Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
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)
4 other identifiers
interventional
568
24 countries
187
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2017
Longer than P75 for phase_3
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2017
CompletedFirst Posted
Study publicly available on registry
October 5, 2017
CompletedStudy Start
First participant enrolled
December 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedResults Posted
Study results publicly available
September 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2022
CompletedSeptember 26, 2023
September 1, 2023
2.7 years
September 26, 2017
August 12, 2021
September 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. The median survival (in months) and the associated 95% confidence intervals (CIs) were reported using Kaplan-Meier method was used. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and predominant tumor history (squamous versus non-squamous) was used to estimate hazard ratio (HR) and 95% CIs for first course study treatment per protocol.
Up to approximately 32 months (through data cut-off date: 01 Sep 2020)
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)
PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in sum of diameters of target lesions. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The median survival (in months) and associated 95% CIs were reported using Kaplan-Meier method. Cox regression model with Efron's method of tie handling with treatment as covariate stratified by ECOG performance status (0 vs. 1), geographic region of the enrolling site (East Asia vs. non-East Asia), and predominant tumor history (squamous vs. non-squamous) was used to estimate HR and 95% CIs for first course study treatment per protocol.
Up to approximately 32 months (through data cut-off date 01 Sep 2020)
Secondary Outcomes (6)
Objective Response Rate (ORR) Per RECIST 1.1 Based on BICR
Up to approximately 32 months (data cut-off date 01 Sep 2020)
Duration of Response (DOR) Per RECIST 1.1 Based on BICR
Up to approximately 32 months (data cut-off date 01 Sep 2020)
Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath
Up to approximately 32 months (data cut-off date 01 Sep 2020)
Number of Participants Who Experienced an Adverse Event (AE)
Up to approximately 27 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Up to approximately 24 months
- +1 more secondary outcomes
Study Arms (2)
Pembrolizumab + Ipilimumab
EXPERIMENTALParticipants receive 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.
Pembrolizumab + Placebo
ACTIVE COMPARATORParticipants receive 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.
Interventions
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Administered as an IV infusion every 6 weeks (Q6W)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (187)
Mayo Clinic Cancer Center ( Site 0007)
Phoenix, Arizona, 85054, United States
Disney Family Cancer Center ( Site 0035)
Burbank, California, 91505, United States
Pacific Cancer Care ( Site 0001)
Monterey, California, 93940, United States
John Wayne Cancer Institute ( Site 0021)
Santa Monica, California, 90404, United States
Florida Hospital Cancer Institute ( Site 0009)
Orlando, Florida, 32804, United States
Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018)
Paducah, Kentucky, 42003, United States
New England Cancer Specialists ( Site 0019)
Scarborough, Maine, 04074, United States
Boston Medical Center ( Site 0025)
Boston, Massachusetts, 02118, United States
Lahey Hospital & Medical Center ( Site 0020)
Burlington, Massachusetts, 01805, United States
Holy Name Medical Center ( Site 0022)
Teaneck, New Jersey, 07666, United States
Icahn School of Medicine at Mount Sinai ( Site 0034)
New York, New York, 10029, United States
The Ohio State University Wexner Medical Center ( Site 0016)
Columbus, Ohio, 43210, United States
Mid Ohio Oncology/Hematology Inc. ( Site 0003)
Columbus, Ohio, 43219, United States
Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031)
Portland, Oregon, 97213, United States
Greenville Health System ( Site 8010)
Greenville, South Carolina, 29615, United States
University of Tennessee Erlanger Oncology & Hematology ( Site 0026)
Chattanooga, Tennessee, 37403, United States
Tennessee Cancer Specialists ( Site 0017)
Knoxville, Tennessee, 37909, United States
Texas Oncology-Arlington South ( Site 8006)
