Clinical trial NCT04191135: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Triple Negative Breast Neoplasms
Keywords: 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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-12-09
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.


Eligibility 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 29 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 29 months
Secondary outcomes:
measure: Progression-Free Survival (PFS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors With a Combined Positive Score (CPS) ≥10
timeFrame: Up to approximately 29 months
measure: Overall Survival (OS) in Participants With PD-L1 Positive Tumors With a CPS ≥10
timeFrame: Up to approximately 29 months
measure: PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors
timeFrame: Up to approximately 29 months
measure: OS in Participants With BRCAm Tumors
timeFrame: Up to approximately 29 months
measure: 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 Combined Score
timeFrame: Baseline and week 18
measure: 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
timeFrame: Baseline and week 18
measure: 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
timeFrame: Baseline and week 18
measure: Change From Baseline in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific QoL Questionnaire (EORTC QLQ-BR23) Items 1-4, 6, 7, and 8 Score
timeFrame: Baseline and week 18
measure: Change From Baseline in Visual Analogue Scale (VAS) Score on the European Quality of Life 5-dimension, 5-level Questionnaire (EQ-5D-5L)
timeFrame: Baseline and week 18
measure: Change From Baseline in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors
timeFrame: Baseline and up to 18 weeks
measure: Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score in Participants With BRCAm Tumors
timeFrame: Baseline and week 18
measure: Change From Baseline in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score in Participants With BRCAm Tumors
timeFrame: Baseline and week 18
measure: Change From Baseline in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score in Participants With BRCAm Tumors
timeFrame: Baseline and week 18
measure: Change From Baseline in Visual Analogue Scale (VAS) Score on the EQ-5D-5L in Participants With BRCAm Tumors
timeFrame: Baseline and week 18
measure: Time to Deterioration (TTD) in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Score
timeFrame: Baseline and up to approximately 29 months
measure: TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
timeFrame: Up to approximately 29 months
measure: TTD in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score
timeFrame: Up to approximately 29 months
measure: TTD in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score
timeFrame: Up to approximately 29 months
measure: TTD in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Score in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors
timeFrame: Baseline and up to approximately 29 months
measure: TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score in Participants With BRCAm Tumors
timeFrame: Up to approximately 29 months
measure: TTD in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score in Participants With BRCAm Tumors
timeFrame: Up to approximately 29 months
measure: TTD in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score in Participants With BRCAm Tumors
timeFrame: Up to approximately 29 months
measure: Number of Participants Who Experienced At Least One Adverse Event (AE)
timeFrame: Up to approximately 29 months
measure: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 29 months
Other outcomes:
Locations:
city: Monterey
country: United States
facility: Pacific Cancer Care ( Site 0142)
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute ( Site 0111)
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare ( Site 0104)
state: California
city: Miami
country: United States
facility: University of Miami Sylvester CC ( Site 0146)
state: Florida
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University ( Site 0129)
state: Georgia
city: Chicago
country: United States
facility: University of Chicago ( Site 0159)
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 0155)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 0103)
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute ( Site 0157)
state: Minnesota
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161)
state: New Jersey
city: Montvale
country: United States
facility: MSKCC-Bergen ( Site 0162)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160)
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center ( Site 0156)
state: New York
city: Oklahoma City
country: United States
facility: Mercy Clinic Oncology and Hematology ( Site 0110)
state: Oklahoma
city: Fort Worth
country: United States
facility: The Center For Cancer And Blood Disorders ( Site 0151)
state: Texas
city: New Braunfels
country: United States
facility: Texas Oncology-New Braunfels ( Site 0168)
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio Northeast ( Site 0165)
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio Medical Center ( Site 0158)
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Stone Oak ( Site 0166)
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical ( Site 0117)
state: Texas
city: Newport News
country: United States
facility: Virginia Oncology Associates ( Site 0163)
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates ( Site 0153)
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates ( Site 0164)
state: Virginia
city: Yakima
country: United States
facility: YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128)
state: Washington
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0005)
state: Ontario
city: Laval
country: Canada
facility: CSSS de Laval- Hopital de la Cite de la Sante ( Site 0011)
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0003)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0010)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0002)
state: Quebec
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0510)
state: Araucania
city: La Serena
country: Chile
facility: IC La Serena Research ( Site 0511)
state: Coquimbo
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez ( Site 0500)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0501)
state: Region M. De Santiago
city: Vina del Mar
country: Chile
facility: Oncocentro ( Site 0502)
state: Valparaiso
city: Medellin
country: Colombia
facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda. ( Site 0600)
state: Atlantico
city: Barranquilla
country: Colombia
facility: Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0609)
state: Atlantico
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0606)
state: Cordoba
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 0602)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Hemato Oncologos S.A. ( Site 0603)
state: Valle Del Cauca
city: Caen
country: France
facility: Centre Francois Baclesse ( Site 1012)
state: Calvados
city: Besancon
country: France
facility: CHU-Jean Minjoz ( Site 1013)
state: Doubs
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 1001)
state: Haute-Garonne
city: Montpellier
country: France
facility: Centre de Cancerologie du Grand Montpellier ( Site 1009)
state: Languedoc-Roussillon
city: Metz
country: France
facility: CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 1007)
state: Moselle
city: Clermont-Ferrand Cedex 01
country: France
facility: Centre Jean Perrin ( Site 1003)
state: Puy-de-Dome
city: Lyon
country: France
facility: Centre Leon Berard ( Site 1018)
state: Rhone
city: Rouen
country: France
facility: Centre Henri Becquerel ( Site 1020)
state: Seine-Maritime
city: Amiens
country: France
facility: CHU Amiens Hopital Sud ( Site 1023)
state: Somme
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 1010)
state: Val-de-Marne
city: Avignon
country: France
facility: Institut Sainte Catherine ( Site 1026)
state: Vaucluse
city: Paris
country: France
facility: Hôpital Saint-Louis ( Site 1025)
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim GmbH ( Site 1213)
state: Baden-Wurttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen ( Site 1201)
state: Bayern
city: Muenchen
country: Germany
facility: Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe ( Site 1200)
state: Bayern
city: Bad Nauheim
country: Germany
facility: Hochwaldkrankenhaus Bad Nauheim ( Site 1211)
state: Hessen
city: Offenbach am Main
country: Germany
facility: Sana Klinikum Offenbach Klinik fuer Gynakologie und Geburtshilfe ( Site 1206)
state: Hessen
city: Hannover
country: Germany
facility: Gynaekologisch-onkologische Praxis Hannover ( Site 1207)
state: Niedersachsen
city: Bonn
country: Germany
facility: Gynaekologisches Zentrum-Schwerpunkt Gyn. Onkologie ( Site 1205)
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum AoeR Duesseldorf ( Site 1210)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte ( Site 1215)
state: Nordrhein-Westfalen
city: Paderborn
country: Germany
facility: Frauenklinik St. Louise ( Site 1216)
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus ( Site 1203)
state: Sachsen
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1608)
state: Bacs-Kiskun
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 1607)
state: Baranya
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1601)
state: Jasz-Nagykun-Szolnok
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz ( Site 1605)
state: Zala
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 1602)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 1600)
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1604)
city: Cork
country: Ireland
facility: Cork University Hospital ( Site 0902)
city: Dublin
country: Ireland
facility: St Vincents University Hospital ( Site 0900)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 2202)
state: Aichi
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital ( Site 2203)
state: Hyogo
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 2201)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2204)
city: Osaka
country: Japan
facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research (Site 2200)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 2406)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 2409)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital ( Site 2407)
state: Kyonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital ( Site 2402)
state: Taegu-Kwangyokshi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center ( Site 2408)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2403)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 2401)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 2404)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2405)
city: Swidnica
country: Poland
facility: Regionalny Szpital Specjalistyczny Latawiec ( Site 1917)
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Pratia MCM Krakow ( Site 1919)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (Site 1908)
state: Mazowieckie
city: Gdynia
country: Poland
facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1913)
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1912)
state: Slaskie
city: Pleszew
country: Poland
facility: Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 1909)
state: Wielkopolskie
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia ( Site 0705)
state: Andalucia
city: Valencia
country: Spain
facility: Hospital General Arnau de Vilanova de Valencia ( Site 0706)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Instituto Oncologico Baselga.Hospital Quiron. ( Site 0707)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 0701)
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona ( Site 0702)
city: Madrid
country: Spain
facility: Clinica Universitaria Navarra - Madrid ( Site 0700)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital ( Site 2304)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2303)
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital ( Site 2301)
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2300)
city: Taipei
country: Taiwan
facility: China Medical University Hospital ( Site 2302)
city: Chernihiv
country: Ukraine
facility: Chernihiv Medical Center of Modern Oncology ( Site 1520)
state: Chernihivska Oblast
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 1502)
state: Dnipropetrovska Oblast
city: Kryviy Rih
country: Ukraine
facility: CI Krivorizhskiy oncology dispensery ( Site 1504)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 1506)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1508)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1512)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: SI-Zaytsev institute of general and urgent surgery-NAMS ( Site 1518)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: Medical Centre Consilium Medical ( Site 1514)
state: Kyivska Oblast
city: Zaporizhzhia
country: Ukraine
facility: Medical center of the Limited Liability Company Yulis ( Site 1517)
state: Zaporizka Oblast
city: Zaporizhzhya
country: Ukraine
facility: Medical Centre LLC Oncolife ( Site 1510)
state: Zaporizka Oblast
city: Zhytomyr
country: Ukraine
facility: Zhytomyr Regional Oncology Center ( Site 1515)
state: Zhytomyrska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center Verum ( Site 1501)
city: Inverness
country: United Kingdom
facility: Raigmore Hospital ( Site 0915)
state: Highland
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital ( Site 0921)
state: Lancashire
city: Londonderry
country: United Kingdom
facility: North West Cancer Centre ( Site 0922)
state: London, City Of
city: London
country: United Kingdom
facility: Barts Health NHS Trust ( Site 0912)
state: London, City Of
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital ( Site 0918)
state: Somerset
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 0914)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: