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)
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)
Sponsors
Source
Merck Sharp & Dohme Corp.
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
No
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
2019-05-28
Completion Date
2025-06-30
Primary Completion Date
2025-06-30
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 ~5 years) |
Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score |
Baseline and time of last PRO assessment (up to ~5 years) |
Time to Deterioration (TTD) in the EORTC-QLQ-C30, Combined GHS / QoL Scale Score |
Time of last PRO assessment (up to ~5 years) |
Time to Deterioration (TTD) in the EORTC QLQ-HCC18 Scale Score |
Time of last PRO assessment (up to ~5 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 ~5 years) |
Enrollment
950
Condition
Intervention
Intervention Type
Biological
Intervention Name
Description
IV infusion of Pembrolizumab 200 mg.
Arm Group Label
Pembrolizumab
Other Name
KEYTRUDA®
MK-3475
Intervention Type
Drug
Intervention Name
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 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.
- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study treatment.
- 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
Location
Facility |
Status |
Contact |
The University of Arizona Cancer Center - North Campus ( Site 0039) Tucson Arizona 85719 United States |
Recruiting |
Last Name: Study Coordinator Phone: 520-626-4175 |
City of Hope Medical Center ( Site 0027) Duarte California 91010 United States |
Recruiting |
Last Name: Study Coordinator Phone: 626-471-9200 |
Smilow Cancer Hospital at Yale New Haven ( Site 0042) New Haven Connecticut 06510 United States |
Recruiting |
Last Name: Study Coordinator Phone: 203-836-4156 |
Regional Cancer Center ( Site 0054) Fort Myers Florida 33905 United States |
Recruiting |
Last Name: Study Coordinator Phone: 239-343-9547 |
University Medical Center New Orleans ( Site 0014) New Orleans Louisiana 70112 United States |
Recruiting |
Last Name: Study Coordinator Phone: 504-702-3149 |
Boston Medical Center ( Site 0025) Boston Massachusetts 02118 United States |
Recruiting |
Last Name: Study Coordinator Phone: 617-634-1551 |
University of Massachusetts Worcester ( Site 0017) Worcester Massachusetts 01655 United States |
Recruiting |
Last Name: Study Coordinator Phone: 774-455-4456 |
Henry Ford Health System ( Site 0047) Detroit Michigan 48202 United States |
Recruiting |
Last Name: Study Coordinator Phone: 313-916-1962 |
University of New Mexico ( Site 0041) Albuquerque New Mexico 87131 United States |
Recruiting |
Last Name: Study Coordinator Phone: 505-925-0405 |
Stephenson Cancer Center ( Site 0045) Oklahoma City Oklahoma 73104 United States |
Recruiting |
Last Name: Study Coordinator Phone: 405-271-8001 |
Vanderbilt Ingram Cancer Center ( Site 0006) Nashville Tennessee 37232 United States |
Recruiting |
Last Name: Study Coordinator Phone: 615-936-8422 |
Virginia Mason Medical Center ( Site 0028) Seattle Washington 98101 United States |
Recruiting |
Last Name: Study Coordinator Phone: 206-223-6193 |
Hospital Britanico de Buenos Aires ( Site 0792) Ciudad Autonoma de Buenos Aires Buenos Aires C1280AEB Argentina |
Recruiting |
Last Name: Study Coordinator Phone: +541143096807 |
Hospital Universitario Austral ( Site 0795) Pilar Buenos Aires B1629ODT Argentina |
Recruiting |
Last Name: Study Coordinator Phone: +542304482422 |
Hospital Aleman ( Site 0806) Buenos Aires C1118AAT Argentina |
Recruiting |
Last Name: Study Coordinator Phone: +541148277000 |
Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802) Santa Fe S3000BPJ Argentina |
Recruiting |
Last Name: Study Coordinator Phone: +54342453726254 |
Monash Health ( Site 0233) Clayton Victoria 3168 Australia |
Recruiting |
Last Name: Study Coordinator Phone: +61395943177 |
Alfred Health ( Site 0230) Melbourne Victoria 3004 Australia |
Recruiting |
Last Name: Study Coordinator Phone: +61390760213 |
St Vincents Hospital Melbourne ( Site 0227) Melbourne Victoria 3065 Australia |
Recruiting |
Last Name: Study Coordinator Phone: +61392313581 |
Royal Perth Hospital ( Site 0229) Perth Western Australia 6000 Australia |
Recruiting |
Last Name: Study Coordinator Phone: +61892242179 |
Royal Prince Alfred Hospital AW ( Site 0225) Camperdown 2050 Australia |
Recruiting |
Last Name: Study Coordinator Phone: +61295157606 |
Princess Alexandra Hospital ( Site 0228) Woollongabba 4102 Australia |
Recruiting |
Last Name: Study Coordinator Phone: +61731762111 |
UZ Gent ( Site 0375) Gent 9000 Belgium |
Recruiting |
Last Name: Study Coordinator Phone: +3293322370 |
UZ Leuven ( Site 0377) Leuven 3000 Belgium |
Recruiting |
Last Name: Study Coordinator Phone: +3216344218 |
Nova Scotia Health Authority QEII-HSC ( Site 0208) Halifax Nova Scotia B3H 2Y9 Canada |
Recruiting |
Last Name: Study Coordinator Phone: 9024736106 |
McGill University Health Centre ( Site 0207) Montreal Quebec H4A 3J1 Canada |
Recruiting |
Last Name: Study Coordinator Phone: 5149341934x35721 |
Southern Medical University Nanfang Hospital ( Site 0172) Guangzhou Guangdong 510515 China |
Recruiting |
Last Name: Study Coordinator Phone: +862061641888 |
Hubei Cancer Hospital ( Site 0189) Wuhan Hubei 430079 China |
Recruiting |
Last Name: Study Coordinator Phone: +862787670138 |
The Third Xiangya Hospital of Central South University ( Site 0167) Changsha Hunan 410000 China |
Recruiting |
Last Name: Study Coordinator Phone: +8615007318341 |
Zhongshan Hospital affiliated to Fudan University ( Site 0153) Shanghai Shanghai 200032 China |
Recruiting |
Last Name: Study Coordinator Phone: 862164041990 |
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157) Urumqi Xinjiang 830001 China |
Recruiting |
Last Name: Study Coordinator Phone: +8613579209671 |
Zhongshan Hospital Fudan University ( Site 0193) Shanghai 200032 China |
Recruiting |
Last Name: Study Coordinator Phone: +862164037181 |
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174) Shanghai 200127 China |
Recruiting |
Last Name: Study Coordinator Phone: +8613003175438 |
Aarhus Universitets hospital ( Site 0420) Aarhus N 8200 Denmark |
Recruiting |
Last Name: Study Coordinator Phone: +4578000000 |
Herlev Hospital ( Site 0421) Herlev 2730 Denmark |
Recruiting |
Last Name: Study Coordinator Phone: +4538682976 |
Odense Universitets Hospital ( Site 0422) Odense C 5000 Denmark |
Recruiting |
Last Name: Study Coordinator Phone: +4530433566 |
Hopital Beaujon ( Site 0439) Clichy 92110 France |
Recruiting |
Last Name: Study Coordinator Phone: +33629796967 |
Hopital Claude Huriez CHRU LILLE ( Site 0440) Lille 59037 France |
Recruiting |
Last Name: Study Coordinator Phone: +33320445597 |
Hopital de la Timone ( Site 0442) Marseille 13005 France |
Recruiting |
Last Name: Study Coordinator Phone: +33491435247 |
CHU Montpellier. ( Site 0443) Montpellier 34295 France |
Recruiting |
Last Name: Study Coordinator Phone: +33467330137 |
Hopital Haut-Leveque ( Site 0437) Pessac 33604 France |
Recruiting |
Last Name: Study Coordinator Phone: +33557656439 |
HUS Hopital Hautepierre ( Site 0445) Strasbourg 67098 France |
Recruiting |
