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)
NCT ID: NCT04191135
Last Updated: 2025-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
462 participants
INTERVENTIONAL
2019-12-19
2025-11-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab + Olaparib
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.
Pembrolizumab
intravenous (IV) infusion
Olaparib
oral tablets
Pembrolizumab + Carboplatin + Gemcitabine
This arm includes participants who randomized following completion of the induction period. Participants continued 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.
Pembrolizumab
intravenous (IV) infusion
Carboplatin
IV infusion
Gemcitabine
IV infusion
Interventions
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Pembrolizumab
intravenous (IV) infusion
Olaparib
oral tablets
Carboplatin
IV infusion
Gemcitabine
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
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
Centro Investigación del Cáncer James Lind ( Site 0510)
Temuco, Región de la Araucanía, Chile
Oncocentro ( Site 0502)
Viña del Mar, Región de Valparaíso, 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, Kharkivs’ka Oblast’, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1512)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
SI-Zaytsev institute of general and urgent surgery-NAMS ( Site 1518)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Medical Centre Consilium Medical ( Site 1514)
Kyiv, Kyivska Oblast, Ukraine
Medical center of the Limited Liability Company Yulis ( Site 1517)
Zaporizhzhia, 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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-7339-009
Identifier Type: OTHER
Identifier Source: secondary_id
KEYLYNK-009
Identifier Type: OTHER
Identifier Source: secondary_id
195082
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-500418-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1275-8575
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-001892-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7339-009
Identifier Type: -
Identifier Source: org_study_id
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