Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

568

Study ID:

NCT03302234

Recruitment Status:

Completed

Sponsor:

Merck Sharp & Dohme LLC

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There are 181 Locations for this study

See Locations Near You

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 Rio Negro, R8500, Argentina
Sanatorio Parque ( Site 0201)
Rosario Santa Fe, S2000, Argentina
Hospital Aleman ( Site 0208)
Buenos Aires , C1118, Argentina
Hospital Privado Centro Medico Cordoba ( Site 0206)
Cordoba , X5016, Argentina
Centro Oncologico Riojano Integral ( Site 0203)
La Rioja , F5300, Argentina
Sanatorio Britanico ( Site 0205)
Rosario , S2000, Argentina
Instituto de Oncologia de Rosario ( Site 0200)
Rosario , S2000, Argentina
Centro Medico San Roque ( Site 0207)
Tucuman , T4000, 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, Brazil
Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)
Santa Maria Rio Grande Do Sul, 97015, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0306)
Porto Alegre RS, 91350, Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 0300)
Sao Paulo SP, 01246, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0311)
Sao Paulo SP, 01323, Brazil
Escola Paulista de Medicina - UNIFESP ( Site 0304)
Sao Paulo SP, 04024, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312)
Barretos , 14784, Brazil
CEPON Centro de Pesquisa Oncológicas ( Site 0307)
Florianopolis , 88034, Brazil
Hospital do Servidor Publico do Estado ( Site 0308)
Sao Paulo , 04039, Brazil
Tom Baker Cancer Centre ( Site 0119)
Calgary Alberta, T2N 4, Canada
CancerCare Manitoba ( Site 0106)
Winnipeg Manitoba, R3E 0, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0115)
Chicoutimi Quebec, G7H 5, Canada
CISSS de la Monteregie-Centre ( Site 0100)
Greenfield Park Quebec, J4V 2, Canada
CISSS-CA Hotel-Dieu de Levis ( Site 0108)
Levis Quebec, G6V 3, Canada
CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107)
Montreal Quebec, H3T 1, Canada
St-Jerome Medical Research Inc ( Site 0113)
St-Jerome Quebec, J7Z 5, Canada
Clinica Universidad Catolica del Maule ( Site 0413)
Talca El Maule, 34655, Chile
Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401)
Santiago , 75000, Chile
Pontificia Universidad Catolica de Chile ( Site 0404)
Santiago , 83300, Chile
Instituto Nacional del Cancer ( Site 0406)
Santiago , 83804, Chile
Hospital Clinico Vina del Mar ( Site 0400)
Vina del Mar , 25200, Chile
Hospital Pablo Tobon Uribe ( Site 0505)
Medellin Antioquia, 05003, Colombia
Centro de Investigacion Clinica del Country ( Site 0500)
Bogota , 11022, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506)
Bogota , 11031, Colombia
Oncomedica S.A. ( Site 0502)
Monteria , 23000, Colombia
Instituto Cancerologico de Narino Ltda ( Site 0504)
Pasto , 52000, 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)
Creteil , 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)
Luebeck , 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)
Farkasgyepu , 8582, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1505)
Gyor , 9024, Hungary
Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)
Gyula , 5700, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)
Szekesfehervar , 8000, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501)
Szolnok , 5000, Hungary
Beaumont Hospital ( Site 1312)
Dublin , D09 V, Ireland
St James Hospital ( Site 1401)
Dublin , Dubli, Ireland
University Hospital Limerick ( Site 1403)
Limerick , V94 F, 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)
Milano , 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
Seoul National University Hospital ( Site 2303)
Seoul , 03080, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 2300)
Seoul , 03722, Korea, Republic of
Asan Medical Center ( Site 2302)
Seoul , 05505, Korea, Republic of
Samsung Medical Center ( Site 2301)
Seoul , 06351, Korea, Republic of
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)
Merida Yucatan, 97070, Mexico
Grupo Medico Camino SC ( Site 0607)
Ciudad de Mexico , 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 , 72530, Mexico
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)
La Victoria Lima, 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 Dolnoslaskie, 53-41, Poland
Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614)
Koszalin Zachodniopomorskie, 75-58, Poland
Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)
Brzeziny , 95-06, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609)
Bydgoszcz , 85-79, Poland
Przychodnia Lekarska Komed ( Site 1602)
Konin , 62-50, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)
Olsztyn , 10-35, Poland
MED-POLONIA Sp. z o.o. ( Site 1605)
Poznan , 60-69, Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600)
Warszawa , 02-78, 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
Hospital Germans Trias i Pujol ( Site 1207)
Badalona Barcelona, 08916, Spain
Hospital Duran i Reynals ( Site 1201)
Hospitalet de Llobregat Barcelona, 08908, Spain
Hospital San Pedro de Alcantara ( Site 1208)
Caceres 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)
Sevilla , 41013, Spain
Changhua Christian Hospital ( Site 2406)
Changhua , 50006, Taiwan
Chang Gung Medical Foundation - Kaohsiung ( Site 2404)
Kaohsiung , 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 , 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
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)
Ankara , 06100, Turkey
Uludag Universitesi Tip Fakultesi ( Site 1914)
Bursa , 16059, Turkey
Ankara Sehir Hastanesi ( Site 1903)
Cankaya - Ankara , 06490, Turkey
Trakya Uni. Tip Fakultesi ( Site 1911)
Edirne , 22030, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)
Istanbul , 34098, Turkey
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)
Istanbul , 34899, Turkey
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)
Izmir , 35100, Turkey
Medical Park Izmir Hospital ( Site 1900)
Izmir , 35575, Turkey
Kocaeli Universitesi Tip Fakultesi ( Site 1909)
Kocaeli , 41380, Turkey
Inonu Universitesi Tip Fakultesi ( Site 1907)
Malatya , 44280, Turkey
Karadeniz Teknik Universitesi ( Site 1910)
Trabzon , 61080, Turkey
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005)
Kryviy Rih Dnipropetrovsk Region, 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 3, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 1326)
Sutton Surrey, SM2 5, United Kingdom
Belfast City Hospital ( Site 1302)
Belfast , BT9 7, United Kingdom
Royal Free NHS Foundation Trust ( Site 1324)
London , NW3 2, United Kingdom
St. Georges University Hospital NHS Foundation Trust ( Site 1321)
London , SW17 , United Kingdom
The Royal Marsden NHS Foundation Trust.. ( Site 1327)
London , SW3 6, United Kingdom
The Christie NHS Foundation Trust ( Site 1301)
Manchester , M20 4, United Kingdom
Mount Vernon Cancer Centre ( Site 1307)
Northwood , HA6 2, United Kingdom
Royal Wolverhampton Hospitals NHS Trust ( Site 1323)
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

568

Study ID:

NCT03302234

Recruitment Status:

Completed

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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