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Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-small Cell Lung Cancer (MK-3475-598/KEYNOTE-598)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03302234
Recruitment Status : Active, not recruiting
First Posted : October 5, 2017
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: pembrolizumab Biological: ipilimumab Other: placebo for ipilimumab Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 548 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 22, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pembrolizumab + ipilimumab
Participants 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.
Biological: pembrolizumab
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Other Names:
  • KEYTRUDA®
  • MK-3475

Biological: ipilimumab
Administered as an IV infusion every 6 weeks (Q6W)
Other Name: YERVOY®

Active Comparator: pembrolizumab + placebo
Participants 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.
Biological: pembrolizumab
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Other Names:
  • KEYTRUDA®
  • MK-3475

Other: placebo for ipilimumab
Normal saline solution administered as an IV infusion Q6W




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
    OS is the time from randomization to death due to any cause.

  2. Progression-free Survival (PFS) [ Time Frame: Up to approximately 2 years ]
    PFS is the time from randomization to first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR).


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]
    ORR is the proportion of the participants who achieve complete response (CR) or partial response (PR) per RECIST 1.1 by BICR.

  2. Duration Of Response (DOR) [ Time Frame: Up to approximately 2 years ]
    DOR is the time from first documented evidence of CR or PR per RECIST 1.1 by BICR until disease progression per RECIST 1.1 by BICR or death.

  3. Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath [ Time Frame: On study day 1 prior to initiation of study therapy (baseline) and up to approximately 2 years ]
    Time to true deterioration is defined as the time to the first onset of a 10-point or greater score decrease from study day 1 prior to initiation of study therapy (baseline) in any one of the 3 symptoms, confirmed by a second adjacent 10-point or greater score decrease from baseline. Cough is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer Module 13 (EORTC QLQ-LC13) question 1, pain in chest is based on EORTC QLQ-LC13 question 10, and shortness of breath is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) question 8.

  4. Incidence of Adverse Events (AEs) [ Time Frame: From time of signing the informed consent form (ICF) until the end of follow-up (up to approximately 118 Weeks). ]
    Percentage of participants experiencing any unfavorable and unintended sign, symptom, disease, or worsening of pre-existing condition temporally associated with study therapy and irrespective of causality to study therapy.

  5. Incidence of Discontinuations [ Time Frame: From time of signing the ICF until the end of study therapy (up to approximately 105 Weeks). ]
    Percentage of participants discontinuing study drug due to an AE.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a histologically or cytologically confirmed diagnosis of Stage IV metastatic NSCLC (American Joint Committee on Cancer version 8)
  • Has measurable disease per RECIST 1.1 as determined by investigator
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Has a life expectancy of >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 and male 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
  • Male participants must refrain from donating sperm 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), 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 or father 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 ROS1 translocation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302234


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Locations
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United States, Arizona
Mayo Clinic Cancer Center ( Site 0007)
Phoenix, Arizona, United States, 85054
United States, California
Disney Family Cancer Center ( Site 0035)
Burbank, California, United States, 91505
Pacific Cancer Care ( Site 0001)
Monterey, California, United States, 93940
John Wayne Cancer Institute ( Site 0021)
Santa Monica, California, United States, 90404
United States, Florida
Florida Hospital Cancer Institute ( Site 0009)
Orlando, Florida, United States, 32804
United States, Kentucky
Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018)
Paducah, Kentucky, United States, 42003
United States, Maine
New England Cancer Specialists ( Site 0019)
Scarborough, Maine, United States, 04074
United States, Massachusetts
Boston Medical Center ( Site 0025)
Boston, Massachusetts, United States, 02118
Lahey Hospital & Medical Center ( Site 0020)
Burlington, Massachusetts, United States, 01805
United States, New Jersey
Holy Name Medical Center ( Site 0022)
Teaneck, New Jersey, United States, 07666
United States, New York
Icahn School of Medicine at Mount Sinai ( Site 0034)
New York, New York, United States, 10029
United States, Ohio
The Ohio State University Wexner Medical Center ( Site 0016)
Columbus, Ohio, United States, 43210
Mid Ohio Oncology/Hematology Inc. ( Site 0003)
Columbus, Ohio, United States, 43219
United States, Oregon
Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031)
Portland, Oregon, United States, 97213
United States, South Carolina
Greenville Health System ( Site 8010)
Greenville, South Carolina, United States, 29615
United States, Tennessee
University of Tennessee Erlanger Oncology & Hematology ( Site 0026)
Chattanooga, Tennessee, United States, 37403
Tennessee Cancer Specialists ( Site 0017)
Knoxville, Tennessee, United States, 37909
United States, Texas
Texas Oncology-Arlington South ( Site 8006)
Arlington, Texas, United States, 76014
Texas Oncology-Methodist Dallas Cancer Center ( Site 8000)
Dallas, Texas, United States, 75203
Texas Oncology-Flower Mound ( Site 8007)
Flower Mound, Texas, United States, 75028
Texas Oncology-Longview Cancer Center ( Site 8009)
Longview, Texas, United States, 75601
United States, Washington
Northwest Cancer Specialists, P.C. ( Site 8001)
Vancouver, Washington, United States, 98684
Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033)
Yakima, Washington, United States, 98902
United States, Wisconsin
University of Wisconsin Carbone Cancer Center ( Site 0004)
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin Clinical Cancer Center ( Site 0027)
Milwaukee, Wisconsin, United States, 53226
Argentina
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202)
Viedma, Rio Negro, Argentina, R8500ACE
Sanatorio Parque ( Site 0201)
Rosario, Santa Fe, Argentina, S2000DSV
Hospital Aleman ( Site 0208)
Buenos Aires, Argentina, C1118AAT
Hospital Privado Centro Medico Cordoba ( Site 0206)
Cordoba, Argentina, X5016KEH
Centro Oncologico Riojano Integral ( Site 0203)
La Rioja, Argentina, F5300COE
Sanatorio Britanico ( Site 0205)
Rosario, Argentina, S2000CVB
Instituto de Oncologia de Rosario ( Site 0200)
Rosario, Argentina, S2000KZE
Centro Medico San Roque ( Site 0207)
Tucuman, Argentina, T4000IAK
Australia, Queensland
Mater Cancer Care Centre ( Site 2102)
South Brisbane, Queensland, Australia, 4101
Australia, Western Australia
Fiona Stanley Hospital ( Site 2105)
Perth, Western Australia, Australia, 6150
Australia
Chris OBrien Lifehouse ( Site 2100)
Camperdown, Australia, 2050
The Townsville Hospital ( Site 2103)
Douglas, Australia, 4814
St Vincents Hospital Melbourne ( Site 2101)
Fitzroy, Australia, 3065
Brazil
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0302)
Recife, Pernambuco, Brazil, 50070-550
Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)
Santa Maria, Rio Grande Do Sul, Brazil, 97015-513
Hospital Nossa Senhora da Conceicao ( Site 0306)
Porto Alegre, RS, Brazil, 91350-200
Instituto do Cancer de Sao Paulo - ICESP ( Site 0300)
Sao Paulo, SP, Brazil, 01246-000
Hospital Alemao Oswaldo Cruz ( Site 0311)
Sao Paulo, SP, Brazil, 01323-020
Escola Paulista de Medicina - UNIFESP ( Site 0304)
Sao Paulo, SP, Brazil, 04024-002
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312)
Barretos, Brazil, 14784-400
CEPON Centro de Pesquisa Oncológicas ( Site 0307)
Florianopolis, Brazil, 88034-000
Hospital do Servidor Publico do Estado ( Site 0308)
Sao Paulo, Brazil, 04039-004
Canada, Alberta
Tom Baker Cancer Centre ( Site 0119)
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
CancerCare Manitoba ( Site 0106)
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Quebec
CIUSSS du Saguenay-Lac-St-Jean ( Site 0115)
Chicoutimi, Quebec, Canada, G7H 5H6
CISSS de la Monteregie-Centre ( Site 0100)
Greenfield Park, Quebec, Canada, J4V 2H1
CISSS-CA Hotel-Dieu de Levis ( Site 0108)
Levis, Quebec, Canada, G6V 3Z1
CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107)
Montreal, Quebec, Canada, H3T 1M5
St-Jerome Medical Research Inc ( Site 0113)
St-Jerome, Quebec, Canada, J7Z 5T3
Chile
Clinica Universidad Catolica del Maule ( Site 0413)
Talca, El Maule, Chile, 3465584
Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401)
Santiago, Chile, 7500006
Pontificia Universidad Catolica de Chile ( Site 0404)
Santiago, Chile, 8330032
Instituto Nacional del Cancer ( Site 0406)
Santiago, Chile, 8380455
Hospital Clinico Vina del Mar ( Site 0400)
Vina del Mar, Chile, 2520000
Colombia
Hospital Pablo Tobon Uribe ( Site 0505)
Medellin, Antioquia, Colombia, 050034
Centro de Investigacion Clinica del Country ( Site 0500)
Bogota, Colombia, 110221
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506)
Bogota, Colombia, 110311
Oncomedica S.A. ( Site 0502)
Monteria, Colombia, 230002
Instituto Cancerologico de Narino Ltda ( Site 0504)
Pasto, Colombia, 520001
France
Hopital Nord du Marseille ( Site 0808)
Marseille, Cedex 20, France, 13015
Institut Bergonie ( Site 0803)
Bordeaux, France, 33076
CHU de Brest. Hopital Morvan ( Site 0800)
Brest, France, 29200
Centre Hopitalier Intercommunal Creteil ( Site 0802)
Creteil, France, 94010
Centre Hospitalier Le Mans ( Site 0804)
Le Mans, France, 72037
C.H.R.U de Lille - Hopital Calmette ( Site 0805)
Lille, France, 59037
Hopital Tenon ( Site 0810)
Paris, France, 75020
Nouvel Hopital Civil ( Site 0809)
Strasbourg, France, 67091
CHU de Toulouse - Hopital Larrey ( Site 0801)
Toulouse, France, 31059
Germany
Evangelische Lungenklinik Berlin ( Site 0903)
Berlin, Germany, 13125
Vivantes Klinikum Spandau ( Site 0910)
Berlin, Germany, 13585
HELIOS Klinikum Emil von Behring ( Site 0905)
Berlin, Germany, 14165
SRH Waldklinikum Gera GmbH ( Site 0907)
Gera, Germany, 07548
LungenClinic Grosshansdorf GmbH ( Site 0908)
Grosshansdorf, Germany, 22927
Universitaetsklinikum Heidelberg ( Site 0900)
Heidelberg, Germany, 69126
Universitaetsklinikum Leipzig ( Site 0919)
Leipzig, Germany, 04103
Universitaetsklinikum Schleswig Holstein. ( Site 0918)
Luebeck, Germany, 23538
Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502)
Budapest, Hungary, 1121
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506)
Budapest, Hungary, 1122
Orszagos Onkologiai Intezet ( Site 1509)
Budapest, Hungary, 1122
Debreceni Egyetem Klinikai Kozpont ( Site 1511)
Debrecen, Hungary, 4032
Veszprem Megyei Tudogyogyintezet ( Site 1503)
Farkasgyepu, Hungary, 8582
Petz Aladar Megyei Oktato Korhaz ( Site 1505)
Gyor, Hungary, 9024
Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)
Gyula, Hungary, 5700
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)
Szekesfehervar, Hungary, 8000
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501)
Szolnok, Hungary, 5000
Ireland
Beaumont Hospital ( Site 1312)
Dublin, Ireland, D09 V2N0