Last Name: Study Coordinator Phone: +33388127268 |
CHU Rangueil ( Site 0441) Toulouse 31059 France |
Recruiting |
Last Name: Study Coordinator Phone: +33561772527 |
Hopital Paul Brousse ( Site 0447) Villejuif 94800 France |
Recruiting |
Last Name: Study Coordinator Phone: +33149282923 |
Charite - Campus Virchow Klinikum ( Site 0457) Berlin 13353 Germany |
Recruiting |
Last Name: Study Coordinator Phone: +4930450552001 |
Universitatsklinikum Carl Gustav Carus ( Site 0459) Dresden 01307 Germany |
Recruiting |
Last Name: Study Coordinator Phone: +493514584794 |
Universitaetsklinikum Duesseldorf ( Site 0461) Duesseldorf 40225 Germany |
Recruiting |
Last Name: Study Coordinator Phone: +492118117820 |
SLK-Kliniken Heilbronn GmbH ( Site 0460) Heilbronn 74078 Germany |
Recruiting |
Last Name: Study Coordinator Phone: +4971314928700 |
Universitaetsklinikum Koeln ( Site 0463) Koeln 50937 Germany |
Recruiting |
Last Name: Study Coordinator Phone: +492214787334 |
Universitaetsklinikum Tuebingen ( Site 0466) Tuebingen 72076 Germany |
Recruiting |
Last Name: Study Coordinator Phone: +49613177275 |
Universitaets Klinikum Wuerzburg ( Site 0468) Wuerzburg 97080 Germany |
Recruiting |
Last Name: Study Coordinator Phone: +4993120140170 |
Pamela Youde Nethersole Eastern Hospital ( Site 0271) Hong Kong Hong Kong |
Recruiting |
Last Name: Study Coordinator Phone: +85225954183 |
Prince of Wales Hospital ( Site 0268) Hong Kong Hong Kong |
Recruiting |
Last Name: Study Coordinator Phone: +85235052166 |
Queen Mary Hospital ( Site 0267) Hong Kong Hong Kong |
Recruiting |
Last Name: Study Coordinator Phone: +85222553111 |
Tuen Mun Hospital ( Site 0272) Tuen Mun Hong Kong |
Recruiting |
Last Name: Study Coordinator Phone: +85224685086 |
Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481) Debrecen 4032 Hungary |
Recruiting |
Last Name: Study Coordinator Phone: +36308581463 |
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482) Szeged 6720 Hungary |
Recruiting |
Last Name: Study Coordinator Phone: +3662545404 |
St Vincent's University Hospital ( Site 0498) Dublin D04 T6F4 Ireland |
Recruiting |
Last Name: Study Coordinator Phone: +35312214000 |
Haddassah Medical Organization - Ein Kerem ( Site 0519) Jerusalem 9112001 Israel |
Recruiting |
Last Name: Study Coordinator Phone: +97226777957 |
Rabin Medical Center ( Site 0520) Petah Tikva 4941492 Israel |
Recruiting |
Last Name: Study Coordinator Phone: +97239378076 |
Chaim Sheba Medical Center ( Site 0523) Ramat Gan 5262000 Israel |
Recruiting |
Last Name: Study Coordinator Phone: +97235307776 |
Sourasky Medical Center ( Site 0522) Tel Aviv 6423906 Israel |
Recruiting |
Last Name: Study Coordinator Phone: +97236973082 |
Istituto Tumori Giovanni Paolo II ( Site 0543) Bari 70124 Italy |
Recruiting |
Last Name: Study Coordinator Phone: +390805555353 |
Policlinico S. Orsola-Malpighi ( Site 0541) Bologna 40138 Italy |
Recruiting |
Last Name: Study Coordinator Phone: +390512143838 |
A O U Policlinico di Modena ( Site 0548) Modena 41025 Italy |
Recruiting |
Last Name: Study Coordinator Phone: +390594223864 |
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547) Palermo 90146 Italy |
Recruiting |
Last Name: Study Coordinator Phone: +390916802621 |
Azienda Ospedaliero Universitaria Pisana ( Site 0546) Pisa 56126 Italy |
Recruiting |
Last Name: Study Coordinator Phone: +39050992852 |
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542) Torino 10128 Italy |
Recruiting |
Last Name: Study Coordinator Phone: +39 3398188822 |
Ehime University Hospital ( Site 0123) Toon Ehime 791-0295 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81899645111 |
Kurume University Hospital ( Site 0119) Kurume Fukuoka 830-0011 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81942353311 |
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102) Sapporo Hokkaido 060-0033 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81112615331 |
Kanazawa University Hospital ( Site 0111) Kanazawa Ishikawa 920-8641 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81762652000 |
Kagawa University Hospital ( Site 0121) Kita-gun Kagawa 761-0793 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81878985111 |
Kagawa Prefectural Central Hospital ( Site 0122) Takamatsu Kagawa 760-8557 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81878113333 |
Toranomon Hospital Kajigaya ( Site 0109) Kawasaki Kanagawa 213-8587 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81448775111 |
Yokohama City University Medical Center ( Site 0110) Yokohama Kanagawa 232-0024 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81452615656 |
Kindai University Hospital ( Site 0116) Osakasayama Osaka 589-8511 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81723660221 |
Saitama Medical University Hospital ( Site 0104) Iruma-gun Saitama 350-0495 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81492761111 |
Musashino Red Cross Hospital ( Site 0107) Musashino Tokyo 180-8610 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81422323111 |
Chiba University Hospital ( Site 0103) Chiba 260-8677 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81432227171 |
National Hospital Organization Kyushu Medical Center ( Site 0118) Fukuoka 810-8563 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81928520700 |
Hiroshima University Hospital ( Site 0117) Hiroshima 734-8551 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81822575555 |
University Hospital, Kyoto Prefectural University of Medicine ( Site 0112) Kyoto 602-8566 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81752515111 |
Osaka Red Cross Hospital ( Site 0113) Osaka 543-8555 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81667745111 |
Osaka City University Hospital ( Site 0114) Osaka 545-8586 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81666452121 |
Saga-Ken Medical Centre Koseikan ( Site 0120) Saga 840-8571 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81952242171 |
Toranomon Hospital ( Site 0108) Tokyo 105-8470 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81335881111 |
The University of Tokyo Hospital ( Site 0105) Tokyo 113-8655 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81338155411 |
Wakayama Medical University Hospital ( Site 0115) Wakayama 641-8510 Japan |
Recruiting |
Last Name: Study Coordinator Phone: +81734472300 |
National Cancer Center ( Site 0314) Goyang-si Gyeonggi-do 10408 Korea, Republic of |
Recruiting |
Last Name: Study Coordinator Phone: +82319201605 |
Seoul National University Bundang Hospital ( Site 0313) Seongnam-si Gyeonggi-do 13605 Korea, Republic of |
Recruiting |
Last Name: Study Coordinator Phone: +82317877009 |
Seoul National University Hospital ( Site 0312) Seoul 03080 Korea, Republic of |
Recruiting |
Last Name: Study Coordinator Phone: 82220722228 |
Severance Hospital Yonsei University Health System ( Site 0309) Seoul 03722 Korea, Republic of |
Recruiting |
Last Name: Study Coordinator Phone: +82222288138 |
Asan Medical Center ( Site 0310) Seoul 05505 Korea, Republic of |
Recruiting |
Last Name: Study Coordinator Phone: +82230103915 |
Samsung Medical Center ( Site 0311) Seoul 06351 Korea, Republic of |
Recruiting |
Last Name: Study Coordinator Phone: +82234103409 |
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315) Seoul 06591 Korea, Republic of |
Recruiting |
Last Name: Study Coordinator Phone: +82222582077 |
Hospital Universiti Sains Malaysia ( Site 0295) Kubang Kerian Kelantan 16150 Malaysia |
Recruiting |
Last Name: Study Coordinator Phone: +6097676684 |
Institut Kanser Negara - National Cancer Institute ( Site 0294) Putrajaya Wilayah Persekutuan MYS 62250 Malaysia |
Recruiting |
Last Name: Study Coordinator Phone: +60388925555 |
Sarawak General Hospital ( Site 0293) Kuching Sarawak 93586 Malaysia |
Recruiting |
Last Name: Study Coordinator Phone: +6082276666 |
Penang Adventist Hospital ( Site 0289) George Town 10350 Malaysia |
Recruiting |
Last Name: Study Coordinator Phone: +6042227652 |
Gleneagles Penang ( Site 0290) Penang 10050 Malaysia |
Recruiting |
Last Name: Study Coordinator Phone: +6042285760 |
Auckland City Hospital ( Site 0246) Auckland 1023 New Zealand |
Recruiting |
Last Name: Study Coordinator Phone: +6493074949 |
Christchurch Hospital ( Site 0247) Christchurch 8011 New Zealand |
Recruiting |
Last Name: Study Coordinator Phone: +6433640922 |
Oslo Universitetssykehus HF. Ulleval ( Site 0433) Oslo 0450 Norway |
Recruiting |
Last Name: Study Coordinator Phone: +4723026600 |
Copernicus PL Sp. z o.o. ( Site 0603) Gdansk 80-219 Poland |
Recruiting |
Last Name: Study Coordinator Phone: +48505993747 |
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604) Koszalin 75-581 Poland |
Recruiting |
Last Name: Study Coordinator Phone: +48502204953 |
Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607) Szklarska Poreba 58-580 Poland |
Recruiting |
Last Name: Study Coordinator Phone: +48757547148 |
MTZ Clinical Research Sp. z o. o. ( Site 0608) Warsaw 02-106 Poland |
Recruiting |
Last Name: Study Coordinator Phone: +48661234384 |
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648) Krasnoyarsk 644013 Russian Federation |
Recruiting |
Last Name: Study Coordinator Phone: +79135349316 |
N.N. Blokhin National Medical Oncology Research Centre ( Site 0645) Moscow 115478 Russian Federation |
Recruiting |
Last Name: Study Coordinator Phone: +79031990755 |
City Clinical Hospital 1 na. NI. Pirogov ( Site 0662) Moscow 119049 Russian Federation |
Recruiting |
Last Name: Study Coordinator Phone: +79031991945 |
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661) Moscow 119881 Russian Federation |
Recruiting |
Last Name: Study Coordinator Phone: +79165134577 |
National Medical Research Radiological Centre ( Site 0660) Moscow 125284 Russian Federation |
Recruiting |
Last Name: Study Coordinator Phone: +79039686637 |
Road Hospital JSC Russian railways ( Site 0649) Saint Petersburg 195271 Russian Federation |
Recruiting |
Last Name: Study Coordinator Phone: +79052154918 |
City Clinical Oncology Center ( Site 0646) Saint Petersburg 198255 Russian Federation |
Recruiting |
Last Name: Study Coordinator Phone: +79111019156 |
Samara Regional Clinical Oncology Center ( Site 0656) Samara 443031 Russian Federation |
Recruiting |
Last Name: Study Coordinator Phone: +78469947650 |
Tomsk Scientific Research Institute of Oncology ( Site 0657) Tomsk 634028 Russian Federation |
Recruiting |
Last Name: Study Coordinator Phone: +79039132574 |
Hospital Universitario Puerta de Hierro ( Site 0678) Majadahonda Madrid 28222 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34911917889 |
Hospital Universitari Vall d Hebron ( Site 0674) Barcelona 08035 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34932746140 |
Hospital General Universitario Gregorio Maranon ( Site 0676) Madrid 28007 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34915868308 |
Hospital Ramon y Cajal ( Site 0673) Madrid 28034 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34913368589 |
Hospital Universitario La Paz ( Site 0677) Madrid 28046 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34912071876 |
Hospital Central de Asturias ( Site 0667) Oviedo 33011 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +3498510800039501 |
Hospital Universitario de Donostia ( Site 0671) San Sebastian 20014 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +349430070003662 |
Complejo Hospitalario Universitario de Santiago ( Site 0668) Santiago de Compostela 15706 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34981951367 |
Hospital Universitario Virgen del Rocio ( Site 0670) Sevilla 41013 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34955012065 |
Sahlgrenska Universitetssjukhuset ( Site 0691) Goteborg 413 46 Sweden |
Recruiting |
Last Name: Study Coordinator Phone: +46705259301 |
Skane University Hospital ( Site 0692) Malmo 205 02 Sweden |
Recruiting |
Last Name: Study Coordinator Phone: +46768936655 |
Karolinska Universitetssjukhuset, Huddinge ( Site 0689) Stockholm 141 86 Sweden |
Recruiting |
Last Name: Study Coordinator Phone: +6858587122 |
Norrlands Universitetssjukhus ( Site 0687) Umea 901 85 Sweden |
Recruiting |
Last Name: Study Coordinator Phone: +46907851993 |
Hopitaux Universitaires de Geneve HUG ( Site 0711) Geneve Genève 1211 Switzerland |
Recruiting |
Last Name: Study Coordinator Phone: +41223729861 |
Kantonsspital St. Gallen ( Site 0708) St. Gallen SG 9007 Switzerland |
Recruiting |
Last Name: Study Coordinator Phone: +417474942767 |
Universitaetsspital Basel ( Site 0709) Basel 4031 Switzerland |
Recruiting |
Last Name: Study Coordinator Phone: +41612655174 |
Universitaetsspital Bern ( Site 0710) Bern 3010 Switzerland |
Recruiting |
Last Name: Study Coordinator Phone: +41316328026 |
CHUV Hospital Lausanne ( Site 0712) Lausanne 1011 Switzerland |
Recruiting |
Last Name: Study Coordinator Phone: +41795567902 |
Universitaetsspital Zurich ( Site 0713) Zurich 8091 Switzerland |
Recruiting |
Last Name: Study Coordinator Phone: +41442551111 |
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335) Kaohsiung 833 Taiwan |
Recruiting |
Last Name: Study Coordinator Phone: +88677317123 |
China Medical University Hospital ( Site 0333) Taichung 404 Taiwan |
Recruiting |
Last Name: Study Coordinator Phone: +8864220521211761 |
National Cheng Kung University Hospital ( Site 0334) Tainan 704 Taiwan |
Recruiting |
Last Name: Study Coordinator Phone: 886623535353587 |
National Taiwan University Hospital ( Site 0330) Taipei 100 Taiwan |
Recruiting |
Last Name: Study Coordinator Phone: +886223123456 |
Taipei Veterans General Hospital ( Site 0331) Taipei 112 Taiwan |
Recruiting |
Last Name: Study Coordinator Phone: +886228712121 |
Chang Gung Medical Foundation. Linkou ( Site 0332) Taoyuan 333 Taiwan |
Recruiting |
Last Name: Study Coordinator Phone: +88633281200 |
Siriraj Hospital ( Site 0351) Bangkok 10700 Thailand |
Recruiting |
Last Name: Study Coordinator Phone: +6624194488 |
Maharaj Nakorn Chiangmai Hospital ( Site 0353) Chiang Mai 50200 Thailand |
Recruiting |
Last Name: Study Coordinator Phone: +6653935480 |
Srinagarind Hospital ( Site 0354) Khon Kaen 40002 Thailand |
Recruiting |
Last Name: Study Coordinator Phone: +6643366568 |
Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733) Adana 01120 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +905056166338 |
Ankara Sehir Hastanesi ( Site 0731) Ankara 06800 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +905555306271 |
Adnan Menderes University Medical Faculty ( Site 0737) Aydin 09010 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +905423231635 |
Bezmialem Vakif University School of Medicine ( Site 0732) Istanbul 34093 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +905055618756 |
Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi ( Site 0730) Istanbul 34732 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +905063509061 |
Dokuz Eylul Universitesi ( Site 0740) Izmir 35340 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +90506481389 |
Konya Necmettin Erbakan University Medical Faculty ( Site 0736) Konya 42080 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +905322679838 |
Inonu University Faculty of Medicine ( Site 0729) Malatya 44280 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +905385003562 |
VM Medical Park Hastanesi ( Site 0739) Mersin 33440 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +905354544590 |
Namik Kemal Universitesi Tip Fakultesi ( Site 0738) Tekirdag 59100 Turkey |
Recruiting |
Last Name: Study Coordinator Phone: +905059400839 |
Regional Clinical Onco Dispensary_ State Medical University ( Site 0782) Chernivtsi 58000 Ukraine |
Recruiting |
Last Name: Study Coordinator Phone: +380372547650 |
Regional Oncology Center of Kharkiv ( Site 0777) Kharkiv 61000 Ukraine |
Recruiting |
Last Name: Study Coordinator Phone: +380573151173 |
National Cancer Institute of the MoH of Ukraine ( Site 0779) Kyiv 03022 Ukraine |
Recruiting |
Last Name: Study Coordinator Phone: +380509095151 |
Shalimov s NI of Surgery and Transplantation ( Site 0781) Kyiv 03126 Ukraine |
Recruiting |
Last Name: Study Coordinator Phone: +380939720596 |
MI Odessa Regional Oncological Centre ( Site 0776) Odesa 65055 Ukraine |
Recruiting |
Last Name: Study Coordinator Phone: +380504261911 |
CI City Clinical Hospital # 3 ( Site 0783) Zaporizhzhia 69032 Ukraine |
Recruiting |
Last Name: Study Coordinator Phone: +380612131541 |
University Hospital Coventry and Warwickshire NHS Trust ( Site 0754) Coventry West Midlands CV3 2DX United Kingdom |
Recruiting |
Last Name: Study Coordinator Phone: +441142265000 |
Cambridge University Hospitals NHS Trust ( Site 0755) Cambridge CB2 0QQ United Kingdom |
Recruiting |
Last Name: Study Coordinator Phone: +441223769310 |
Leeds Teaching Hospitals NHS Trust ( Site 0751) Leeds LS9 7TF United Kingdom |
Recruiting |
Last Name: Study Coordinator Phone: +441132433144 |
Kings College Hospital NHS Foundation Trust ( Site 0758) London SE5 9RS United Kingdom |
Recruiting |
Last Name: Study Coordinator Phone: +442032997615 |
Nottingham University Hospitals NHS Trust ( Site 0756) Nottingham NG5 1PB United Kingdom |
Recruiting |
Last Name: Study Coordinator Phone: +4402381204202 |
Location Countries
Country
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
2019-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
2018-004800-20
MK-3475-937
KEYNOTE-937
194786
Number Of Arms
2
Intervention Browse
Mesh Term
Pembrolizumab
Arm Group
Arm Group Label
Pembrolizumab
Arm Group Type
Experimental
Description
Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
Yes
Ipd Description
Ipd Url
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Study First Submitted
March 6, 2019
Study First Submitted Qc
March 6, 2019
Study First Posted
March 7, 2019
Last Update Submitted
December 11, 2019
Last Update Submitted Qc
December 11, 2019
Last Update Posted
December 12, 2019
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.