AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT03302234

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 study testing Pembrolizumab and Ipilimumab in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 187 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Pembrolizumab and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
568 participants
Where
187 sitesin 24 countries
Study dates
14 Dec 2017to 7 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

187 sites in 24 countries.

187 sites in 24 countries

United States25 sites

  • Texas Oncology-Arlington South ( Site 8006)

    Arlington, Texas, 76014

  • Boston Medical Center ( Site 0025)

    Boston, Massachusetts, 02118

  • Disney Family Cancer Center ( Site 0035)

    Burbank, California, 91505

  • Lahey Hospital & Medical Center ( Site 0020)

    Burlington, Massachusetts, 01805

  • University of Tennessee Erlanger Oncology & Hematology ( Site 0026)

    Chattanooga, Tennessee, 37403

  • The Ohio State University Wexner Medical Center ( Site 0016)

    Columbus, Ohio, 43210

  • Mid Ohio Oncology/Hematology Inc. ( Site 0003)

    Columbus, Ohio, 43219

  • Texas Oncology-Methodist Dallas Cancer Center ( Site 8000)

    Dallas, Texas, 75203

  • Texas Oncology-Flower Mound ( Site 8007)

    Flower Mound, Texas, 75028

  • Greenville Health System ( Site 8010)

    Greenville, South Carolina, 29615

  • Tennessee Cancer Specialists ( Site 0017)

    Knoxville, Tennessee, 37909

  • Texas Oncology-Longview Cancer Center ( Site 8009)

    Longview, Texas, 75601

  • University of Wisconsin Carbone Cancer Center ( Site 0004)

    Madison, Wisconsin, 53792

  • Medical College of Wisconsin Clinical Cancer Center ( Site 0027)

    Milwaukee, Wisconsin, 53226

  • Pacific Cancer Care ( Site 0001)

    Monterey, California, 93940

  • Icahn School of Medicine at Mount Sinai ( Site 0034)

    New York, New York, 10029

  • Florida Hospital Cancer Institute ( Site 0009)

    Orlando, Florida, 32804

  • Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018)

    Paducah, Kentucky, 42003

  • Mayo Clinic Cancer Center ( Site 0007)

    Phoenix, Arizona, 85054

  • Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031)

    Portland, Oregon, 97213

  • John Wayne Cancer Institute ( Site 0021)

    Santa Monica, California, 90404

  • New England Cancer Specialists ( Site 0019)

    Scarborough, Maine, 04074

  • Holy Name Medical Center ( Site 0022)

    Teaneck, New Jersey, 07666

  • Northwest Cancer Specialists, P.C. ( Site 8001)

    Vancouver, Washington, 98684

  • Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033)

    Yakima, Washington, 98902

Other trials in United States

Turkey (Türkiye)12 sites

  • Acibadem Adana Hastanesi ( Site 1904)

    Adana, 01130

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)

    Ankara, 06100

  • Uludag Universitesi Tip Fakultesi ( Site 1914)

    Bursa, 16059

  • Ankara Sehir Hastanesi ( Site 1903)

    Cankaya - Ankara, 06490

  • Trakya Uni. Tip Fakultesi ( Site 1911)

    Edirne, 22030

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)

    Istanbul, 34098

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)

    Istanbul, 34899

  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)

    Izmir, 35100

  • Medical Park Izmir Hospital ( Site 1900)

    Izmir, 35575

  • Kocaeli Universitesi Tip Fakultesi ( Site 1909)

    Kocaeli, 41380

  • Inonu Universitesi Tip Fakultesi ( Site 1907)

    Malatya, 44280

  • Karadeniz Teknik Universitesi ( Site 1910)

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Ukraine10 sites

  • Cherkasy Regional Hospital ( Site 2020)

    Cherkasy, 18009

  • Regional Clinical Onco Dispensary_ State Medical University ( Site 2012)

    Chernivtsy, 58013

  • Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC ( Site 2000)

    Dnipropetrovsk, 49102

  • MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009)

    Ivano-Frankivsk, 76018

  • PP PPC Acinus Medical and Diagnostic Centre ( Site 2002)

    Kropyvnytskyi, 25006

  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005)