St James Hospital ( Site 1401)
Dublin, Ireland, Dublin 8
University Hospital Limerick ( Site 1403)
Limerick, Ireland, V94 F858
Italy
IRCCS Casa Sollievo della Sofferenza ( Site 1009)
San Giovanni Rotondo (FG), Foggia, Italy, 71013
Humanitas Research Hospital ( Site 1004)
Rozzano, Milano, Italy, 20089
Ospedale Mater Salutis ( Site 1005)
Legnago, Verona, Italy, 37045
ASST Spedali Civili ( Site 1001)
Brescia, Italy, 25123
Istituto Europeo di Oncologia ( Site 1007)
Milano, Italy, 20141
Ospedale San Gerardo ASST Monza ( Site 1002)
Monza, Italy, 20900
AORN dei Colli Plesso Monaldi ( Site 1003)
Napoli, Italy, 80131
Ospedale Santa Maria della Misericordia ( Site 1008)
Perugia, Italy, 06132
Korea, Republic of
Seoul National University Hospital ( Site 2303)
Seoul, Korea, Republic of, 03080
Severance Hospital Yonsei University Health System ( Site 2300)
Seoul, Korea, Republic of, 03722
Asan Medical Center ( Site 2302)
Seoul, Korea, Republic of, 05505
Samsung Medical Center ( Site 2301)
Seoul, Korea, Republic of, 06351
Latvia
Pauls Stradins Clinical University Hospital ( Site 1100)
Riga, Latvia, 1002
Riga East Clinical University Hospital ( Site 1111)
Riga, Latvia, 1079
Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603)
Guadalajara, Jalisco, Mexico, 44200
Avix Investigacion Clinica S.C. ( Site 0600)
Monterrey, N.l., Mexico, 64710
Medical Care and Research S.A. de C.V. ( Site 0602)
Merida, Yucatan, Mexico, 97070
Grupo Medico Camino SC ( Site 0607)
Ciudad de Mexico, Mexico, 03310
Medica Sur S.A.B de C.V. ( Site 0608)
Mexico City, Mexico, 14050
Oncologica de Puebla SA de CV ( Site 0606)
Puebla, Mexico, 72530
Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)
La Victoria, Lima, Peru, 15033
Centro Especializado de Enfermedades Neoplasicas SRL-CEEN SRL ( Site 0710)
Arequipa, Peru, 04000
Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 0704)
Arequipa, Peru, 04000
Clinica Internacional Sede San Borja ( Site 0701)
Lima, Peru, 15036
Hospital Nacional Cayetano Heredia ( Site 0706)
Lima, Peru, 15102
Clinica Peruano Americana S.A. ( Site 0703)
Trujillo, Peru, 13007
Poland
Dolnoslaskie Centrum Onkologii. ( Site 1616)
Wroclaw, Dolnoslaskie, Poland, 53-413
Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614)
Koszalin, Zachodniopomorskie, Poland, 75-581
Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)
Brzeziny, Poland, 95-060
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609)
Bydgoszcz, Poland, 85-796
Przychodnia Lekarska Komed ( Site 1602)
Konin, Poland, 62-500
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)
Olsztyn, Poland, 10-357
MED-POLONIA Sp. z o.o. ( Site 1605)
Poznan, Poland, 60-693
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600)
Warszawa, Poland, 02-781
South Africa
Universitas Annex National Hospital ( Site 1800)
Bloemfontein, Free State, South Africa, 9301
Clinton Onclogy Clinic ( Site 1804)
Alberton, Gauteng, South Africa, 1448
Wilgers Oncology Centre ( Site 1808)
Pretoria, Gauteng, South Africa, 0081
Vincent Pallotti Hospital ( Site 1811)
Cape Town, South Africa, 7405
University of Stellenbosch and Tygerberg Hospital ( Site 1810)
Cape Town, South Africa, 8000
Dr G.A. Landers Specialist Oncologist ( Site 1803)
Durban, South Africa, 4001
Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806)
Johannesburg, South Africa, 2193
Sandton Oncology Medical Group PTY LTD ( Site 1807)
Johannesburg, South Africa, 2196
GVI Oncology Clinical Research Centre ( Site 1802)
Kraaifontein, South Africa, 7570
Spain
Hospital Germans Trias i Pujol ( Site 1207)
Badalona, Barcelona, Spain, 08916
Hospital Duran i Reynals ( Site 1201)
Hospitalet de Llobregat, Barcelona, Spain, 08908
Hospital San Pedro de Alcantara ( Site 1208)
Caceres, Extremadura, Spain, 10003
Hospital Universitario Insular de Gran Canaria ( Site 1203)
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35001
Hospital Universitari Vall d Hebron ( Site 1211)