Arlington, Texas, 76014, United States
Texas Oncology-Methodist Dallas Cancer Center ( Site 8000)
Dallas, Texas, 75203, United States
Texas Oncology-Flower Mound ( Site 8007)
Flower Mound, Texas, 75028, United States
Texas Oncology-Longview Cancer Center ( Site 8009)
Longview, Texas, 75601, United States
Northwest Cancer Specialists, P.C. ( Site 8001)
Vancouver, Washington, 98684, United States
Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033)
Yakima, Washington, 98902, United States
University of Wisconsin Carbone Cancer Center ( Site 0004)
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin Clinical Cancer Center ( Site 0027)
Milwaukee, Wisconsin, 53226, United States
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202)
Viedma, Río Negro Province, R8500ACE, Argentina
Sanatorio Parque ( Site 0201)
Rosario, Santa Fe Province, S2000DSV, Argentina
Hospital Aleman ( Site 0208)
Buenos Aires, C1118AAT, Argentina
Hospital Privado Centro Medico Cordoba ( Site 0206)
Córdoba, X5016KEH, Argentina
Centro Oncologico Riojano Integral ( Site 0203)
La Rioja, F5300COE, Argentina
Sanatorio Britanico ( Site 0205)
Rosario, S2000CVB, Argentina
Instituto de Oncologia de Rosario ( Site 0200)
Rosario, S2000KZE, Argentina
Centro Medico San Roque ( Site 0207)
San Miguel de Tucumán, T4000IAK, Argentina
Mater Cancer Care Centre ( Site 2102)
South Brisbane, Queensland, 4101, Australia
Fiona Stanley Hospital ( Site 2105)
Perth, Western Australia, 6150, Australia
Chris OBrien Lifehouse ( Site 2100)
Camperdown, 2050, Australia
The Townsville Hospital ( Site 2103)
Douglas, 4814, Australia
St Vincents Hospital Melbourne ( Site 2101)
Fitzroy, 3065, Australia
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0302)
Recife, Pernambuco, 50070-550, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0306)
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)
Santa Maria, Rio Grande do Sul, 97015-513, Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 0300)
São Paulo, São Paulo, 01246-000, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0311)
São Paulo, São Paulo, 01323-020, Brazil
Escola Paulista de Medicina - UNIFESP ( Site 0304)
São Paulo, São Paulo, 04024-002, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312)
Barretos, 14784-400, Brazil
CEPON Centro de Pesquisa Oncológicas ( Site 0307)
Florianópolis, 88034-000, Brazil
Hospital do Servidor Publico do Estado ( Site 0308)
São Paulo, 04039-004, Brazil
Tom Baker Cancer Centre ( Site 0119)
Calgary, Alberta, T2N 4N2, Canada
CancerCare Manitoba ( Site 0106)
Winnipeg, Manitoba, R3E 0V9, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0115)
Chicoutimi, Quebec, G7H 5H6, Canada
CISSS de la Monteregie-Centre ( Site 0100)
Greenfield Park, Quebec, J4V 2H1, Canada
CISSS-CA Hotel-Dieu de Levis ( Site 0108)
Lévis, Quebec, G6V 3Z1, Canada
CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107)
Montreal, Quebec, H3T 1M5, Canada
St-Jerome Medical Research Inc ( Site 0113)
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Clinica Universidad Catolica del Maule ( Site 0413)
Talca, El Maule, 3465584, Chile
Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401)
Santiago, 7500006, Chile
Pontificia Universidad Catolica de Chile ( Site 0404)
Santiago, 8330032, Chile
Instituto Nacional del Cancer ( Site 0406)
Santiago, 8380455, Chile
Hospital Clinico Vina del Mar ( Site 0400)
Viña del Mar, 2520000, Chile
Hospital Pablo Tobon Uribe ( Site 0505)
Medellín, Antioquia, 050034, Colombia
Centro de Investigacion Clinica del Country ( Site 0500)
Bogotá, 110221, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506)
Bogotá, 110311, Colombia
Oncomedica S.A. ( Site 0502)
Montería, 230002, Colombia
Instituto Cancerologico de Narino Ltda ( Site 0504)
Pasto, 520001, Colombia
Hopital Nord du Marseille ( Site 0808)
Marseille, Cedex 20, 13015, France
Institut Bergonie ( Site 0803)
Bordeaux, 33076, France
CHU de Brest. Hopital Morvan ( Site 0800)
Brest, 29200, France
Centre Hopitalier Intercommunal Creteil ( Site 0802)
Créteil, 94010, France
Centre Hospitalier Le Mans ( Site 0804)
Le Mans, 72037, France
C.H.R.U de Lille - Hopital Calmette ( Site 0805)
Lille, 59037, France
Hopital Tenon ( Site 0810)
Paris, 75020, France
Nouvel Hopital Civil ( Site 0809)
Strasbourg, 67091, France
CHU de Toulouse - Hopital Larrey ( Site 0801)
Toulouse, 31059, France
Evangelische Lungenklinik Berlin ( Site 0903)
Berlin, 13125, Germany
Vivantes Klinikum Spandau ( Site 0910)
