Virginia, United States, 23606

Virginia Oncology Associates ( Site 0153)

Norfolk, Virginia, United States, 23502

Virginia Oncology Associates ( Site 0164)

Virginia Beach, Virginia, United States, 23456

United States, Washington

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

Yakima, Washington, United States, 98902

Canada, Ontario

Princess Margaret Cancer Centre ( Site 0005)

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

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

Laval, Quebec, Canada, H7M 3L9

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

Montreal, Quebec, Canada, H2X 3E4

Jewish General Hospital ( Site 0010)

Montreal, Quebec, Canada, H3T 1E2

McGill University Health Centre ( Site 0002)

Montreal, Quebec, Canada, H4A 3J1

Chile

Centro Investigación del Cáncer James Lind ( Site 0510)

Temuco, Araucania, Chile, 4780000

IC La Serena Research ( Site 0511)

La Serena, Coquimbo, Chile, 1720430

Fundacion Arturo Lopez Perez ( Site 0500)

Santiago, Region M. De Santiago, Chile, 7500921

Pontificia Universidad Catolica de Chile ( Site 0501)

Santiago, Region M. De Santiago, Chile, 8330032

Oncocentro ( Site 0502)

Vina del Mar, Valparaiso, Chile, 2520598

Colombia

Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601)

Medellin, Antioquia, Colombia, 050030

Clinica de la Costa Ltda. ( Site 0600)

Barranquilla, Atlantico, Colombia, 080020

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

Barranquilla, Atlantico, Colombia, 080020

Oncomedica S.A. ( Site 0606)

Monteria, Cordoba, Colombia, 230002

Fundacion Valle del Lili ( Site 0602)

Cali, Valle Del Cauca, Colombia, 760032

Hemato Oncologos S.A. ( Site 0603)

Cali, Valle Del Cauca, Colombia, 760042

France

Centre Francois Baclesse ( Site 1012)

Caen, Calvados, France, 14076

CHU-Jean Minjoz ( Site 1013)

Besancon, Doubs, France, 25030

Institut Claudius Regaud IUCT Oncopole ( Site 1001)

Toulouse, Haute-Garonne, France, 31059

Centre de Cancerologie du Grand Montpellier ( Site 1009)

Montpellier, Languedoc-Roussillon, France, 34070

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

Metz, Moselle, France, 57085

Centre Jean Perrin ( Site 1003)

Clermont-Ferrand Cedex 01, Puy-de-Dome, France, 63001

Centre Leon Berard ( Site 1018)

Lyon, Rhone, France, 69373

Centre Henri Becquerel ( Site 1020)

Rouen, Seine-Maritime, France, 76038

CHU Amiens Hopital Sud ( Site 1023)

Amiens, Somme, France, 80000

Institut Gustave Roussy ( Site 1010)

Villejuif, Val-de-Marne, France, 94805

Institut Sainte Catherine ( Site 1026)

Avignon, Vaucluse, France, 84918

Hôpital Saint-Louis ( Site 1025)

Paris, France, 75010

Germany

Universitaetsklinikum Mannheim GmbH ( Site 1213)

Mannheim, Baden-Wurttemberg, Germany, 68167

Universitaetsklinikum Erlangen ( Site 1201)

Erlangen, Bayern, Germany, 91054

Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe ( Site 1200)

Muenchen, Bayern, Germany, 80337

Hochwaldkrankenhaus Bad Nauheim ( Site 1211)

Bad Nauheim, Hessen, Germany, 61231

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

Offenbach am Main, Hessen, Germany, 63069

Gynaekologisch-onkologische Praxis Hannover ( Site 1207)

Hannover, Niedersachsen, Germany, 30177

Gynaekologisches Zentrum-Schwerpunkt Gyn. Onkologie ( Site 1205)

Bonn, Nordrhein-Westfalen, Germany, 53111

Universitaetsklinikum AoeR Duesseldorf ( Site 1210)

Duesseldorf, Nordrhein-Westfalen, Germany, 40225

Kliniken Essen-Mitte ( Site 1215)

Essen, Nordrhein-Westfalen, Germany, 45136

Frauenklinik St. Louise ( Site 1216)

Paderborn, Nordrhein-Westfalen, Germany, 33098

Universitaetsklinikum Carl Gustav Carus ( Site 1203)

Dresden, Sachsen, Germany, 01307

Hungary

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

Kecskemét, Bacs-Kiskun, Hungary, 6000

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 1607)

Pecs, Baranya, Hungary, 7624

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

Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000

Zala Megyei Szent Rafael Korhaz ( Site 1605)

Zalaegerszeg, Zala, Hungary, 8900

Orszagos Onkologiai Intezet ( Site 1602)

Budapest, Hungary, 1122

Debreceni Egyetem Klinikai Kozpont ( Site 1600)

Debrecen, Hungary, 4032

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1604)

Kaposvar, Hungary, 7400

Ireland

Cork University Hospital ( Site 0902)

Cork, Ireland, T12 DC4A

St Vincents University Hospital ( Site 0900)

Dublin, Ireland, D04 YN63

Japan

Aichi Cancer Center Hospital ( Site 2202)

Nagoya, Aichi, Japan, 464-8681

Hyogo College of Medicine Hospital ( Site 2203)

Nishinomiya, Hyogo, Japan, 663-8501

Fukushima Medical University Hospital ( Site 2201)

Fukushima, Japan, 960-1295

Hiroshima City Hiroshima Citizens Hospital ( Site 2204)

Hiroshima, Japan, 730-8518

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 22

Osaka, Japan, 540-0006

Korea, Republic of

National Cancer Center ( Site 2406)

Goyang-si, Kyonggi-do, Korea, Republic of, 10408

Seoul National University Bundang Hospital ( Site 2409)

Seongnam-si, Kyonggi-do, Korea, Republic of, 13605

Ajou University Hospital ( Site 2407)

Suwon-si, Kyonggi-do, Korea, Republic of, 16499

Kyungpook National University Chilgok Hospital ( Site 2402)

Daegu, Taegu-Kwangyokshi, Korea, Republic of, 41404

Gachon University Gil Medical Center ( Site 2408)

Incheon, Korea, Republic of, 21565

Seoul National University Hospital ( Site 2403)

Seoul, Korea, Republic of, 03080

Severance Hospital Yonsei University Health System ( Site 2401)

Seoul, Korea, Republic of, 03722

Asan Medical Center ( Site 2404)

Seoul, Korea, Republic of, 05505

Samsung Medical Center ( Site 2405)

Seoul, Korea, Republic of, 06351

Poland

Regionalny Szpital Specjalistyczny Latawiec ( Site 1917)

Swidnica, Dolnoslaskie, Poland, 58-100

Pratia MCM Krakow ( Site 1919)

Krakow, Malopolskie, Poland, 30-510

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

Warszawa, Mazowieckie, Poland, 02-781

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

Gdynia, Pomorskie, Poland, 81-519

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1912)

Gliwice, Slaskie, Poland, 44-102

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

Pleszew, Wielkopolskie, Poland, 65-300

Spain

Hospital Universitario Reina Sofia ( Site 0705)

Cordoba, Andalucia, Spain, 14004

Hospital General Arnau de Vilanova de Valencia ( Site 0706)

Valencia, Valenciana, Comunitat, Spain, 46015

Instituto Oncologico Baselga.Hospital Quiron. ( Site 0707)

Barcelona, Spain, 08023

Hospital Universitari Vall d Hebron ( Site 0701)

Barcelona, Spain, 08035

Hospital Clinic I Provincial de Barcelona ( Site 0702)

Barcelona, Spain, 08036

Clinica Universitaria Navarra - Madrid ( Site 0700)

Madrid, Spain, 28027

Taiwan

Kaohsiung Chang Gung Memorial Hospital ( Site 2304)

Kaohsiung, Taiwan, 83301

National Cheng Kung University Hospital ( Site 2303)

Tainan, Taiwan, 704

MacKay Memorial Hospital ( Site 2301)

Taipei, Taiwan, 10449

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

Taipei, Taiwan, 112

China Medical University Hospital ( Site 2302)

Taipei, Taiwan, 40447

Ukraine

Chernihiv Medical Center of Modern Oncology ( Site 1520)

Chernihiv, Chernihivska Oblast, Ukraine, 14029

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

Dnipro, Dnipropetrovska Oblast, Ukraine, 49102

CI Krivorizhskiy oncology dispensery ( Site 1504)

Kryviy Rih, Dnipropetrovska Oblast, Ukraine, 50048

MI Precarpathian Clinical Oncology Center ( Site 1506)

Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018

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

Kharkiv, Kharkivska Oblast, Ukraine, 61024

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

Kharkiv, Kharkivska Oblast, Ukraine, 61070

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

Kharkiv, Kharkivska Oblast, Ukraine, 61103

Medical Centre Consilium Medical ( Site 1514)

Kyiv, Kyivska Oblast, Ukraine, 04050

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

Zaporizhzhia, Zaporizka Oblast, Ukraine, 69035

Medical Centre LLC Oncolife ( Site 1510)

Zaporizhzhya, Zaporizka Oblast, Ukraine, 69104

Zhytomyr Regional Oncology Center ( Site 1515)

Zhytomyr, Zhytomyrska Oblast, Ukraine, 10002

Medical Center Verum ( Site 1501)

Kyiv, Ukraine, 03039

United Kingdom

Raigmore Hospital ( Site 0915)

Inverness, Highland, United Kingdom, IV2 3UJ

Blackpool Victoria Hospital ( Site 0921)

Blackpool, Lancashire, United Kingdom, FY3 8NR

North West Cancer Centre ( Site 0922)

Londonderry, London, City Of, United Kingdom, BT47 6SB

Barts Health NHS Trust ( Site 0912)

London, London, City Of, United Kingdom, EC1M 6BQ

Musgrove Park Hospital ( Site 0918)

Taunton, Somerset, United Kingdom, TA1 5DA

The Christie NHS Foundation Trust ( Site 0914)

Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

More Information

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT04191135
• Other Study ID Numbers: 7339-009; MK-7339-009 ( Other Identifier: Merck ); KEYLYNK-009 ( Other Identifier: Merck ); 195082 ( Registry Identifier: JAPIC-CTI ); 2022-500418-24-00 ( Registry Identifier: EU CT ); 2019-001892-35 ( EudraCT Number )
• First Posted: December 9, 2019
• Last Update Posted: October 12, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme LLC:

Programmed Cell Death Receptor 1 (PD-1, PD1); Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1); Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2)

Additional relevant MeSH terms:

Triple Negative Breast Neoplasms; Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Carboplatin; Gemcitabine; Pembrolizumab; Olaparib; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors; Enzyme Inhibitors