Barcelona, Spain, 08035
Hospital Fundacion Jimenez Diaz - Clin. Concepcion ( Site 1209)
Madrid, Spain, 28040
Hospital Universitario Virgen del Rocio ( Site 1200)
Sevilla, Spain, 41013
Taiwan
Changhua Christian Hospital ( Site 2406)
Changhua, Taiwan, 50006
Chang Gung Medical Foundation - Kaohsiung ( Site 2404)
Kaohsiung, Taiwan, 833
China Medical University Hospital ( Site 2403)
Taichung, Taiwan, 404
National Cheng Kung University Hospital ( Site 2401)
Tainan, Taiwan, 70457
National Taiwan University Hospital ( Site 2400)
Taipei, Taiwan, 10048
Mackay Memorial Hospital ( Site 2405)
Taipei, Taiwan, 104
Chang Gung Memorial Hospital - Linkou Branch ( Site 2402)
Taoyuan, Taiwan, 33305
Thailand
Ramathibodi Hospital. ( Site 2563)
Ratchthevee, Bangkok, Thailand, 10400
Bangkok Hospital Chiangmai ( Site 2560)
Mueang, Chiang Mai, Thailand, 50000
Chulalongkorn Hospital ( Site 2561)
Bangkok, Thailand, 10330
Pramongkutklao Hospital ( Site 2564)
Bangkok, Thailand, 10400
Siriraj Hospital ( Site 2562)
Bangkok, Thailand, 10700
Khon Kaen University ( Site 2565)
Khon Kaen, Thailand, 40002
Turkey
Acibadem Adana Hastanesi ( Site 1904)
Adana, Turkey, 01130
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)
Ankara, Turkey, 06100
Uludag Universitesi Tip Fakultesi ( Site 1914)
Bursa, Turkey, 16059
Ankara Sehir Hastanesi ( Site 1903)
Cankaya - Ankara, Turkey, 06490
Trakya Uni. Tip Fakultesi ( Site 1911)
Edirne, Turkey, 22030
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)
Istanbul, Turkey, 34098
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)
Istanbul, Turkey, 34899
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)
Izmir, Turkey, 35100
Medical Park Izmir Hospital ( Site 1900)
Izmir, Turkey, 35575
Kocaeli Universitesi Tip Fakultesi ( Site 1909)
Kocaeli, Turkey, 41380
Inonu Universitesi Tip Fakultesi ( Site 1907)
Malatya, Turkey, 44280
Karadeniz Teknik Universitesi ( Site 1910)
Trabzon, Turkey, 61080
Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005)
Kryviy Rih, Dnipropetrovsk Region, Ukraine, 50048
Cherkasy Regional Hospital ( Site 2020)
Cherkasy, Ukraine, 18009
Regional Clinical Onco Dispensary_ State Medical University ( Site 2012)
Chernivtsy, Ukraine, 58013
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC ( Site 2000)
Dnipropetrovsk, Ukraine, 49102
MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009)
Ivano-Frankivsk, Ukraine, 76018
PP PPC Acinus Medical and Diagnostic Centre ( Site 2002)
Kropyvnytskyi, Ukraine, 25006
National Cancer Institute of the MoH of Ukraine ( Site 2015)
Kyiv, Ukraine, 03002
Kyiv City Clinical Oncological Center ( Site 2014)
Kyiv, Ukraine, 03115
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2003)
Lviv, Ukraine, 79031
MI Odessa Regional Oncological Centre ( Site 2004)
Odesa, Ukraine, 65055
United Kingdom
Royal Cornwall Hospital ( Site 1325)
Truro, Cornwall, United Kingdom, TR1 3LJ
The Royal Marsden NHS Foundation Trust. ( Site 1326)
Sutton, Surrey, United Kingdom, SM2 5PT
Belfast City Hospital ( Site 1302)
Belfast, United Kingdom, BT9 7AB
Royal Free NHS Foundation Trust ( Site 1324)
London, United Kingdom, NW3 2QG
St. Georges University Hospital NHS Foundation Trust ( Site 1321)
London, United Kingdom, SW17 0QT
The Royal Marsden NHS Foundation Trust.. ( Site 1327)
London, United Kingdom, SW3 6JJ
The Christie NHS Foundation Trust ( Site 1301)
Manchester, United Kingdom, M20 4BX
Mount Vernon Cancer Centre ( Site 1307)
Northwood, United Kingdom, HA6 2RN
Royal Wolverhampton Hospitals NHS Trust ( Site 1323)
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03302234     History of Changes
Other Study ID Numbers: 3475-598
2016-004364-20 ( EudraCT Number )
MK-3475-598 ( Other Identifier: Merck Registration Number )
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
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
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents