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)
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.
Inclusion Criteria:
Exclusion Criteria:
Paducah, Kentucky 42003, United States
Portland, Oregon 97213, United States
Chattanooga, Tennessee 37403, United States
Yakima, Washington 98902, United States
Milwaukee, Wisconsin 53226, United States
Viedma, Río Negro Province R8500ACE, Argentina
Recife, Pernambuco 50070-550, Brazil
Santa Maria, Rio Grande do Sul 97015-513, Brazil
Koszalin, West Pomeranian Voivodeship 75-581, Poland
Las Palmas de Gran Canaria, Gran Canaria 35001, Spain
Ratchthevee, Bangkok 10400, Thailand
Mueang, Chiang Mai 50000, Thailand
Cankaya - Ankara, 06490, Turkey (Türkiye)
Istanbul, 34899, Turkey (Türkiye)
Kryviy Rih, Dnipropetrovsk Oblast 50048, Ukraine
Chernivtsy, 58013, Ukraine
Dnipropetrovsk, 49102, Ukraine