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

NCT ID: NCT03302234

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 568 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2022-09-07

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

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

Ipilimumab

Intervention Type: BIOLOGICAL

Administered as an IV infusion every 6 weeks (Q6W)

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.

Group Type: ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type: BIOLOGICAL

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

Placebo

Intervention Type: OTHER

Normal saline solution administered as an IV infusion Q6W

Interventions

Pembrolizumab

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

Intervention Type: BIOLOGICAL

Ipilimumab

Administered as an IV infusion every 6 weeks (Q6W)

Intervention Type: BIOLOGICAL

Placebo

Normal saline solution administered as an IV infusion Q6W

Intervention Type: OTHER

Other Intervention Names

KEYTRUDA®; MK-3475; YERVOY®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Mayo Clinic Cancer Center ( Site 0007)

Phoenix, Arizona, United States

Disney Family Cancer Center ( Site 0035)

Burbank, California, United States

Pacific Cancer Care ( Site 0001)

Monterey, California, United States

John Wayne Cancer Institute ( Site 0021)

Santa Monica, California, United States

Florida Hospital Cancer Institute ( Site 0009)

Orlando, Florida, United States

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

Paducah, Kentucky, United States

New England Cancer Specialists ( Site 0019)

Scarborough, Maine, United States

Boston Medical Center ( Site 0025)

Boston, Massachusetts, United States

Lahey Hospital & Medical Center ( Site 0020)

Burlington, Massachusetts, United States

Holy Name Medical Center ( Site 0022)

Teaneck, New Jersey, United States

Icahn School of Medicine at Mount Sinai ( Site 0034)

New York, New York, United States

The Ohio State University Wexner Medical Center ( Site 0016)

Columbus, Ohio, United States

Mid Ohio Oncology/Hematology Inc. ( Site 0003)

Columbus, Ohio, United States

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

Portland, Oregon, United States

Greenville Health System ( Site 8010)

Greenville, South Carolina, United States

University of Tennessee Erlanger Oncology & Hematology ( Site 0026)

Chattanooga, Tennessee, United States

Tennessee Cancer Specialists ( Site 0017)

Knoxville, Tennessee, United States

Texas Oncology-Arlington South ( Site 8006)

Arlington, Texas, United States

Texas Oncology-Methodist Dallas Cancer Center ( Site 8000)

Dallas, Texas, United States

Texas Oncology-Flower Mound ( Site 8007)

Flower Mound, Texas, United States

Texas Oncology-Longview Cancer Center ( Site 8009)

Longview, Texas, United States

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

Vancouver, Washington, United States

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

Yakima, Washington, United States

University of Wisconsin Carbone Cancer Center ( Site 0004)

Madison, Wisconsin, United States

Medical College of Wisconsin Clinical Cancer Center ( Site 0027)

Milwaukee, Wisconsin, United States

Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202)

Viedma, Río Negro Province, Argentina

Sanatorio Parque ( Site 0201)

Rosario, Santa Fe Province, Argentina

Hospital Aleman ( Site 0208)

Buenos Aires, , Argentina

Hospital Privado Centro Medico Cordoba ( Site 0206)

Córdoba, , Argentina

Centro Oncologico Riojano Integral ( Site 0203)

La Rioja, , Argentina

Sanatorio Britanico ( Site 0205)

Rosario, , Argentina

Instituto de Oncologia de Rosario ( Site 0200)

Rosario, , Argentina

Centro Medico San Roque ( Site 0207)

San Miguel de Tucumán, , Argentina

Mater Cancer Care Centre ( Site 2102)

South Brisbane, Queensland, Australia

Fiona Stanley Hospital ( Site 2105)

Perth, Western Australia, Australia

Chris OBrien Lifehouse ( Site 2100)

Camperdown, , Australia

The Townsville Hospital ( Site 2103)

Douglas, , Australia

St Vincents Hospital Melbourne ( Site 2101)

Fitzroy, , Australia

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

Recife, Pernambuco, Brazil

Hospital Nossa Senhora da Conceicao ( Site 0306)

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)

Santa Maria, Rio Grande do Sul, Brazil

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

São Paulo, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz ( Site 0311)

São Paulo, São Paulo, Brazil

Escola Paulista de Medicina - UNIFESP ( Site 0304)

São Paulo, São Paulo, Brazil

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

Barretos, , Brazil

CEPON Centro de Pesquisa Oncológicas ( Site 0307)

Florianópolis, , Brazil

Hospital do Servidor Publico do Estado ( Site 0308)

São Paulo, , Brazil

Tom Baker Cancer Centre ( Site 0119)

Calgary, Alberta, Canada

CancerCare Manitoba ( Site 0106)

Winnipeg, Manitoba, Canada

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

Chicoutimi, Quebec, Canada

CISSS de la Monteregie-Centre ( Site 0100)

Greenfield Park, Quebec, Canada

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

Lévis, Quebec, Canada

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

Montreal, Quebec, Canada

St-Jerome Medical Research Inc ( Site 0113)

Saint-Jérôme, Quebec, Canada

Clinica Universidad Catolica del Maule ( Site 0413)

Talca, El Maule, Chile

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

Santiago, , Chile

Pontificia Universidad Catolica de Chile ( Site 0404)

Santiago, , Chile

Instituto Nacional del Cancer ( Site 0406)

Santiago, , Chile

Hospital Clinico Vina del Mar ( Site 0400)

Viña del Mar, , Chile

Hospital Pablo Tobon Uribe ( Site 0505)

Medellín, Antioquia, Colombia

Centro de Investigacion Clinica del Country ( Site 0500)

Bogotá, , Colombia

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

Bogotá, , Colombia

Oncomedica S.A. ( Site 0502)

Montería, , Colombia

Instituto Cancerologico de Narino Ltda ( Site 0504)

Pasto, , Colombia

Hopital Nord du Marseille ( Site 0808)

Marseille, Cedex 20, France

Institut Bergonie ( Site 0803)

Bordeaux, , France

CHU de Brest. Hopital Morvan ( Site 0800)

Brest, , France

Centre Hopitalier Intercommunal Creteil ( Site 0802)

Créteil, , France

Centre Hospitalier Le Mans ( Site 0804)

Le Mans, , France

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

Lille, , France

Hopital Tenon ( Site 0810)

Paris, , France

Nouvel Hopital Civil ( Site 0809)

Strasbourg, , France

CHU de Toulouse - Hopital Larrey ( Site 0801)

Toulouse, , France

Evangelische Lungenklinik Berlin ( Site 0903)

Berlin, , Germany

Vivantes Klinikum Spandau ( Site 0910)

Berlin, , Germany

HELIOS Klinikum Emil von Behring ( Site 0905)

Berlin, , Germany

SRH Waldklinikum Gera GmbH ( Site 0907)

Gera, , Germany

LungenClinic Grosshansdorf GmbH ( Site 0908)

Großhansdorf, , Germany

Universitaetsklinikum Heidelberg ( Site 0900)

Heidelberg, , Germany

Universitaetsklinikum Leipzig ( Site 0919)

Leipzig, , Germany

Universitaetsklinikum Schleswig Holstein. ( Site 0918)

Lübeck, , Germany

Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502)

Budapest, , Hungary

Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506)

Budapest, , Hungary

Orszagos Onkologiai Intezet ( Site 1509)

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 1511)

Debrecen, , Hungary

Veszprem Megyei Tudogyogyintezet ( Site 1503)

Farkasgyepű, , Hungary

Petz Aladar Megyei Oktato Korhaz ( Site 1505)

Győr, , Hungary

Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)

Gyula, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)

Székesfehérvár, , Hungary

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

Szolnok, , Hungary

Beaumont Hospital ( Site 1312)

Dublin, , Ireland

St James Hospital ( Site 1401)

Dublin, , Ireland

University Hospital Limerick ( Site 1403)

Limerick, , Ireland

IRCCS Casa Sollievo della Sofferenza ( Site 1009)

San Giovanni Rotondo (FG), Foggia, Italy

Humanitas Research Hospital ( Site 1004)

Rozzano, Milano, Italy

Ospedale Mater Salutis ( Site 1005)

Legnago, Verona, Italy

ASST Spedali Civili ( Site 1001)

Brescia, , Italy

Istituto Europeo di Oncologia ( Site 1007)

Milan, , Italy

Ospedale San Gerardo ASST Monza ( Site 1002)

Monza, , Italy

AORN dei Colli Plesso Monaldi ( Site 1003)

Napoli, , Italy

Ospedale Santa Maria della Misericordia ( Site 1008)

Perugia, , Italy

Pauls Stradins Clinical University Hospital ( Site 1100)

Riga, , Latvia

Riga East Clinical University Hospital ( Site 1111)

Riga, , Latvia

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603)

Guadalajara, Jalisco, Mexico

Avix Investigacion Clinica S.C. ( Site 0600)

Monterrey, N.L., Mexico

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

Mérida, Yucatán, Mexico

Grupo Medico Camino SC ( Site 0607)

Mexico City, , Mexico

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

Mexico City, , Mexico

Oncologica de Puebla SA de CV ( Site 0606)

Puebla City, , Mexico

Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)

La Victoria, Lima region, Peru

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

Arequipa, , Peru

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

Arequipa, , Peru

Clinica Internacional Sede San Borja ( Site 0701)

Lima, , Peru

Hospital Nacional Cayetano Heredia ( Site 0706)

Lima, , Peru

Clinica Peruano Americana S.A. ( Site 0703)

Trujillo, , Peru

Dolnoslaskie Centrum Onkologii. ( Site 1616)

Wroclaw, Lower Silesian Voivodeship, Poland

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

Koszalin, West Pomeranian Voivodeship, Poland

Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)

Brzeziny, , Poland

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

Bydgoszcz, , Poland

Przychodnia Lekarska Komed ( Site 1602)

Konin, , Poland

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)

Olsztyn, , Poland

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

Poznan, , Poland

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

Warsaw, , Poland

Universitas Annex National Hospital ( Site 1800)

Bloemfontein, Free State, South Africa

Clinton Onclogy Clinic ( Site 1804)

Alberton, Gauteng, South Africa

Wilgers Oncology Centre ( Site 1808)

Pretoria, Gauteng, South Africa

Vincent Pallotti Hospital ( Site 1811)

Cape Town, , South Africa

University of Stellenbosch and Tygerberg Hospital ( Site 1810)

Cape Town, , South Africa

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

Durban, , South Africa

Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806)

Johannesburg, , South Africa

Sandton Oncology Medical Group PTY LTD ( Site 1807)

Johannesburg, , South Africa

GVI Oncology Clinical Research Centre ( Site 1802)

Kraaifontein, , South Africa

Seoul National University Hospital ( Site 2303)

Seoul, , South Korea

Severance Hospital Yonsei University Health System ( Site 2300)

Seoul, , South Korea

Asan Medical Center ( Site 2302)

Seoul, , South Korea

Samsung Medical Center ( Site 2301)

Seoul, , South Korea

Hospital Germans Trias i Pujol ( Site 1207)

Badalona, Barcelona, Spain

Hospital Duran i Reynals ( Site 1201)

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital San Pedro de Alcantara ( Site 1208)

Cáceres, Extremadura, Spain

Hospital Universitario Insular de Gran Canaria ( Site 1203)

Las Palmas de Gran Canaria, Gran Canaria, Spain

Hospital Universitari Vall d Hebron ( Site 1211)

Barcelona, , Spain

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

Madrid, , Spain

Hospital Universitario Virgen del Rocio ( Site 1200)

Seville, , Spain

Changhua Christian Hospital ( Site 2406)

Changhua, , Taiwan

Chang Gung Medical Foundation - Kaohsiung ( Site 2404)

Kaohsiung City, , Taiwan

China Medical University Hospital ( Site 2403)

Taichung, , Taiwan

National Cheng Kung University Hospital ( Site 2401)

Tainan City, , Taiwan

National Taiwan University Hospital ( Site 2400)

Taipei, , Taiwan

Mackay Memorial Hospital ( Site 2405)

Taipei, , Taiwan

Chang Gung Memorial Hospital - Linkou Branch ( Site 2402)

Taoyuan District, , Taiwan

Ramathibodi Hospital. ( Site 2563)

Ratchthevee, Bangkok, Thailand

Bangkok Hospital Chiangmai ( Site 2560)

Mueang, Chiang Mai, Thailand

Chulalongkorn Hospital ( Site 2561)

Bangkok, , Thailand

Pramongkutklao Hospital ( Site 2564)

Bangkok, , Thailand

Siriraj Hospital ( Site 2562)

Bangkok, , Thailand

Khon Kaen University ( Site 2565)

Khon Kaen, , Thailand

Acibadem Adana Hastanesi ( Site 1904)

Adana, , Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)

Ankara, , Turkey (Türkiye)

Uludag Universitesi Tip Fakultesi ( Site 1914)

Bursa, , Turkey (Türkiye)

Ankara Sehir Hastanesi ( Site 1903)

Cankaya - Ankara, , Turkey (Türkiye)

Trakya Uni. Tip Fakultesi ( Site 1911)

Edirne, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)

Istanbul, , Turkey (Türkiye)

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)

Izmir, , Turkey (Türkiye)

Medical Park Izmir Hospital ( Site 1900)

Izmir, , Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi ( Site 1909)

Kocaeli, , Turkey (Türkiye)

Inonu Universitesi Tip Fakultesi ( Site 1907)

Malatya, , Turkey (Türkiye)

Karadeniz Teknik Universitesi ( Site 1910)

Trabzon, , Turkey (Türkiye)

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

Kryviy Rih, Dnipropetrovsk Oblast, Ukraine

Cherkasy Regional Hospital ( Site 2020)

Cherkasy, , Ukraine

Regional Clinical Onco Dispensary_ State Medical University ( Site 2012)

Chernivtsy, , Ukraine

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

Dnipropetrovsk, , Ukraine

MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009)

Ivano-Frankivsk, , Ukraine

PP PPC Acinus Medical and Diagnostic Centre ( Site 2002)

Kropyvnytskyi, , Ukraine

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

Kyiv, , Ukraine

Kyiv City Clinical Oncological Center ( Site 2014)

Kyiv, , Ukraine

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

Lviv, , Ukraine

MI Odessa Regional Oncological Centre ( Site 2004)

Odesa, , Ukraine

Royal Cornwall Hospital ( Site 1325)

Truro, Cornwall, United Kingdom

The Royal Marsden NHS Foundation Trust. ( Site 1326)

Sutton, Surrey, United Kingdom

Belfast City Hospital ( Site 1302)

Belfast, , United Kingdom

Royal Free NHS Foundation Trust ( Site 1324)

London, , United Kingdom

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

London, , United Kingdom

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

London, , United Kingdom

The Christie NHS Foundation Trust ( Site 1301)

Manchester, , United Kingdom

Mount Vernon Cancer Centre ( Site 1307)

Northwood, , United Kingdom

Royal Wolverhampton Hospitals NHS Trust ( Site 1323)

Wolverhampton, , United Kingdom

Countries

United States; Argentina; Australia; Brazil; Canada; Chile; Colombia; France; Germany; Hungary; Ireland; Italy; Latvia; Mexico; Peru; Poland; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33513313 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

MK-3475-598

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-598

Identifier Type: OTHER

Identifier Source: secondary_id

2016-004364-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3475-598

Identifier Type: -

Identifier Source: org_study_id