Berlin, 13585, Germany
HELIOS Klinikum Emil von Behring ( Site 0905)
Berlin, 14165, Germany
SRH Waldklinikum Gera GmbH ( Site 0907)
Gera, 07548, Germany
LungenClinic Grosshansdorf GmbH ( Site 0908)
Großhansdorf, 22927, Germany
Universitaetsklinikum Heidelberg ( Site 0900)
Heidelberg, 69126, Germany
Universitaetsklinikum Leipzig ( Site 0919)
Leipzig, 04103, Germany
Universitaetsklinikum Schleswig Holstein. ( Site 0918)
Lübeck, 23538, Germany
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502)
Budapest, 1121, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506)
Budapest, 1122, Hungary
Orszagos Onkologiai Intezet ( Site 1509)
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1511)
Debrecen, 4032, Hungary
Veszprem Megyei Tudogyogyintezet ( Site 1503)
Farkasgyepű, 8582, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1505)
Győr, 9024, Hungary
Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)
Gyula, 5700, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)
Székesfehérvár, 8000, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501)
Szolnok, 5000, Hungary
Beaumont Hospital ( Site 1312)
Dublin, D09 V2N0, Ireland
St James Hospital ( Site 1401)
Dublin, Dublin 8, Ireland
University Hospital Limerick ( Site 1403)
Limerick, V94 F858, Ireland
IRCCS Casa Sollievo della Sofferenza ( Site 1009)
San Giovanni Rotondo (FG), Foggia, 71013, Italy
Humanitas Research Hospital ( Site 1004)
Rozzano, Milano, 20089, Italy
Ospedale Mater Salutis ( Site 1005)
Legnago, Verona, 37045, Italy
ASST Spedali Civili ( Site 1001)
Brescia, 25123, Italy
Istituto Europeo di Oncologia ( Site 1007)
Milan, 20141, Italy
Ospedale San Gerardo ASST Monza ( Site 1002)
Monza, 20900, Italy
AORN dei Colli Plesso Monaldi ( Site 1003)
Napoli, 80131, Italy
Ospedale Santa Maria della Misericordia ( Site 1008)
Perugia, 06132, Italy
Pauls Stradins Clinical University Hospital ( Site 1100)
Riga, 1002, Latvia
Riga East Clinical University Hospital ( Site 1111)
Riga, 1079, Latvia
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603)
Guadalajara, Jalisco, 44200, Mexico
Avix Investigacion Clinica S.C. ( Site 0600)
Monterrey, N.L., 64710, Mexico
Medical Care and Research S.A. de C.V. ( Site 0602)
Mérida, Yucatán, 97070, Mexico
Grupo Medico Camino SC ( Site 0607)
Mexico City, 03310, Mexico
Medica Sur S.A.B de C.V. ( Site 0608)
Mexico City, 14050, Mexico
Oncologica de Puebla SA de CV ( Site 0606)
Puebla City, 72530, Mexico
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)
La Victoria, Lima region, 15033, Peru
Centro Especializado de Enfermedades Neoplasicas SRL-CEEN SRL ( Site 0710)
Arequipa, 04000, Peru
Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 0704)
Arequipa, 04000, Peru
Clinica Internacional Sede San Borja ( Site 0701)
Lima, 15036, Peru
Hospital Nacional Cayetano Heredia ( Site 0706)
Lima, 15102, Peru
Clinica Peruano Americana S.A. ( Site 0703)
Trujillo, 13007, Peru
Dolnoslaskie Centrum Onkologii. ( Site 1616)
Wroclaw, Lower Silesian Voivodeship, 53-413, Poland
Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614)
Koszalin, West Pomeranian Voivodeship, 75-581, Poland
Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)
Brzeziny, 95-060, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609)
Bydgoszcz, 85-796, Poland
Przychodnia Lekarska Komed ( Site 1602)
Konin, 62-500, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)
Olsztyn, 10-357, Poland
MED-POLONIA Sp. z o.o. ( Site 1605)
Poznan, 60-693, Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600)
Warsaw, 02-781, Poland
Universitas Annex National Hospital ( Site 1800)
Bloemfontein, Free State, 9301, South Africa
Clinton Onclogy Clinic ( Site 1804)
Alberton, Gauteng, 1448, South Africa
Wilgers Oncology Centre ( Site 1808)
Pretoria, Gauteng, 0081, South Africa
Vincent Pallotti Hospital ( Site 1811)
Cape Town, 7405, South Africa
University of Stellenbosch and Tygerberg Hospital ( Site 1810)
Cape Town, 8000, South Africa
Dr G.A. Landers Specialist Oncologist ( Site 1803)
Durban, 4001, South Africa
Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806)
Johannesburg, 2193, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 1807)
Johannesburg, 2196, South Africa
GVI Oncology Clinical Research Centre ( Site 1802)
Kraaifontein, 7570, South Africa
Seoul National University Hospital ( Site 2303)
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System ( Site 2300)
Seoul, 03722, South Korea
Asan Medical Center ( Site 2302)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 2301)
Seoul, 06351, South Korea
Hospital Germans Trias i Pujol ( Site 1207)
Badalona, Barcelona, 08916, Spain
Hospital Duran i Reynals ( Site 1201)
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital San Pedro de Alcantara ( Site 1208)
Cáceres, Extremadura, 10003, Spain
Hospital Universitario Insular de Gran Canaria ( Site 1203)
Las Palmas de Gran Canaria, Gran Canaria, 35001, Spain
Hospital Universitari Vall d Hebron ( Site 1211)
Barcelona, 08035, Spain
Hospital Fundacion Jimenez Diaz - Clin. Concepcion ( Site 1209)
Madrid, 28040, Spain
Hospital Universitario Virgen del Rocio ( Site 1200)
Seville, 41013, Spain
Changhua Christian Hospital ( Site 2406)
Changhua, 50006, Taiwan
Chang Gung Medical Foundation - Kaohsiung ( Site 2404)
Kaohsiung City, 833, Taiwan
China Medical University Hospital ( Site 2403)
Taichung, 404, Taiwan
National Cheng Kung University Hospital ( Site 2401)
Tainan, 70457, Taiwan
National Taiwan University Hospital ( Site 2400)
Taipei, 10048, Taiwan
Mackay Memorial Hospital ( Site 2405)
Taipei, 104, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 2402)
Taoyuan District, 33305, Taiwan
Ramathibodi Hospital. ( Site 2563)
Ratchthevee, Bangkok, 10400, Thailand
Bangkok Hospital Chiangmai ( Site 2560)
Mueang, Chiang Mai, 50000, Thailand
Chulalongkorn Hospital ( Site 2561)
Bangkok, 10330, Thailand
Pramongkutklao Hospital ( Site 2564)
Bangkok, 10400, Thailand
Siriraj Hospital ( Site 2562)
Bangkok, 10700, Thailand
Khon Kaen University ( Site 2565)
Khon Kaen, 40002, Thailand
Acibadem Adana Hastanesi ( Site 1904)
Adana, 01130, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)
Ankara, 06100, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi ( Site 1914)
Bursa, 16059, Turkey (Türkiye)
Ankara Sehir Hastanesi ( Site 1903)
Cankaya - Ankara, 06490, Turkey (Türkiye)
Trakya Uni. Tip Fakultesi ( Site 1911)
Edirne, 22030, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)
Istanbul, 34098, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)
Istanbul, 34899, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)
Izmir, 35100, Turkey (Türkiye)
Medical Park Izmir Hospital ( Site 1900)
Izmir, 35575, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi ( Site 1909)
Kocaeli, 41380, Turkey (Türkiye)
Inonu Universitesi Tip Fakultesi ( Site 1907)
Malatya, 44280, Turkey (Türkiye)
Karadeniz Teknik Universitesi ( Site 1910)
Trabzon, 61080, Turkey (Türkiye)
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005)
Kryviy Rih, Dnipropetrovsk Oblast, 50048, Ukraine
Cherkasy Regional Hospital ( Site 2020)
Cherkasy, 18009, Ukraine
Regional Clinical Onco Dispensary_ State Medical University ( Site 2012)
Chernivtsy, 58013, Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC ( Site 2000)
Dnipropetrovsk, 49102, Ukraine
MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009)
Ivano-Frankivsk, 76018, Ukraine
PP PPC Acinus Medical and Diagnostic Centre ( Site 2002)
Kropyvnytskyi, 25006, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 2015)
Kyiv, 03002, Ukraine
Kyiv City Clinical Oncological Center ( Site 2014)
Kyiv, 03115, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2003)
Lviv, 79031, Ukraine
MI Odessa Regional Oncological Centre ( Site 2004)
Odesa, 65055, Ukraine
Royal Cornwall Hospital ( Site 1325)
Truro, Cornwall, TR1 3LJ, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 1326)
Sutton, Surrey, SM2 5PT, United Kingdom
Belfast City Hospital ( Site 1302)
Belfast, BT9 7AB, United Kingdom
Royal Free NHS Foundation Trust ( Site 1324)
London, NW3 2QG, United Kingdom
St. Georges University Hospital NHS Foundation Trust ( Site 1321)
London, SW17 0QT, United Kingdom
The Royal Marsden NHS Foundation Trust.. ( Site 1327)
London, SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust ( Site 1301)
Manchester, M20 4BX, United Kingdom
Mount Vernon Cancer Centre ( Site 1307)
Northwood, HA6 2RN, United Kingdom
Royal Wolverhampton Hospitals NHS Trust ( Site 1323)
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
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.
PMID: 33513313DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2017
First Posted
October 5, 2017
Study Start
December 14, 2017
Primary Completion
September 1, 2020
Study Completion
September 7, 2022
Last Updated
September 26, 2023
Results First Posted
September 10, 2021
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd