A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)
A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)
This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).
Inclusion Criteria:
Exclusion Criteria:
Tucson, Arizona 85719, United States
Lake Success, New York 11042, United States
Buenos Aires, Buenos Aires F.D. C1096AAS, Argentina
Santa Fe, S3000BPJ, Argentina
Woollongabba, Queensland 4102, Australia
Itajaí, Santa Catarina 88301-220, Brazil
Beijing, Beijing Municipality 100021, China
Shanghai, Shanghai Municipality 200127, China
Shanghai, Shanghai Municipality 210000, China
Kecskemét, Bács-Kiskun county 6000, Hungary
Kaposvár, Somogy County 7400, Hungary
Modena, Abruzzo 41025, Italy
Kita-gun, Kagawa-ken 761-0793, Japan
Iruma-gun, Saitama 350-0495, Japan
Putrajaya Wilayah Persekutuan, Putrajaya 62250, Malaysia
Szklarska Poręba, Lower Silesian Voivodeship 58-580, Poland
Lublin, Lublin Voivodeship 20-081, Poland
Olsztyn, Warmian-Masurian Voivodeship 10-228, Poland
Koszalin, West Pomeranian Voivodeship 75-581, Poland
Krasnoyarsk, Krasnoyarsk Krai 660133, Russia
Nizhny Novgorod, Nizhny Novgorod Oblast 603109, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Santiago de Compostela, La Coruna 15706, Spain
Bern, Canton of Aargau 3010, Switzerland
Lausanne, Canton of Vaud 1011, Switzerland
Istanbul, 34722, Turkey (Türkiye)
Chernivtsi, Chernivetska Oblast 58000, Ukraine
Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
Glasgow, Glasgow City G12 0YN, United Kingdom
London, London, City of SE5 9RS, United Kingdom
Birkenhead, Wirral CH63 4JY, United Kingdom
Coventry, CV3 2DX, United Kingdom