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.
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
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There are 181 Locations for this study
Phoenix Arizona, 85054, United States
Burbank California, 91505, United States
Monterey California, 93940, United States
Santa Monica California, 90404, United States
Orlando Florida, 32804, United States
Paducah Kentucky, 42003, United States
Scarborough Maine, 04074, United States
Boston Massachusetts, 02118, United States
Burlington Massachusetts, 01805, United States
Teaneck New Jersey, 07666, United States
New York New York, 10029, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43219, United States
Portland Oregon, 97213, United States
Greenville South Carolina, 29615, United States
Chattanooga Tennessee, 37403, United States
Knoxville Tennessee, 37909, United States
Arlington Texas, 76014, United States
Dallas Texas, 75203, United States
Flower Mound Texas, 75028, United States
Longview Texas, 75601, United States
Vancouver Washington, 98684, United States
Yakima Washington, 98902, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
Viedma Rio Negro, R8500, Argentina
Rosario Santa Fe, S2000, Argentina
Buenos Aires , C1118, Argentina
Cordoba , X5016, Argentina
La Rioja , F5300, Argentina
Rosario , S2000, Argentina
Rosario , S2000, Argentina
Tucuman , T4000, Argentina
South Brisbane Queensland, 4101, Australia
Perth Western Australia, 6150, Australia
Camperdown , 2050, Australia
Douglas , 4814, Australia
Fitzroy , 3065, Australia
Recife Pernambuco, 50070, Brazil
Santa Maria Rio Grande Do Sul, 97015, Brazil
Porto Alegre RS, 91350, Brazil
Sao Paulo SP, 01246, Brazil
Sao Paulo SP, 01323, Brazil
Sao Paulo SP, 04024, Brazil
Barretos , 14784, Brazil
Florianopolis , 88034, Brazil
Sao Paulo , 04039, Brazil
Calgary Alberta, T2N 4, Canada
Winnipeg Manitoba, R3E 0, Canada
Chicoutimi Quebec, G7H 5, Canada
Greenfield Park Quebec, J4V 2, Canada
Levis Quebec, G6V 3, Canada
Montreal Quebec, H3T 1, Canada
St-Jerome Quebec, J7Z 5, Canada
Talca El Maule, 34655, Chile
Santiago , 75000, Chile
Santiago , 83300, Chile
Santiago , 83804, Chile
Vina del Mar , 25200, Chile
Medellin Antioquia, 05003, Colombia
Bogota , 11022, Colombia
Bogota , 11031, Colombia
Monteria , 23000, Colombia
Pasto , 52000, Colombia
Marseille Cedex 20, 13015, France
Bordeaux , 33076, France
Brest , 29200, France
Creteil , 94010, France
Le Mans , 72037, France
Lille , 59037, France
Paris , 75020, France
Strasbourg , 67091, France
Toulouse , 31059, France
Berlin , 13125, Germany
Berlin , 13585, Germany
Berlin , 14165, Germany
Gera , 07548, Germany
Grosshansdorf , 22927, Germany
Heidelberg , 69126, Germany
Leipzig , 04103, Germany
Luebeck , 23538, Germany
Budapest , 1121, Hungary
Budapest , 1122, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Farkasgyepu , 8582, Hungary
Gyor , 9024, Hungary
Gyula , 5700, Hungary
Szekesfehervar , 8000, Hungary
Szolnok , 5000, Hungary
Dublin , D09 V, Ireland
Dublin , Dubli, Ireland
Limerick , V94 F, Ireland
San Giovanni Rotondo (FG) Foggia, 71013, Italy
Rozzano Milano, 20089, Italy
Legnago Verona, 37045, Italy
Brescia , 25123, Italy
Milano , 20141, Italy
Monza , 20900, Italy
Napoli , 80131, Italy
Perugia , 06132, Italy
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Riga , 1002, Latvia
Riga , 1079, Latvia
Guadalajara Jalisco, 44200, Mexico
Monterrey N.l., 64710, Mexico
Merida Yucatan, 97070, Mexico
Ciudad de Mexico , 03310, Mexico
Mexico City , 14050, Mexico
Puebla , 72530, Mexico
La Victoria Lima, 15033, Peru
Arequipa , 04000, Peru
Arequipa , 04000, Peru
Lima , 15036, Peru
Lima , 15102, Peru
Trujillo , 13007, Peru
Wroclaw Dolnoslaskie, 53-41, Poland
Koszalin Zachodniopomorskie, 75-58, Poland
Brzeziny , 95-06, Poland
Bydgoszcz , 85-79, Poland
Konin , 62-50, Poland
Olsztyn , 10-35, Poland
Poznan , 60-69, Poland
Warszawa , 02-78, Poland
Bloemfontein Free State, 9301, South Africa
Alberton Gauteng, 1448, South Africa
Pretoria Gauteng, 0081, South Africa
Cape Town , 7405, South Africa
Cape Town , 8000, South Africa
Durban , 4001, South Africa
Johannesburg , 2193, South Africa
Johannesburg , 2196, South Africa
Kraaifontein , 7570, South Africa
Badalona Barcelona, 08916, Spain
Hospitalet de Llobregat Barcelona, 08908, Spain
Caceres Extremadura, 10003, Spain
Las Palmas de Gran Canaria Gran Canaria, 35001, Spain
Barcelona , 08035, Spain
Madrid , 28040, Spain
Sevilla , 41013, Spain
Changhua , 50006, Taiwan
Kaohsiung , 833, Taiwan
Taichung , 404, Taiwan
Tainan , 70457, Taiwan
Taipei , 10048, Taiwan
Taipei , 104, Taiwan
Taoyuan , 33305, Taiwan
Ratchthevee Bangkok, 10400, Thailand
Mueang Chiang Mai, 50000, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Khon Kaen , 40002, Thailand
Adana , 01130, Turkey
Ankara , 06100, Turkey
Bursa , 16059, Turkey
Cankaya - Ankara , 06490, Turkey
Edirne , 22030, Turkey
Istanbul , 34098, Turkey
Istanbul , 34899, Turkey
Izmir , 35100, Turkey
Izmir , 35575, Turkey
Kocaeli , 41380, Turkey
Malatya , 44280, Turkey
Trabzon , 61080, Turkey
Kryviy Rih Dnipropetrovsk Region, 50048, Ukraine
Cherkasy , 18009, Ukraine
Chernivtsy , 58013, Ukraine
Dnipropetrovsk , 49102, Ukraine
Ivano-Frankivsk , 76018, Ukraine
Kropyvnytskyi , 25006, Ukraine
Kyiv , 03002, Ukraine
Kyiv , 03115, Ukraine
Lviv , 79031, Ukraine
Odesa , 65055, Ukraine
Truro Cornwall, TR1 3, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Belfast , BT9 7, United Kingdom
London , NW3 2, United Kingdom
London , SW17 , United Kingdom
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Northwood , HA6 2, United Kingdom
Wolverhampton , WV10 , United Kingdom
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