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 (MK-3475-937 / 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)

Sponsors

Lead Sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
Brief Summary

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).

Overall Status Recruiting
Start Date May 28, 2019
Completion Date June 30, 2025
Primary Completion Date June 30, 2025
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Recurrence-Free Survival (RFS) Up to ~4 years
Overall Survival (OS) Up to ~6 years
Secondary Outcome
Measure Time Frame
Percentage of Participants who Experience an Adverse Event (AE) Up to ~6 years
Percentage of Participants who Discontinue Study Treatment Due to an AE Up to ~1 year
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score Baseline and time of last patient reported outcome (PRO) assessment (up to ~7 years)
Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score Baseline and time of last PRO assessment (up to ~7 years)
Time to Deterioration (TTD) in the EORTC-QLQ-C30, Combined GHS / QoL Scale Score Time of last PRO assessment (up to ~7 years)
Time to Deterioration (TTD) in the EORTC QLQ-HCC18 Scale Score Time of last PRO assessment (up to ~7 years)
Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score Baseline and time of last PRO assessment (up to ~7 years)
Enrollment 950
Condition
Intervention

Intervention Type: Biological

Intervention Name: Pembrolizumab

Description: IV infusion of Pembrolizumab 200 mg.

Arm Group Label: Pembrolizumab

Intervention Type: Drug

Intervention Name: Placebo

Description: IV infusion of 0.9% normal saline.

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Has a diagnosis of HCC by radiological criteria and/or pathological confirmation.

- Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) confirming complete radiological response ≥4 weeks after complete surgical resection or local ablation. Randomization needs to occur within 12 weeks of the date of surgical resection or local ablation.

- Has no radiologic evidence of disease prior to enrollment.

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.

- Has a Child-Pugh class A liver score (5 to 6 points) within 7 days prior to Cycle 1, Day 1.

- Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1.

- Has controlled hepatitis B (Hep B).

- Has recovered adequately from toxicity and/or complications from the local intervention (surgical resection or local ablation) prior to starting study treatment.

- If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment).

- If undergoing surgical resection, has submitted a tumor tissue sample during Screening.

- Has adequate organ function.

Exclusion Criteria:

- Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years.

- Has had esophageal or gastric variceal bleeding within the last 6 months.

- Has clinically apparent ascites on physical examination.

- Has had clinically diagnosed hepatic encephalopathy in the last 6 months.

- Has received local therapy to liver ablation other than with radiofrequency or microwave ablation.

- Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.

- Has an active infection requiring systemic therapy.

- Has dual active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection at study entry.

- Has a known history of human immunodeficiency virus (HIV) infection.

- Has known active tuberculosis (TB; Bacillus tuberculosis).

- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).

- Has received prior systemic anti-cancer therapy for HCC including investigational agents.

- Is receiving any of the following prohibited concomitant therapies:1) Antineoplastic systemic chemotherapy or biological therapy; 2) Immunotherapy not specified in this protocol; 3) Investigational agents other than pembrolizumab; 4) Radiation therapy; 5) Oncological surgical therapy; or systemic glucocorticoids for any purpose other than to modulate symptoms from an AE that is suspected to have an immunologic etiology.

- Has received a live vaccine within 30 days prior to the first dose of study treatment.

- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to Cycle 1, Day 1.

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1.

- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

- Has an active autoimmune disease that has required systemic treatment in past 2 years.

- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.

- Has had an allogenic tissue/solid organ transplant.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Medical Director Study Director Merck Sharp & Dohme Corp.
Overall Contact

Last Name: Toll Free Number

Phone: 1-888-577-8839

Email: [email protected]

Location
Facility: Status: Contact:
Banner MD Anderson Cancer Center ( Site 0026) | Gilbert, Arizona, 85234, United States Recruiting Study Coordinator 480-256-3425
The University of Arizona Cancer Center - North Campus ( Site 0039) | Tucson, Arizona, 85719, United States Recruiting Study Coordinator 520-626-4175
City of Hope Medical Center ( Site 0027) | Duarte, California, 91010, United States Recruiting Study Coordinator 626-471-9200
Smilow Cancer Hospital at Yale New Haven ( Site 0042) | New Haven, Connecticut, 06510, United States Recruiting Study Coordinator 203-836-4156
Regional Cancer Center ( Site 0054) | Fort Myers, Florida, 33905, United States Recruiting Study Coordinator 239-343-9547
University of Louisville ( Site 0059) | Louisville, Kentucky, 40202, United States Recruiting Study Coordinator 502-629-3355
University Medical Center New Orleans ( Site 0014) | New Orleans, Louisiana, 70112, United States Recruiting Study Coordinator 504-702-3149
Massachusetts General Hospital ( Site 0062) | Boston, Massachusetts, 02114, United States Recruiting Study Coordinator 617-643-0816
Boston Medical Center ( Site 0025) | Boston, Massachusetts, 02118, United States Recruiting Study Coordinator 617-634-1551
Beth Israel Deaconess Medical Ctr. ( Site 0033) | Boston, Massachusetts, 02215, United States Recruiting Study Coordinator 617-667-2100
University of Massachusetts Worcester ( Site 0017) | Worcester, Massachusetts, 01655, United States Recruiting Study Coordinator 774-455-4456
Henry Ford Health System ( Site 0047) | Detroit, Michigan, 48202, United States Recruiting Study Coordinator 313-916-1962
University of New Mexico ( Site 0041) | Albuquerque, New Mexico, 87131, United States Recruiting Study Coordinator 505-925-0405
Stephenson Cancer Center ( Site 0045) | Oklahoma City, Oklahoma, 73104, United States Recruiting Study Coordinator 405-271-8001
Vanderbilt Ingram Cancer Center ( Site 0006) | Nashville, Tennessee, 37232, United States Recruiting Study Coordinator 615-936-8422
Virginia Mason Medical Center ( Site 0028) | Seattle, Washington, 98101, United States Recruiting Study Coordinator 206-223-6193
Hospital Universitario Austral ( Site 0795) | Pilar, Buenos Aires, B1629AHJ, Argentina Recruiting Study Coordinator +542304387049
Hospital Provincial del Centenario ( Site 0794) | Rosario, Santa Fe, S2002KDS, Argentina Recruiting Study Coordinator 543414393511
Hospital Aleman ( Site 0806) | Buenos Aires, C1118AAT, Argentina Recruiting Study Coordinator +541148277000
Hospital Italiano ( Site 0793) | Buenos Aires, C1181ACH, Argentina Recruiting Study Coordinator +5491140502297
Hospital Britanico de Buenos Aires ( Site 0792) | Ciudad Autonoma de Buenos Aires, C1280AEB, Argentina Recruiting Study Coordinator +541143096807
Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802) | Santa Fe, S3000BPJ, Argentina Recruiting Study Coordinator +54342453726254
Royal Prince Alfred Hospital AW ( Site 0225) | Camperdown, New South Wales, 2050, Australia Recruiting Study Coordinator +61295157606
Liverpool Hospital ( Site 0226) | Liverpool, New South Wales, 2170, Australia Recruiting Study Coordinator +61287384085
Princess Alexandra Hospital ( Site 0228) | Woollongabba, Queensland, 4102, Australia Recruiting Study Coordinator +61731762111
Monash Health ( Site 0233) | Clayton, Victoria, 3168, Australia Recruiting Study Coordinator +61395943177
St Vincents Hospital Melbourne ( Site 0227) | Fitzroy, Victoria, 3065, Australia Recruiting Study Coordinator +61392313581
Alfred Health ( Site 0230) | Melbourne, Victoria, 3004, Australia Recruiting Study Coordinator +61390760213