    Kryviy Rih, Dnipropetrovsk Oblast, 50048

  • National Cancer Institute of the MoH of Ukraine ( Site 2015)

    Kyiv, 03002

  • Kyiv City Clinical Oncological Center ( Site 2014)

    Kyiv, 03115

  • Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2003)

    Lviv, 79031

  • MI Odessa Regional Oncological Centre ( Site 2004)

    Odesa, 65055

Other trials in Ukraine

Brazil9 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312)

    Barretos, 14784-400

  • CEPON Centro de Pesquisa Oncológicas ( Site 0307)

    Florianópolis, 88034-000

  • Hospital Nossa Senhora da Conceicao ( Site 0306)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0302)

    Recife, Pernambuco, 50070-550

  • Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)

    Santa Maria, Rio Grande do Sul, 97015-513

  • Instituto do Cancer de Sao Paulo - ICESP ( Site 0300)

    São Paulo, São Paulo, 01246-000

  • Hospital Alemao Oswaldo Cruz ( Site 0311)

    São Paulo, São Paulo, 01323-020

  • Escola Paulista de Medicina - UNIFESP ( Site 0304)

    São Paulo, São Paulo, 04024-002

  • Hospital do Servidor Publico do Estado ( Site 0308)

    São Paulo, 04039-004

Other trials in Brazil

France9 sites

  • Institut Bergonie ( Site 0803)

    Bordeaux, 33076

  • CHU de Brest. Hopital Morvan ( Site 0800)

    Brest, 29200

  • Centre Hopitalier Intercommunal Creteil ( Site 0802)

    Créteil, 94010

  • Centre Hospitalier Le Mans ( Site 0804)

    Le Mans, 72037

  • C.H.R.U de Lille - Hopital Calmette ( Site 0805)

    Lille, 59037

  • Hopital Nord du Marseille ( Site 0808)

    Marseille, Cedex 20, 13015

  • Hopital Tenon ( Site 0810)

    Paris, 75020

  • Nouvel Hopital Civil ( Site 0809)

    Strasbourg, 67091

  • CHU de Toulouse - Hopital Larrey ( Site 0801)

    Toulouse, 31059

Other trials in France

Hungary9 sites

  • Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502)

    Budapest, 1121

  • Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506)

    Budapest, 1122

  • Orszagos Onkologiai Intezet ( Site 1509)

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont ( Site 1511)

    Debrecen, 4032

  • Veszprem Megyei Tudogyogyintezet ( Site 1503)

    Farkasgyepű, 8582

  • Petz Aladar Megyei Oktato Korhaz ( Site 1505)

    Győr, 9024

  • Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)

    Gyula, 5700

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)

    Székesfehérvár, 8000

  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501)

    Szolnok, 5000

Other trials in Hungary

South Africa9 sites

  • Clinton Onclogy Clinic ( Site 1804)

    Alberton, Gauteng, 1448

  • Universitas Annex National Hospital ( Site 1800)

    Bloemfontein, Free State, 9301

  • Vincent Pallotti Hospital ( Site 1811)

    Cape Town, 7405

  • University of Stellenbosch and Tygerberg Hospital ( Site 1810)

    Cape Town, 8000

  • Dr G.A. Landers Specialist Oncologist ( Site 1803)

    Durban, 4001

  • Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806)

    Johannesburg, 2193

  • Sandton Oncology Medical Group PTY LTD ( Site 1807)

    Johannesburg, 2196

  • GVI Oncology Clinical Research Centre ( Site 1802)

    Kraaifontein, 7570

  • Wilgers Oncology Centre ( Site 1808)

    Pretoria, Gauteng, 0081

Other trials in South Africa

United Kingdom9 sites

  • Belfast City Hospital ( Site 1302)

    Belfast, BT9 7AB

  • Royal Free NHS Foundation Trust ( Site 1324)

    London, NW3 2QG

  • St. Georges University Hospital NHS Foundation Trust ( Site 1321)

    London, SW17 0QT

  • The Royal Marsden NHS Foundation Trust.. ( Site 1327)

    London, SW3 6JJ

  • The Christie NHS Foundation Trust ( Site 1301)

    Manchester, M20 4BX

  • Mount Vernon Cancer Centre ( Site 1307)

    Northwood, HA6 2RN

  • The Royal Marsden NHS Foundation Trust. ( Site 1326)

    Sutton, Surrey, SM2 5PT

  • Royal Cornwall Hospital ( Site 1325)

    Truro, Cornwall, TR1 3LJ

  • Royal Wolverhampton Hospitals NHS Trust ( Site 1323)

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Argentina8 sites

  • Hospital Aleman ( Site 0208)

    Buenos Aires, C1118AAT

  • Hospital Privado Centro Medico Cordoba ( Site 0206)

    Córdoba, X5016KEH

  • Centro Oncologico Riojano Integral ( Site 0203)

    La Rioja, F5300COE

  • Sanatorio Parque ( Site 0201)

    Rosario, Santa Fe Province, S2000DSV

  • Sanatorio Britanico ( Site 0205)

    Rosario, S2000CVB

  • Instituto de Oncologia de Rosario ( Site 0200)

    Rosario, S2000KZE

  • Centro Medico San Roque ( Site 0207)

    San Miguel de Tucumán, T4000IAK

  • Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202)

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Germany8 sites

  • Evangelische Lungenklinik Berlin ( Site 0903)

    Berlin, 13125

  • Vivantes Klinikum Spandau ( Site 0910)

    Berlin, 13585

  • HELIOS Klinikum Emil von Behring ( Site 0905)

    Berlin, 14165

  • SRH Waldklinikum Gera GmbH ( Site 0907)

    Gera, 07548

  • LungenClinic Grosshansdorf GmbH ( Site 0908)

    Großhansdorf, 22927

  • Universitaetsklinikum Heidelberg ( Site 0900)

    Heidelberg, 69126

  • Universitaetsklinikum Leipzig ( Site 0919)

    Leipzig, 04103

  • Universitaetsklinikum Schleswig Holstein. ( Site 0918)

    Lübeck, 23538

Other trials in Germany

Italy8 sites

  • ASST Spedali Civili ( Site 1001)

    Brescia, 25123

  • Ospedale Mater Salutis ( Site 1005)

    Legnago, Verona, 37045

  • Istituto Europeo di Oncologia ( Site 1007)

    Milan, 20141

  • Ospedale San Gerardo ASST Monza ( Site 1002)

    Monza, 20900

  • AORN dei Colli Plesso Monaldi ( Site 1003)

    Naples, 80131

  • Ospedale Santa Maria della Misericordia ( Site 1008)

    Perugia, 06132

  • Humanitas Research Hospital ( Site 1004)

    Rozzano, Milano, 20089

  • IRCCS Casa Sollievo della Sofferenza ( Site 1009)

    San Giovanni Rotondo (FG), Foggia, 71013

Other trials in Italy

Poland8 sites

  • Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)

    Brzeziny, 95-060

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609)

    Bydgoszcz, 85-796

  • Przychodnia Lekarska Komed ( Site 1602)

    Konin, 62-500

  • Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614)

    Koszalin, West Pomeranian Voivodeship, 75-581

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)

    Olsztyn, 10-357

  • MED-POLONIA Sp. z o.o. ( Site 1605)

    Poznan, 60-693

  • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600)

    Warsaw, 02-781

  • Dolnoslaskie Centrum Onkologii. ( Site 1616)

    Wroclaw, Lower Silesian Voivodeship, 53-413

Other trials in Poland

Canada7 sites

  • Tom Baker Cancer Centre ( Site 0119)

    Calgary, Alberta, T2N 4N2

  • CIUSSS du Saguenay-Lac-St-Jean ( Site 0115)

    Chicoutimi, Quebec, G7H 5H6

  • CISSS de la Monteregie-Centre ( Site 0100)

    Greenfield Park, Quebec, J4V 2H1

  • CISSS-CA Hotel-Dieu de Levis ( Site 0108)

    Lévis, Quebec, G6V 3Z1

  • CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107)

    Montreal, Quebec, H3T 1M5

  • St-Jerome Medical Research Inc ( Site 0113)

    Saint-Jérôme, Quebec, J7Z 5T3

  • CancerCare Manitoba ( Site 0106)

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Spain7 sites

  • Hospital Germans Trias i Pujol ( Site 1207)

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d Hebron ( Site 1211)

    Barcelona, 08035

  • Hospital San Pedro de Alcantara ( Site 1208)

    Cáceres, Extremadura, 10003

  • Hospital Duran i Reynals ( Site 1201)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Insular de Gran Canaria ( Site 1203)

    Las Palmas de Gran Canaria, Gran Canaria, 35001

  • Hospital Fundacion Jimenez Diaz - Clin. Concepcion ( Site 1209)

    Madrid, 28040

  • Hospital Universitario Virgen del Rocio ( Site 1200)

    Seville, 41013

Other trials in Spain

Taiwan7 sites

  • Changhua Christian Hospital ( Site 2406)

    Changhua, 50006

  • Chang Gung Medical Foundation - Kaohsiung ( Site 2404)

    Kaohsiung City, 833

  • China Medical University Hospital ( Site 2403)

    Taichung, 404

  • National Cheng Kung University Hospital ( Site 2401)

    Tainan, 70457

  • National Taiwan University Hospital ( Site 2400)

    Taipei, 10048

  • Mackay Memorial Hospital ( Site 2405)

    Taipei, 104

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 2402)

    Taoyuan, 33305

Other trials in Taiwan

Mexico6 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603)

    Guadalajara, Jalisco, 44200

  • Medical Care and Research S.A. de C.V. ( Site 0602)

    Mérida, Yucatán, 97070

  • Grupo Medico Camino SC ( Site 0607)

    Mexico City, 03310

  • Medica Sur S.A.B de C.V. ( Site 0608)

    Mexico City, 14050

  • Avix Investigacion Clinica S.C. ( Site 0600)

    Monterrey, N.L., 64710

  • Oncologica de Puebla SA de CV ( Site 0606)

    Puebla City, 72530

Other trials in Mexico

Peru6 sites

  • Centro Especializado de Enfermedades Neoplasicas SRL-CEEN SRL ( Site 0710)

    Arequipa, 04000

  • Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 0704)

    Arequipa, 04000

  • Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)

    La Victoria, Lima region, 15033

  • Clinica Internacional Sede San Borja ( Site 0701)

    Lima, 15036

  • Hospital Nacional Cayetano Heredia ( Site 0706)

    Lima, 15102

  • Clinica Peruano Americana S.A. ( Site 0703)

    Trujillo, 13007

Other trials in Peru

Thailand6 sites

  • Chulalongkorn Hospital ( Site 2561)

    Bangkok, 10330

  • Pramongkutklao Hospital ( Site 2564)

    Bangkok, 10400

  • Siriraj Hospital ( Site 2562)

    Bangkok, 10700

  • Khon Kaen University ( Site 2565)

    Khon Kaen, 40002

  • Bangkok Hospital Chiangmai ( Site 2560)

    Mueang, Chiang Mai, 50000

  • Ramathibodi Hospital. ( Site 2563)

    Ratchthevee, Bangkok, 10400

Other trials in Thailand

Australia5 sites

  • Chris OBrien Lifehouse ( Site 2100)

    Camperdown, 2050

  • The Townsville Hospital ( Site 2103)

    Douglas, 4814

  • St Vincents Hospital Melbourne ( Site 2101)

    Fitzroy, 3065

  • Fiona Stanley Hospital ( Site 2105)

    Perth, Western Australia, 6150

  • Mater Cancer Care Centre ( Site 2102)

    South Brisbane, Queensland, 4101

Other trials in Australia

Chile5 sites

  • Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401)

    Santiago, 7500006

  • Pontificia Universidad Catolica de Chile ( Site 0404)

    Santiago, 8330032

  • Instituto Nacional del Cancer ( Site 0406)

    Santiago, 8380455

  • Clinica Universidad Catolica del Maule ( Site 0413)

    Talca, El Maule, 3465584

  • Hospital Clinico Vina del Mar ( Site 0400)

    Viña del Mar, 2520000

Other trials in Chile

Colombia5 sites

  • Centro de Investigacion Clinica del Country ( Site 0500)

    Bogotá, 110221

  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506)

    Bogotá, 110311

  • Hospital Pablo Tobon Uribe ( Site 0505)

    Medellín, Antioquia, 050034

  • Oncomedica S.A. ( Site 0502)

    Montería, 230002

  • Instituto Cancerologico de Narino Ltda ( Site 0504)

    Pasto, 520001

Other trials in Colombia

South Korea4 sites

  • Seoul National University Hospital ( Site 2303)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 2300)

    Seoul, 03722

  • Asan Medical Center ( Site 2302)

    Seoul, 05505

  • Samsung Medical Center ( Site 2301)

    Seoul, 06351

Other trials in South Korea

Ireland3 sites

  • Beaumont Hospital ( Site 1312)

    Dublin, D09 V2N0

  • St James Hospital ( Site 1401)

    Dublin, Dublin 8

  • University Hospital Limerick ( Site 1403)

    Limerick, V94 F858

Other trials in Ireland

Latvia2 sites

  • Pauls Stradins Clinical University Hospital ( Site 1100)

    Riga, 1002

  • Riga East Clinical University Hospital ( Site 1111)

    Riga, 1079

Other trials in Latvia

About this study

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)

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.

Being tested
Pembrolizumab, Ipilimumab, Placebo
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called KEYTRUDA®, MK-3475

    Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

  • IpilimumabBiological

    Also called YERVOY®

    Administered as an IV infusion every 6 weeks (Q6W)

  • PlaceboOther

    Normal saline solution administered as an IV infusion Q6W

Study groups in NCT03302234
Study groupRoleWhat they receive
Pembrolizumab + IpilimumabExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Biological: Ipilimumab
Pembrolizumab + PlaceboActive 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.
Receives: Biological: Pembrolizumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 32 months (through data cut-off date: 01 Sep 2020)

  2. 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.

    Measured: Up to approximately 32 months (through data cut-off date 01 Sep 2020)

Secondary outcomes (6)

  1. Objective Response Rate (ORR) Per RECIST 1.1 Based on BICR

    ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by BICR. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per protocol the ORR was calculated using the Miettinen \& Nurminen method 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) for the first course of study treatment.

    Measured: Up to approximately 32 months (data cut-off date 01 Sep 2020)

  2. Duration of Response (DOR) Per RECIST 1.1 Based on BICR

    For participants who demonstrated a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. Per protocol, the DOR for all participants who experienced a CR or PR was presented for the first course of study treatment.

    Measured: Up to approximately 32 months (data cut-off date 01 Sep 2020)

  3. Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath

    TTD was defined as the time to the first onset of a 10-point or greater score deterioration from baseline in any one of the 3 symptoms (cough, pain in chest or shortness of breath), confirmed by a second adjacent 10-point or greater score deterioration from baseline. Cough was based on EORTC QLQ-LC13 question 1, pain in chest was based on EORTC QLQ-LC13 question 10, and shortness of breath was based on EORTC QLQ-C30 question 8. Per protocol, TTD was reported for first course study treatment.

    Measured: Up to approximately 32 months (data cut-off date 01 Sep 2020)

  4. Number of Participants Who Experienced an Adverse Event (AE)

    An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who experienced an AE were reported for the first course of study treatment and follow up.

    Measured: Up to approximately 27 months

  5. Number of Participants Who Discontinued Study Treatment Due to an AE

    An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for the first course of study treatment.

    Measured: Up to approximately 24 months

  6. 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

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score were presented for first course study treatment.

    Measured: Baseline, Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2017
  2. Study start14 Dec 2017
  3. Primary completion1 Sep 2020
  4. Study completion7 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
568 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03302234
Sponsor's protocol ID
3475-598
Other IDs
MK-3475-598, KEYNOTE-598, 2016-004364-20, 2016
Status last verified
Sep 2023
First submitted
26 Sep 2017
Last updated
26 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd

Publications

  • 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.

    PubMed 33513313

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab and Ipilimumab in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 187 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States, Turkey (Türkiye), Ukraine, Brazil, France and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 32 months (through data cut-off date: 01 Sep 2020)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03302234, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.

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