Clinical trial NCT03302234: Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
Official title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Programmed Cell Death Receptor 1 (PD-1)
Programmed Cell Death Receptor Ligand 1 (PD-L1)
Cytotoxic T-lymphocyte-associated protein 4 (CTLA4)
PD1
PD-1
PDL1
PD-L1
CTLA4
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-10-05
Enrollment: 568
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 determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.

With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.


Eligibility criteria: Inclusion Criteria:

* Has a histologically or cytologically confirmed diagnosis of Stage IV metastatic non-small cell lung cancer (NSCLC) (American Joint Committee on Cancer version 8)
* Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by investigator
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has a life expectancy of at least 3 months
* Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
* Female participants of reproductive potential must agree to use contraception starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication

Exclusion Criteria:

* Has received prior systemic chemotherapy/other targeted or biological antineoplastic therapy treatment for their Stage IV metastatic NSCLC
* Has a tumor that harbors an epidermal growth factor receptor (EGFR)-sensitizing (activating) mutation or an anaplastic lymphoma kinase (ALK) translocation
* Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy
* Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-Programmed Cell Death Receptor Ligand 1 (anti-PD-L1), or anti- Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
* Has received prior radiotherapy within 2 weeks of start of study therapy or received lung radiation therapy of \>30 Gray (Gy) within 6 months of the first dose of study therapy
* Has recovered from all radiation-related toxicities, does not require corticosteroids, and has not had radiation pneumonitis
* Is receiving systemic steroid therapy ≤7 days prior to the first dose of study therapy or receiving any other form of immunosuppressive medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers
* Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (i.e., doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy
* Has a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
* Has had an allogeneic tissue/solid organ transplant
* Has received a live vaccine within 30 days prior to the first dose of study therapy
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of hepatitis B or known active hepatitis C virus infection
* Has a known history of active tuberculosis
* Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial
* Is a regular user of any illicit drugs or had a recent history of substance abuse
* Is pregnant or breast feeding or expecting to conceive starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication
* Has severe hypersensitivity to pembrolizumab and/or any of its excipients and/or to ipilimumab and/or any of its excipients
* Has a c-ros oncogene 1 (ROS1) mutation

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 32 months (through data cut-off date: 01 Sep 2020)
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 32 months (through data cut-off date 01 Sep 2020)
Secondary outcomes:
measure: Objective Response Rate (ORR) Per RECIST 1.1 Based on BICR
timeFrame: Up to approximately 32 months (data cut-off date 01 Sep 2020)
measure: Duration of Response (DOR) Per RECIST 1.1 Based on BICR
timeFrame: Up to approximately 32 months (data cut-off date 01 Sep 2020)
measure: Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath
timeFrame: Up to approximately 32 months (data cut-off date 01 Sep 2020)
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 27 months
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to approximately 24 months
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score to Week 18
timeFrame: Baseline, Week 18
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Cancer Center ( Site 0007)
state: Arizona
city: Burbank
country: United States
facility: Disney Family Cancer Center ( Site 0035)
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care ( Site 0001)
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute ( Site 0021)
state: California
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute ( Site 0009)
state: Florida
city: Paducah
country: United States
facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018)
state: Kentucky
city: Scarborough
country: United States
facility: New England Cancer Specialists ( Site 0019)
state: Maine
city: Boston
country: United States
facility: Boston Medical Center ( Site 0025)
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center ( Site 0020)
state: Massachusetts
city: Teaneck
country: United States
facility: Holy Name Medical Center ( Site 0022)
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 0034)
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center ( Site 0016)
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology/Hematology Inc. ( Site 0003)
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031)
state: Oregon
city: Greenville
country: United States
facility: Greenville Health System ( Site 8010)
state: South Carolina
city: Chattanooga
country: United States
facility: University of Tennessee Erlanger Oncology & Hematology ( Site 0026)
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists ( Site 0017)
state: Tennessee
city: Arlington
country: United States
facility: Texas Oncology-Arlington South ( Site 8006)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Methodist Dallas Cancer Center ( Site 8000)
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology-Flower Mound ( Site 8007)
state: Texas
city: Longview
country: United States
facility: Texas Oncology-Longview Cancer Center ( Site 8009)
state: Texas
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C. ( Site 8001)
state: Washington
city: Yakima
country: United States
facility: Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033)
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center ( Site 0004)
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Clinical Cancer Center ( Site 0027)
state: Wisconsin
city: Viedma
country: Argentina
facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202)
state: Rio Negro
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0201)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 0208)
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico Cordoba ( Site 0206)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 0203)
city: Rosario
country: Argentina
facility: Sanatorio Britanico ( Site 0205)
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario ( Site 0200)
city: Tucuman
country: Argentina
facility: Centro Medico San Roque ( Site 0207)
city: South Brisbane
country: Australia
facility: Mater Cancer Care Centre ( Site 2102)
state: Queensland
city: Perth
country: Australia
facility: Fiona Stanley Hospital ( Site 2105)
state: Western Australia
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse ( Site 2100)
city: Douglas
country: Australia
facility: The Townsville Hospital ( Site 2103)
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne ( Site 2101)
city: Recife
country: Brazil
facility: Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0302)
state: Pernambuco
city: Santa Maria
country: Brazil
facility: Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao ( Site 0306)
state: RS
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0300)
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz ( Site 0311)
state: SP
city: Sao Paulo
country: Brazil
facility: Escola Paulista de Medicina - UNIFESP ( Site 0304)
state: SP
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312)
city: Florianopolis
country: Brazil
facility: CEPON Centro de Pesquisa Oncológicas ( Site 0307)
city: Sao Paulo
country: Brazil
facility: Hospital do Servidor Publico do Estado ( Site 0308)
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre ( Site 0119)
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 0106)
state: Manitoba
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0115)
state: Quebec
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre ( Site 0100)
state: Quebec
city: Levis
country: Canada
facility: CISSS-CA Hotel-Dieu de Levis ( Site 0108)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107)
state: Quebec
city: St-Jerome
country: Canada
facility: St-Jerome Medical Research Inc ( Site 0113)
state: Quebec
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule ( Site 0413)
state: El Maule
city: Santiago
country: Chile
facility: Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401)
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0404)
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer ( Site 0406)
city: Vina del Mar
country: Chile
facility: Hospital Clinico Vina del Mar ( Site 0400)
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe ( Site 0505)
state: Antioquia
city: Bogota
country: Colombia
facility: Centro de Investigacion Clinica del Country ( Site 0500)
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506)
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0502)
city: Pasto
country: Colombia
facility: Instituto Cancerologico de Narino Ltda ( Site 0504)
city: Marseille
country: France
facility: Hopital Nord du Marseille ( Site 0808)
state: Cedex 20
city: Bordeaux
country: France
facility: Institut Bergonie ( Site 0803)
city: Brest
country: France
facility: CHU de Brest. Hopital Morvan ( Site 0800)
city: Creteil
country: France
facility: Centre Hopitalier Intercommunal Creteil ( Site 0802)
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans ( Site 0804)
city: Lille
country: France
facility: C.H.R.U de Lille - Hopital Calmette ( Site 0805)
city: Paris
country: France
facility: Hopital Tenon ( Site 0810)
city: Strasbourg
country: France
facility: Nouvel Hopital Civil ( Site 0809)
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Larrey ( Site 0801)
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin ( Site 0903)
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau ( Site 0910)
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring ( Site 0905)
city: Gera
country: Germany
facility: SRH Waldklinikum Gera GmbH ( Site 0907)
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf GmbH ( Site 0908)
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg ( Site 0900)
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig ( Site 0919)
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig Holstein. ( Site 0918)
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502)
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506)
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 1509)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 1511)
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet ( Site 1503)
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 1505)
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501)
city: Dublin
country: Ireland
facility: Beaumont Hospital ( Site 1312)
city: Dublin
country: Ireland
facility: St James Hospital ( Site 1401)
city: Limerick
country: Ireland
facility: University Hospital Limerick ( Site 1403)
city: San Giovanni Rotondo (FG)
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza ( Site 1009)
state: Foggia
city: Rozzano
country: Italy
facility: Humanitas Research Hospital ( Site 1004)
state: Milano
city: Legnago
country: Italy
facility: Ospedale Mater Salutis ( Site 1005)
state: Verona
city: Brescia
country: Italy
facility: ASST Spedali Civili ( Site 1001)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia ( Site 1007)
city: Monza
country: Italy
facility: Ospedale San Gerardo ASST Monza ( Site 1002)
city: Napoli
country: Italy
facility: AORN dei Colli Plesso Monaldi ( Site 1003)
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia ( Site 1008)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2303)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 2300)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 2302)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2301)
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital ( Site 1100)
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital ( Site 1111)
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603)
state: Jalisco
city: Monterrey
country: Mexico
facility: Avix Investigacion Clinica S.C. ( Site 0600)
state: N.l.
city: Merida
country: Mexico
facility: Medical Care and Research S.A. de C.V. ( Site 0602)
state: Yucatan
city: Ciudad de Mexico
country: Mexico
facility: Grupo Medico Camino SC ( Site 0607)
city: Mexico City
country: Mexico
facility: Medica Sur S.A.B de C.V. ( Site 0608)
city: Puebla
country: Mexico
facility: Oncologica de Puebla SA de CV ( Site 0606)
city: La Victoria
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)
state: Lima
city: Arequipa
country: Peru
facility: Centro Especializado de Enfermedades Neoplasicas SRL-CEEN SRL ( Site 0710)
city: Arequipa
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 0704)
city: Lima
country: Peru
facility: Clinica Internacional Sede San Borja ( Site 0701)
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia ( Site 0706)
city: Trujillo
country: Peru
facility: Clinica Peruano Americana S.A. ( Site 0703)
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii. ( Site 1616)
state: Dolnoslaskie
city: Koszalin
country: Poland
facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614)
state: Zachodniopomorskie
city: Brzeziny
country: Poland
facility: Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609)
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed ( Site 1602)
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)
city: Poznan
country: Poland
facility: MED-POLONIA Sp. z o.o. ( Site 1605)
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600)
city: Bloemfontein
country: South Africa
facility: Universitas Annex National Hospital ( Site 1800)
state: Free State
city: Alberton
country: South Africa
facility: Clinton Onclogy Clinic ( Site 1804)
state: Gauteng
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre ( Site 1808)
state: Gauteng
city: Cape Town
country: South Africa
facility: Vincent Pallotti Hospital ( Site 1811)
city: Cape Town
country: South Africa
facility: University of Stellenbosch and Tygerberg Hospital ( Site 1810)
city: Durban
country: South Africa
facility: Dr G.A. Landers Specialist Oncologist ( Site 1803)
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806)
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group PTY LTD ( Site 1807)
city: Kraaifontein
country: South Africa
facility: GVI Oncology Clinical Research Centre ( Site 1802)
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol ( Site 1207)
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals ( Site 1201)
state: Barcelona
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara ( Site 1208)
state: Extremadura
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria ( Site 1203)
state: Gran Canaria
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 1211)
city: Madrid
country: Spain
facility: Hospital Fundacion Jimenez Diaz - Clin. Concepcion ( Site 1209)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio ( Site 1200)
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital ( Site 2406)
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation - Kaohsiung ( Site 2404)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 2403)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2401)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 2400)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 2405)
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 2402)
city: Ratchthevee
country: Thailand
facility: Ramathibodi Hospital. ( Site 2563)
state: Bangkok
city: Mueang
country: Thailand
facility: Bangkok Hospital Chiangmai ( Site 2560)
state: Chiang Mai
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital ( Site 2561)
city: Bangkok
country: Thailand
facility: Pramongkutklao Hospital ( Site 2564)
city: Bangkok
country: Thailand
facility: Siriraj Hospital ( Site 2562)
city: Khon Kaen
country: Thailand
facility: Khon Kaen University ( Site 2565)
city: Adana
country: Turkey
facility: Acibadem Adana Hastanesi ( Site 1904)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)
city: Bursa
country: Turkey
facility: Uludag Universitesi Tip Fakultesi ( Site 1914)
city: Cankaya - Ankara
country: Turkey
facility: Ankara Sehir Hastanesi ( Site 1903)
city: Edirne
country: Turkey
facility: Trakya Uni. Tip Fakultesi ( Site 1911)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)
city: Izmir
country: Turkey
facility: Medical Park Izmir Hospital ( Site 1900)
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi ( Site 1909)
city: Malatya
country: Turkey
facility: Inonu Universitesi Tip Fakultesi ( Site 1907)
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Universitesi ( Site 1910)
city: Kryviy Rih
country: Ukraine
facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005)
state: Dnipropetrovsk Region
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Hospital ( Site 2020)
city: Chernivtsy
country: Ukraine
facility: Regional Clinical Onco Dispensary_ State Medical University ( Site 2012)
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC ( Site 2000)
city: Ivano-Frankivsk
country: Ukraine
facility: MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009)
city: Kropyvnytskyi
country: Ukraine
facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2002)
city: Kyiv
country: Ukraine
facility: National Cancer Institute of the MoH of Ukraine ( Site 2015)
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncological Center ( Site 2014)
city: Lviv
country: Ukraine
facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2003)
city: Odesa
country: Ukraine
facility: MI Odessa Regional Oncological Centre ( Site 2004)
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital ( Site 1325)
state: Cornwall
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust. ( Site 1326)
state: Surrey
city: Belfast
country: United Kingdom
facility: Belfast City Hospital ( Site 1302)
city: London
country: United Kingdom
facility: Royal Free NHS Foundation Trust ( Site 1324)
city: London
country: United Kingdom
facility: St. Georges University Hospital NHS Foundation Trust ( Site 1321)
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust.. ( Site 1327)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 1301)
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 1307)
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton Hospitals NHS Trust ( Site 1323)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Boyer M, Sendur MAN, Rodriguez-Abreu D, Park K, Lee DH, Cicin I, Yumuk PF, Orlandi FJ, Leal TA, Molinier O, Soparattanapaisarn N, Langleben A, Califano R, Medgyasszay B, Hsia TC, Otterson GA, Xu L, Piperdi B, Samkari A, Reck M; KEYNOTE-598 Investigators. Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score >/= 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study. J Clin Oncol. 2021 Jul 20;39(21):2327-2338. doi: 10.1200/JCO.20.03579. Epub 2021 Jan 29.