Royal Perth Hospital ( Site 0229) | Perth, Western Australia, 6000, Australia Recruiting Study Coordinator +61892242179
Erasme Hospital ( Site 0376) | Bruxelles, Bruxelles-Capitale, Region De, 1070, Belgium Recruiting Study Coordinator +3225553137
UZ Gent ( Site 0375) | Gent, Oost-Vlaanderen, 9000, Belgium Recruiting Study Coordinator +3293322370
UZ Leuven ( Site 0377) | Leuven, Vlaams-Brabant, 3000, Belgium Recruiting Study Coordinator +3216344218
Nova Scotia Health Authority QEII-HSC ( Site 0208) | Halifax, Nova Scotia, B3H 2Y9, Canada Recruiting Study Coordinator 9024736106
McGill University Health Centre ( Site 0207) | Montreal, Quebec, H4A 3J1, Canada Recruiting Study Coordinator 5149341934x35721
Anhui Provincial Hospital ( Site 0181) | Hefei, Anhui, 230001, China Recruiting Study Coordinator +86055165657629
Beijing Cancer Hospital ( Site 0155) | Beijing, Beijing, 100142, China Recruiting Study Coordinator +8613911501185
Guangdong General Hospital ( Site 0166) | Guangzhou, Guangdong, 510080, China Recruiting Study Coordinator +8613902497476
Southern Medical University Nanfang Hospital ( Site 0172) | Guangzhou, Guangdong, 510515, China Recruiting Study Coordinator +862061641888
Wuhan Union Hospital ( Site 0173) | Wuhan, Hubei, 430022, China Recruiting Study Coordinator +8615007318341
Hubei Cancer Hospital ( Site 0189) | Wuhan, Hubei, 430079, China Recruiting Study Coordinator +862787670138
The Third Xiangya Hospital of Central South University ( Site 0167) | Changsha, Hunan, 410000, China Recruiting Study Coordinator +8615007318341
Hunan Provincial People Hospital ( Site 0192) | Changsha, Hunan, 410005, China Recruiting Study Coordinator +8615974220718
Hunan Cancer Hospital ( Site 0168) | Changsha, Hunan, 410013, China Recruiting Study Coordinator +8613808473128
Fudan University Shanghai Cancer Center ( Site 0161) | Shanghai, Shanghai, 200032, China Recruiting Study Coordinator +8613601678615
Zhongshan Hospital Fudan University ( Site 0193) | Shanghai, Shanghai, 200032, China Recruiting Study Coordinator +862164037181
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174) | Shanghai, Shanghai, 200127, China Recruiting Study Coordinator +8613003175438
Zhongshan Hospital affiliated to Fudan University ( Site 0153) | Shanghai, Shanghai, 210000, China Recruiting Study Coordinator 862164041990
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164) | XI An, Shanxi, 710061, China Recruiting Study Coordinator +8613609195898
West China Hospital of Sichuan University ( Site 0162) | Chengdu, Sichuan, 610041, China Recruiting Study Coordinator +8618980601471
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157) | Urumqi, Xinjiang, 830001, China Recruiting Study Coordinator +8613579209671
Zhejiang Cancer Hospital ( Site 0171) | Hangzhou, Zhejiang, 310022, China Recruiting Study Coordinator +8657188122222
Herlev Hospital ( Site 0421) | Herlev, Hovedstaden, 2730, Denmark Recruiting Study Coordinator +4538682976
Aarhus Universitets hospital ( Site 0420) | Aarhus N, Midtjylland, 8200, Denmark Recruiting Study Coordinator +4578000000
Odense Universitets Hospital ( Site 0422) | Odense C, Syddanmark, 5000, Denmark Recruiting Study Coordinator +4530433566
HUS Hopital Hautepierre ( Site 0445) | Strasbourg, Bas-Rhin, 67098, France Recruiting Study Coordinator +33388127268
Hopital de la Timone ( Site 0442) | Marseille, Bouches-du-Rhone, 13005, France Recruiting Study Coordinator +33491435247
Hopital Haut-Leveque ( Site 0437) | Pessac, Gironde, 33604, France Recruiting Study Coordinator +33557656439
CHU Rangueil ( Site 0441) | Toulouse, Haute-Garonne, 31059, France Recruiting Study Coordinator +33561772527
Hopital Beaujon ( Site 0439) | Clichy, Hauts-de-Seine, 92110, France Recruiting Study Coordinator +33629796967
CHU Montpellier. ( Site 0443) | Montpellier, Herault, 34295, France Recruiting Study Coordinator +33467330137
Hopital Claude Huriez CHRU LILLE ( Site 0440) | Lille, Nord, 59037, France Recruiting Study Coordinator +33320445597
Hopital Paul Brousse ( Site 0447) | Villejuif, Val-de-Marne, 94800, France Recruiting Study Coordinator +33149282923
SLK-Kliniken Heilbronn GmbH ( Site 0460) | Heilbronn, Baden-Wurttemberg, 74078, Germany Recruiting Study Coordinator +4971314928700
Universitaetsklinikum Tuebingen ( Site 0466) | Tuebingen, Baden-Wurttemberg, 72076, Germany Recruiting Study Coordinator +49613177275
Universitaets Klinikum Wuerzburg ( Site 0468) | Wuerzburg, Bayern, 97080, Germany Recruiting Study Coordinator +4993120140170
Universitaetsklinikum Frankfurt ( Site 0467) | Frankfurt, Hessen, 60596, Germany Recruiting Study Coordinator +496963014544
Medizinische Hochschule Hannover ( Site 0458) | Hannover, Niedersachsen, 30625, Germany Recruiting Study Coordinator +495115326779
Universitaetsklinikum Duesseldorf ( Site 0461) | Duesseldorf, Nordrhein-Westfalen, 40225, Germany Recruiting Study Coordinator +492118117820
Universitaetsklinikum Koeln ( Site 0463) | Koeln, Nordrhein-Westfalen, 50937, Germany Recruiting Study Coordinator +492214787334
Staedtisches Klinikum Dresden ( Site 0471) | Dresden, Sachsen, 01067, Germany Recruiting Study Coordinator +493514803741
Universitatsklinikum Carl Gustav Carus ( Site 0459) | Dresden, Sachsen, 01307, Germany Recruiting Study Coordinator +493514584794
Charite - Campus Virchow Klinikum ( Site 0457) | Berlin, 13353, Germany Recruiting Study Coordinator +4930450552001
Universitaetsklinikum Hamburg-Eppendorf ( Site 0469) | Hamburg, 20246, Germany Recruiting Study Coordinator +4915222816347
Pamela Youde Nethersole Eastern Hospital ( Site 0271) | Hong Kong, Hong Kong Recruiting Study Coordinator +85225954183
Prince of Wales Hospital ( Site 0268) | Hong Kong, Hong Kong Recruiting Study Coordinator +85235052166
Queen Mary Hospital ( Site 0267) | Hong Kong, Hong Kong Recruiting Study Coordinator +85222553111
Tuen Mun Hospital ( Site 0272) | Tuen Mun, Hong Kong Recruiting Study Coordinator +85224685086
Bacs-Kiskun Megyei Korhaz ( Site 0483) | Kecskemet, Bacs-Kiskun, 6000, Hungary Recruiting Study Coordinator +3676516719
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482) | Szeged, Csongrad, 6720, Hungary Recruiting Study Coordinator +3662545404
Semmelweis Egyetem ( Site 0480) | Budapest, 1088, Hungary Recruiting Study Coordinator +36206632237
Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481) | Debrecen, 4032, Hungary Recruiting Study Coordinator +36308581463
St Vincent's University Hospital ( Site 0498) | Dublin, D04 T6F4, Ireland Recruiting Study Coordinator +35312214000
Tallaght University Hospital ( Site 0499) | Dublin, D24 NR0A, Ireland Recruiting Study Coordinator +35314144299
Rabin Medical Center ( Site 0520) | Petah Tikva, HaMerkaz, 4941492, Israel Recruiting Study Coordinator +97239378076
Rambam Medical Center ( Site 0524) | Haifa, Heifa, 3109601, Israel Recruiting Study Coordinator +97247771415
Chaim Sheba Medical Center ( Site 0523) | Ramat Gan, Tell Abib, 5262000, Israel Recruiting Study Coordinator +97235307776
Sourasky Medical Center ( Site 0522) | Tel Aviv, Tell Abib, 6423906, Israel Recruiting Study Coordinator +97236973082
Haddassah Medical Organization - Ein Kerem ( Site 0519) | Jerusalem, Yerushalayim, 9112001, Israel Recruiting Study Coordinator +97226777957
Istituto Tumori Giovanni Paolo II ( Site 0543) | Bari, 70124, Italy Recruiting Study Coordinator +390805555353
Policlinico S. Orsola-Malpighi ( Site 0541) | Bologna, 40138, Italy Recruiting Study Coordinator +390512143838
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540) | Milano, 20133, Italy Recruiting Study Coordinator +390223902760
A O U Policlinico di Modena ( Site 0548) | Modena, 41025, Italy Recruiting Study Coordinator +390594223864
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547) | Palermo, 90146, Italy Recruiting Study Coordinator +390916802621
Azienda Ospedaliero Universitaria Pisana ( Site 0546) | Pisa, 56126, Italy Recruiting Study Coordinator +39050992852
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542) | Torino, 10128, Italy Recruiting Study Coordinator +39 3398188822
Ehime University Hospital ( Site 0123) | Toon, Ehime, 791-0295, Japan Recruiting Study Coordinator +81899645111
Kurume University Hospital ( Site 0119) | Kurume, Fukuoka, 830-0011, Japan Recruiting Study Coordinator +81942353311
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102) | Sapporo, Hokkaido, 060-0033, Japan Recruiting Study Coordinator +81112615331
Kanazawa University Hospital ( Site 0111) | Kanazawa, Ishikawa, 920-8641, Japan Recruiting Study Coordinator +81762652000
Kagawa University Hospital ( Site 0121) | Kita-gun, Kagawa, 761-0793, Japan Recruiting Study Coordinator +81878985111
Kagawa Prefectural Central Hospital ( Site 0122) | Takamatsu, Kagawa, 760-8557, Japan Recruiting Study Coordinator +81878113333
Toranomon Hospital Kajigaya ( Site 0109) | Kawasaki, Kanagawa, 213-8587, Japan Recruiting Study Coordinator +81448775111
Yokohama City University Medical Center ( Site 0110) | Yokohama, Kanagawa, 232-0024, Japan Recruiting Study Coordinator +81452615656
Kindai University Hospital ( Site 0116) | Osakasayama, Osaka, 589-8511, Japan Recruiting Study Coordinator +81723660221
Saitama Medical University Hospital ( Site 0104) | Iruma-gun, Saitama, 350-0495, Japan Recruiting Study Coordinator +81492761111
Kyorin University Hospital ( Site 0106) | Mitaka, Tokyo, 181-8611, Japan Recruiting Study Coordinator +81422475511
Musashino Red Cross Hospital ( Site 0107) | Musashino, Tokyo, 180-8610, Japan Recruiting Study Coordinator +81422323111
Chiba University Hospital ( Site 0103) | Chiba, 260-8677, Japan Recruiting Study Coordinator +81432227171
National Hospital Organization Kyushu Medical Center ( Site 0118) | Fukuoka, 810-8563, Japan Recruiting Study Coordinator +81928520700
Hiroshima University Hospital ( Site 0117) | Hiroshima, 734-8551, Japan Recruiting Study Coordinator +81822575555
University Hospital, Kyoto Prefectural University of Medicine ( Site 0112) | Kyoto, 602-8566, Japan Recruiting Study Coordinator +81752515111
Osaka Red Cross Hospital ( Site 0113) | Osaka, 543-8555, Japan Recruiting Study Coordinator +81667745111
Osaka City University Hospital ( Site 0114) | Osaka, 545-8586, Japan Recruiting Study Coordinator +81666452121
Saga-Ken Medical Centre Koseikan ( Site 0120) | Saga, 840-8571, Japan Recruiting Study Coordinator +81952242171
Toranomon Hospital ( Site 0108) | Tokyo, 105-8470, Japan Recruiting Study Coordinator +81335881111
The University of Tokyo Hospital ( Site 0105) | Tokyo, 113-8655, Japan Recruiting Study Coordinator +81338155411
Wakayama Medical University Hospital ( Site 0115) | Wakayama, 641-8510, Japan Recruiting Study Coordinator +81734472300
National Cancer Center ( Site 0314) | Goyang-si, Kyonggi-do, 10408, Korea, Republic of Recruiting Study Coordinator +82319201605
Seoul National University Bundang Hospital ( Site 0313) | Seongnam-si, Kyonggi-do, 13605, Korea, Republic of Recruiting Study Coordinator +82317877009
Seoul National University Hospital ( Site 0312) | Seoul, Seoul-teukbyeolsi [Seoul], 03080, Korea, Republic of Recruiting Study Coordinator 82220722228
Severance Hospital Yonsei University Health System ( Site 0309) | Seoul, Seoul-teukbyeolsi [Seoul], 03722, Korea, Republic of Recruiting Study Coordinator +82222288138
Asan Medical Center ( Site 0310) | Seoul, Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of Recruiting Study Coordinator +82230103915
Samsung Medical Center ( Site 0311) | Seoul, Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of Recruiting Study Coordinator +82234103409
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315) | Seoul, Seoul-teukbyeolsi [Seoul], 06591, Korea, Republic of Recruiting Study Coordinator +82222582077
Hospital Universiti Sains Malaysia ( Site 0295) | Kubang Kerian, Kelantan, 16150, Malaysia Recruiting Study Coordinator +6097676684
Penang Adventist Hospital ( Site 0289) | George Town, Pulau Pinang, 10350, Malaysia Recruiting Study Coordinator +6042227652
Gleneagles Penang ( Site 0290) | Penang, Pulau Pinang, 10050, Malaysia Recruiting Study Coordinator +6042285760
Sarawak General Hospital ( Site 0293) | Kuching, Sarawak, 93586, Malaysia Recruiting Study Coordinator +6082276666
Institut Kanser Negara - National Cancer Institute ( Site 0294) | Putrajaya Wilayah Persekutuan, Wilayah Persekutuan Putrajaya, 62250, Malaysia Recruiting Study Coordinator +60388925555
Christchurch Hospital ( Site 0247) | Christchurch, Canterbury, 8011, New Zealand Recruiting Study Coordinator +6433640922
Auckland City Hospital ( Site 0246) | Auckland, 1023, New Zealand Recruiting Study Coordinator +6493074949
Oslo Universitetssykehus HF. Ulleval ( Site 0433) | Oslo, 0450, Norway Recruiting Study Coordinator +4723026600
Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607) | Szklarska Poreba, Dolnoslaskie, 58-580, Poland Recruiting Study Coordinator +48757547148
MTZ Clinical Research Sp. z o. o. ( Site 0608) | Warsaw, Mazowieckie, 02-106, Poland Recruiting Study Coordinator +48661234384
Copernicus PL Sp. z o.o. ( Site 0603) | Gdansk, Pomorskie, 80-219, Poland Recruiting Study Coordinator +48505993747
ID Clinic ( Site 0619) | Myslowice, Slaskie, 41-400, Poland Recruiting Study Coordinator +48502338571
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606) | Olsztyn, Warminsko-mazurskie, 10-228, Poland Recruiting Study Coordinator +48698826497
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604) | Koszalin, Zachodniopomorskie, 75-581, Poland Recruiting Study Coordinator +48502204953
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648) | Krasnoyarsk, Krasnoyarskiy Kray, 660133, Russian Federation Recruiting Study Coordinator +79135349316
Blokhin National Medical Oncology ( Site 0645) | Moscow, Moskva, 115478, Russian Federation Recruiting Study Coordinator +79031990755
City Clinical Hospital 1 na. NI. Pirogov ( Site 0662) | Moscow, Moskva, 119049, Russian Federation Recruiting Study Coordinator +79031991945
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661) | Moscow, Moskva, 119881, Russian Federation Recruiting Study Coordinator +79165134577
National Medical Research Radiological Centre ( Site 0660) | Moscow, Moskva, 125284, Russian Federation Recruiting Study Coordinator +79039686637
Samara Regional Clinical Oncology Center ( Site 0656) | Samara, Samarskaya Oblast', 443031, Russian Federation Recruiting Study Coordinator +78469947650
Road Hospital JSC Russian railways ( Site 0649) | Saint Petersburg, Sankt-Peterburg, 195271, Russian Federation Recruiting Study Coordinator +79052154918
City Clinical Oncology Center ( Site 0646) | Saint Petersburg, Sankt-Peterburg, 198255, Russian Federation Recruiting Study Coordinator +79111019156
Tomsk Scientific Research Institute of Oncology ( Site 0657) | Tomsk, Tomskaya Oblast', 634028, Russian Federation Recruiting Study Coordinator +79039132574
Complejo Hospitalario Universitario de Santiago ( Site 0668) | Santiago de Compostela, A Coruna [La Coruna], 15706, Spain Recruiting Study Coordinator +34981951367
Hospital Central de Asturias ( Site 0667) | Oviedo, Asturias, 33011, Spain Recruiting Study Coordinator +3498510800039501
Hospital Universitari Vall d Hebron ( Site 0674) | Barcelona, Barcelona [Barcelona], 08035, Spain Recruiting Study Coordinator +34932746140
Hospital Universitario de Donostia ( Site 0671) | San Sebastian, Gipuzkoa, 20014, Spain Recruiting Study Coordinator +349430070003662
Hospital Universitario Puerta de Hierro ( Site 0678) | Majadahonda, Madrid, 28222, Spain Recruiting Study Coordinator +34911917889
Hospital General Universitario Gregorio Maranon ( Site 0676) | Madrid, 28007, Spain Recruiting Study Coordinator +34915868308
Hospital Ramon y Cajal ( Site 0673) | Madrid, 28034, Spain Recruiting Study Coordinator +34913368589
Hospital Universitario La Paz ( Site 0677) | Madrid, 28046, Spain Recruiting Study Coordinator +34912071876
Hospital Universitario Virgen del Rocio ( Site 0670) | Sevilla, 41013, Spain Recruiting Study Coordinator +34955012065
Skane University Hospital ( Site 0692) | Malmo, Skane Lan [se-12], 205 02, Sweden Recruiting Study Coordinator +46768936655
Karolinska Universitetssjukhuset, Huddinge ( Site 0689) | Stockholm, Stockholms Lan [se-01], 141 86, Sweden Recruiting Study Coordinator +6858587122
Norrlands Universitetssjukhus ( Site 0687) | Umea, Vasterbottens Lan [se-24], 901 85, Sweden Recruiting Study Coordinator +46907851993
Sahlgrenska Universitetssjukhuset ( Site 0691) | Goteborg, Vastra Gotalands Lan [se-14], 413 46, Sweden Recruiting Study Coordinator +46705259301
Universitaetsspital Basel ( Site 0709) | Basel, Basel-Stadt, 4031, Switzerland Recruiting Study Coordinator +41612655174
Universitaetsspital Bern ( Site 0710) | Bern, Berne, 3010, Switzerland Recruiting Study Coordinator +41316328026
Kantonsspital St. Gallen ( Site 0708) | St. Gallen, Sankt Gallen, 9007, Switzerland Recruiting Study Coordinator +417474942767
CHUV Hospital Lausanne ( Site 0712) | Lausanne, Vaud, 1011, Switzerland Recruiting Study Coordinator +41795567902
Hopitaux Universitaires de Geneve HUG ( Site 0711) | Geneve, 1211, Switzerland Recruiting Study Coordinator +41223729861
Universitaetsspital Zurich ( Site 0713) | Zurich, 8091, Switzerland Recruiting Study Coordinator +41442551111
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335) | Kaohsiung, 833, Taiwan Recruiting Study Coordinator +88677317123
China Medical University Hospital ( Site 0333) | Taichung, 404, Taiwan Recruiting Study Coordinator +8864220521211761
National Cheng Kung University Hospital ( Site 0334) | Tainan, 704, Taiwan Recruiting Study Coordinator 886623535353587
National Taiwan University Hospital ( Site 0330) | Taipei, 100, Taiwan Recruiting Study Coordinator +886223123456
Taipei Veterans General Hospital ( Site 0331) | Taipei, 112, Taiwan Recruiting Study Coordinator +886228712121
Chang Gung Medical Foundation. Linkou ( Site 0332) | Taoyuan, 333, Taiwan Recruiting Study Coordinator +88633281200
Ramathibodi Hospital. ( Site 0352) | Bangkok, Krung Thep Maha Nakhon, 10400, Thailand Recruiting Study Coordinator +66909741417
Siriraj Hospital ( Site 0351) | Bangkok, Krung Thep Maha Nakhon, 10700, Thailand Recruiting Study Coordinator +6624194488
Maharaj Nakorn Chiangmai Hospital ( Site 0353) | Chiang Mai, 50200, Thailand Recruiting Study Coordinator +6653935480
Srinagarind Hospital ( Site 0354) | Khon Kaen, 40002, Thailand Recruiting Study Coordinator +6643366568
Namik Kemal Universitesi Tip Fakultesi ( Site 0738) | Tekirdag, Tekirdas, 59100, Turkey Recruiting Study Coordinator +905059400839
Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733) | Adana, 01120, Turkey Recruiting Study Coordinator +905056166338
Ankara Sehir Hastanesi ( Site 0731) | Ankara, 06800, Turkey Recruiting Study Coordinator +905555306271
Adnan Menderes University Medical Faculty ( Site 0737) | Aydin, 09010, Turkey Recruiting Study Coordinator +905423231635
Bezmialem Vakif University School of Medicine ( Site 0732) | Istanbul, 34093, Turkey Recruiting Study Coordinator +905055618756
Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi ( Site 0730) | Istanbul, 34732, Turkey Recruiting Study Coordinator +905063509061
Dokuz Eylul Universitesi ( Site 0740) | Izmir, 35340, Turkey Recruiting Study Coordinator +90506481389
Konya Necmettin Erbakan University Medical Faculty ( Site 0736) | Konya, 42080, Turkey Recruiting Study Coordinator +905322679838
Inonu University Faculty of Medicine ( Site 0729) | Malatya, 44280, Turkey Recruiting Study Coordinator +905385003562
VM Medical Park Hastanesi ( Site 0739) | Mersin, 33440, Turkey Recruiting Study Coordinator +905354544590
Regional Clinical Onco Dispensary_ State Medical University ( Site 0782) | Chernivtsi, Chernivetska Oblast, 58000, Ukraine Recruiting Study Coordinator +380372547650
Regional Oncology Center of Kharkiv ( Site 0777) | Kharkiv, Kharkivska Oblast, 61000, Ukraine Recruiting Study Coordinator +380573151173
National Cancer Institute of the MoH of Ukraine ( Site 0779) | Kyiv, Kyivska Oblast, 03022, Ukraine Recruiting Study Coordinator +380509095151
Shalimov s NI of Surgery and Transplantation ( Site 0781) | Kyiv, Kyivska Oblast, 03126, Ukraine Recruiting Study Coordinator +380939720596
MI Odessa Regional Oncological Centre ( Site 0776) | Odesa, Odeska Oblast, 65055, Ukraine Recruiting Study Coordinator +380504261911
CI City Clinical Hospital # 3 ( Site 0783) | Zaporizhzhia, Zaporizka Oblast, 69032, Ukraine Recruiting Study Coordinator +380612131541
Cambridge University Hospitals NHS Trust ( Site 0755) | Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom Recruiting Study Coordinator +441223769310
Weston Park Hospital ( Site 0753) | Sheffield, England, S10 2SJ, United Kingdom Recruiting Study Coordinator +441142265000
Kings College Hospital NHS Foundation Trust ( Site 0758) | London, London, City Of, SE5 9RS, United Kingdom Recruiting Study Coordinator +442032997615
Nottingham University Hospitals NHS Trust ( Site 0756) | Nottingham, Nottinghamshire, NG5 1PB, United Kingdom Recruiting Study Coordinator +4402381204202
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757) | Birkenhead, CH63 4JY, United Kingdom Recruiting Study Coordinator +441515665716
University Hospital Coventry and Warwickshire NHS Trust ( Site 0754) | Coventry, CV3 2DX, United Kingdom Recruiting Study Coordinator +441142265000
Leeds Teaching Hospitals NHS Trust ( Site 0751) | Leeds, LS9 7TF, United Kingdom Recruiting Study Coordinator +441132433144
Location Countries

Argentina

Australia

Belgium

Canada

China

Denmark

France

Germany

Hong Kong

Hungary

Ireland

Israel

Italy

Japan

Korea, Republic of

Malaysia

New Zealand

Norway

Poland

Russian Federation

Spain

Sweden

Switzerland

Taiwan

Thailand

Turkey

Ukraine

United Kingdom

United States

Verification Date

August 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Pembrolizumab

Type: Experimental

Description: Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.

Label: Placebo

Type: Placebo Comparator

Description: Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov