Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pembrolizumab + Cisplatin + CRT Participants receive a priming dose of pembrolizumab before initiation of CRT (either accelerated or standard fractionation radiotherapy regimen). During CRT, participants receive 2 doses of pembrolizumab and up to 3 cycles of Cisplatin (2 cycles during accelerated and 3 cycles during standard fractionation radiotherapy). Participants also receive up to an additional 14 cycles of pembrolizumab alone as maintenance therapy for a total of 17 cycles of pembrolizumab. If cisplatin and/or radiation therapy is discontinued, the participant may continue on treatment with pembrolizumab. |
Biological: Pembrolizumab
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Other Names:
Drug: Cisplatin
100 mg/m^2 administered as an IV infusion Q3W
Other Names:
Radiation: Accelerated Fractionation (AFX) Radiotherapy
70 Gray (Gy) given in 35 fractions over 6 weeks
Radiation: Standard Fractionation (SFX) Radiotherapy
70 Gy given in 35 fractions over 7 weeks
|
| Placebo Comparator: Placebo + Cisplatin + CRT Participants receive placebo before initiation of CRT (either accelerated or standard fractionation radiotherapy regimen). During CRT, participants receive 2 doses of placebo and up to 3 cycles of Cisplatin (2 cycles during accelerated and 3 cycles during standard fractionation radiotherapy). Participants also receive up to an additional 14 cycles of placebo alone for a total of 17 cycles of placebo. If cisplatin and/or radiation therapy is discontinued, the participant may continue on treatment with placebo. |
Drug: Placebo
Normal saline or dextrose solution administered as an IV infusion Q3W
Drug: Cisplatin
100 mg/m^2 administered as an IV infusion Q3W
Other Names:
Radiation: Accelerated Fractionation (AFX) Radiotherapy
70 Gray (Gy) given in 35 fractions over 6 weeks
Radiation: Standard Fractionation (SFX) Radiotherapy
70 Gy given in 35 fractions over 7 weeks
|
Outcome Measures
Primary Outcome Measures
- Event-free Survival (EFS) [Up to 5 years]
EFS is the time from the date of randomization to the date of first record of disease progression or death.
Secondary Outcome Measures
- Overall Survival (OS) [Up to 5 years]
OS is the time from randomization to death due to any cause.
- Adverse Events (AEs) [From time of first dose of study treatment until the end of follow-up (up to 5 years)]
Number of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy
- Treatment Discontinuations Due to AEs [From time of first dose of study treatment until the end of treatment (up to 1 year)]
Number of participants discontinuing study drug due to an AE
- Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) [Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (up to 5 years)]
Change from baseline in GHS/QoL using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)
- Change From Baseline in Swallowing, Speech, and Pain Symptoms [Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (up to 5 years)]
Change from baseline in swallowing, speech, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)
- Change From Baseline in Physical Functioning [Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (up to 5 years)]
Change From Baseline in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1- 5 Score
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has a pathologically proven new diagnosis of oropharyngeal p16 positive, oropharyngeal p16 negative, or larynx/hypopharynx/oral cavity (independent of p16) squamous cell carcinoma. Participants with oral cavity tumors need to have unresectable disease. Participants with multiple synchronous tumors are not eligible for the study.
-
Has provided tissue for Programmed Cell Death Receptor Ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy. If an excisional or incisional biopsy has been performed, participants remain eligible for the study provided the residual disease meets the staging criteria required for the trial (e.g., excisional biopsy of a lymph node with residual T4 primary). Prior surgical debulking, including tonsillectomy, for the head and neck cancer under study is not allowed.
-
Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1
-
Is eligible for definitive CRT and not considered for primary surgery based on investigator decision
-
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days prior to receiving the first dose of study therapy
-
Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
-
Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy
Exclusion Criteria:
-
Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy
-
Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-PD-L1, anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in clinical studies with pembrolizumab
-
Has received a live vaccine within 30 days prior to the first dose of study therapy
-
Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer
-
Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study
-
Has not recovered from major surgery prior to starting study therapy
-
Has known active Hepatitis B or C
-
Has known history of Human Immunodeficiency Virus (HIV)
-
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
-
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
-
Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
-
Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
-
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
-
Has had previous allogeneic tissue/solid organ transplant
-
Has active infection requiring systemic therapy
-
Has a history of severe hypersensitivity reaction to pembrolizumab, Cisplatin or radiotherapy or their analogs
-
Is pregnant or breast feeding or expecting to conceive or father children throughout the study period and for up to 180 days after the last dose of study therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA Medical Center ( Site 0273) | Los Angeles | California | United States | 90095 |
| 2 | University of California San Francisco ( Site 0274) | San Francisco | California | United States | 94115 |
| 3 | St. Joseph Heritage Healthcare ( Site 0254) | Santa Rosa | California | United States | 95403 |
| 4 | Smilow Cancer Hospital at Yale New Haven ( Site 0256) | New Haven | Connecticut | United States | 06510 |
| 5 | Rush University Medical Center ( Site 0260) | Chicago | Illinois | United States | 60612 |
| 6 | Indiana University ( Site 0264) | Indianapolis | Indiana | United States | 46202 |
| 7 | Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281) | Baton Rouge | Louisiana | United States | 70809 |
| 8 | University of Massachusetts Memorial Medical Center ( Site 0285) | Worcester | Massachusetts | United States | 01655 |
| 9 | University of Michigan Hospital and Health Systems ( Site 0267) | Ann Arbor | Michigan | United States | 48109 |
| 10 | Barbara Ann Karmanos Cancer Institute ( Site 0272) | Detroit | Michigan | United States | 48201 |
| 11 | Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290) | Springfield | Missouri | United States | 65804 |
| 12 | St. Vincent Healthcare Frontier Cancer Center ( Site 0286) | Billings | Montana | United States | 59102 |
| 13 | Comprehensive Cancer Centers of Nevada ( Site 8004) | Las Vegas | Nevada | United States | 89169 |
| 14 | University of Rochester - James P. Wilmot Cancer Center ( Site 0255) | Rochester | New York | United States | 14642 |
| 15 | Oncology Hematology Care, Inc. ( Site 8003) | Cincinnati | Ohio | United States | 45242 |
| 16 | Willamette Valley Cancer Institute and Research Center ( Site 8000) | Eugene | Oregon | United States | 97401 |
| 17 | St. Luke's Cancer Center - Anderson ( Site 0251) | Easton | Pennsylvania | United States | 18045 |
| 18 | St. Francis Hospital Cancer Center ( Site 1461) | Greenville | South Carolina | United States | 29607 |
| 19 | Texas Oncology-Arlington North ( Site 8005) | Arlington | Texas | United States | 76014 |
| 20 | Texas Oncology-Austin Central ( Site 8002) | Austin | Texas | United States | 78731 |
| 21 | Texas Oncology PA ( Site 8001) | Longview | Texas | United States | 75601 |
| 22 | University of Virginia Health System ( Site 0261) | Charlottesville | Virginia | United States | 22908 |
| 23 | Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269) | Seattle | Washington | United States | 98109 |
| 24 | Medical Oncology Associates (Summit Cancer Centers) ( Site 0257) | Spokane | Washington | United States | 99208 |
| 25 | Liverpool Hospital ( Site 0301) | Liverpool | New South Wales (Australia) | Australia | 2170 |
| 26 | Blacktown Hospital Western Sydney Local Health District ( Site 0304) | Blacktown | New South Wales | Australia | 2148 |
| 27 | Princess Alexandra Hospital ( Site 0305) | Brisbane | Queensland | Australia | 4102 |
| 28 | Royal Brisbane and Women s Hospital ( Site 0302) | Herston | Queensland | Australia | 4029 |
| 29 | Royal Adelaide Hospital ( Site 0303) | Adelaide | South Australia | Australia | 5000 |
| 30 | Peter MacCallum Cancer Centre ( Site 0300) | Melbourne | Victoria | Australia | 3000 |
| 31 | Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601) | Graz | Austria | 8036 | |
| 32 | Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603) | Linz | Austria | 4010 | |
| 33 | Landeskrankenhaus Salzburg ( Site 0600) | Salzburg | Austria | 5020 | |
| 34 | Allgemeines Krankenhaus der Stadt Wien ( Site 0602) | Vienna/Wien | Austria | 1090 | |
| 35 | Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651) | Brussels | Belgium | 1200 | |
| 36 | UZ Gent ( Site 0650) | Gent | Belgium | 9000 | |
| 37 | UZ Leuven Campus Gasthuisberg ( Site 0652) | Leuven | Belgium | 3000 | |
| 38 | C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654) | Liege | Belgium | 4000 | |
| 39 | Clinique et Maternite Sainte-Elisabeth ( Site 0653) | Namur | Belgium | 5000 | |
| 40 | Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006) | Salvador | Bahia | Brazil | 40050-410 |
| 41 | Centro Regional Integrado de Oncologia ( Site 0002) | Fortaleza | Ceara | Brazil | 60336-045 |
| 42 | Liga Norte Riograndense Contra o Cancer ( Site 0005) | Natal | Rio Grande Do Norte | Brazil | 59075-740 |
| 43 | Hospital Nossa Senhora da Conceicao ( Site 0001) | Porto Alegre | Rio Grande Do Sul | Brazil | 91350-200 |
| 44 | Hospital de Clinicas de Porto Alegre ( Site 0011) | Porto Alegre | RS | Brazil | 90035-903 |
| 45 | Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003) | Barretos | Sao Paulo | Brazil | 14784-400 |
| 46 | Instituto do Cancer de Sao Paulo - ICESP ( Site 0004) | Sao Paulo | SP | Brazil | 01246-000 |
| 47 | Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008) | Ribeirao Preto | Brazil | 14048-900 | |
| 48 | Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010) | Rio de Janeiro | Brazil | 20230-130 | |
| 49 | Tom Baker Cancer Centre ( Site 0063) | Calgary | Alberta | Canada | T2N 4N2 |
| 50 | Cross Cancer Institute ( Site 0064) | Edmonton | Alberta | Canada | T6G 1Z2 |
| 51 | Juravinski Cancer Centre ( Site 0062) | Hamilton | Ontario | Canada | L8V 5C2 |
| 52 | London Health Sciences Centre ( Site 0055) | London | Ontario | Canada | N6A 4L6 |
| 53 | The Ottawa Hospital - Cancer Care ( Site 0052) | Ottawa | Ontario | Canada | K1H 8L6 |
| 54 | Princess Margaret Cancer Centre ( Site 0051) | Toronto | Ontario | Canada | M5G 1X5 |
| 55 | McGill University Health Centre ( Site 0061) | Montreal | Quebec | Canada | H4A 3J1 |
| 56 | CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057) | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 57 | Hospital Pablo Tobon Uribe ( Site 0151) | Medellin | Antioquia | Colombia | 050034 |
| 58 | Fundacion Valle del Lili ( Site 0150) | Cali | Valle Del Cauca | Colombia | 760032 |
| 59 | Centro Medico Imbanaco de Cali S.A ( Site 0156) | Cali | Valle Del Cauca | Colombia | 760042 |
| 60 | Centro de Investigacion Clinica del Country ( Site 0155) | Bogota | Colombia | 110221 | |
| 61 | FN Brno. ( Site 0703) | Brno | Czechia | 625 00 | |
| 62 | Fakultni Nemocnice Hradec Kralove ( Site 0705) | Hradec Kralove | Czechia | 500 05 | |
| 63 | Fakultni nemocnice Olomouc ( Site 0701) | Olomouc | Czechia | 775 20 | |
| 64 | Fakultni nemocnice Ostrava ( Site 0702) | Ostrava | Czechia | 708 52 | |
| 65 | Nemocnice Na Bulovce ( Site 0700) | Praha 8 | Czechia | 180 81 | |
| 66 | 2. LF UK a FN Motol ( Site 0704) | Praha | Czechia | 150 06 | |
| 67 | Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760) | Le Mans | France | 72000 | |
| 68 | Clinique Francois Chenieux ( Site 0757) | Limoges | France | 87039 | |
| 69 | Institut Claudius Regaud ( Site 0754) | Toulouse Cedex 09 | France | 31059 | |
| 70 | Institut De Cancerologie De Lorraine ( Site 0758) | Vandoeuvre les Nancy | France | 54500 | |
| 71 | Institut Gustave Roussy ( Site 0759) | Villejuif | France | 94805 | |
| 72 | Universitätsklinikum Erlangen ( Site 0801) | Erlangen | Germany | 91054 | |
| 73 | SRH Waldklinikum Gera GmbH ( Site 0802) | Gera | Germany | 07548 | |
| 74 | Universitares Cancer Center Hamburg - UCCH ( Site 0811) | Hamburg | Germany | 20246 | |
| 75 | Medizinische Hochschule Hannover ( Site 0807) | Hannover | Germany | 30325 | |
| 76 | Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803) | Luebeck | Germany | 23538 | |
| 77 | Klinikum der Universitaet Munchen ( Site 0810) | Munchen | Germany | 81377 | |
| 78 | Universitaetsklinik Ulm ( Site 0804) | Ulm | Germany | 89075 | |
| 79 | Rambam MC ( Site 0903) | Haifa | Israel | 3109601 | |
| 80 | Hadassah Ein Karem Jerusalem ( Site 0902) | Jerusalem | Israel | 9112001 | |
| 81 | Rabin Medical Center ( Site 0904) | Petah Tikva | Israel | 4941492 | |
| 82 | Sheba MC ( Site 0901) | Ramat Gan | Israel | 5265601 | |
| 83 | Tel Aviv Sourasky Medical Center ( Site 0900) | Tel Aviv | Israel | 6423906 | |
| 84 | Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954) | Modena | MO | Italy | 41124 |
| 85 | Azienda Ospedaliero Universitaria Careggi ( Site 0955) | Firenze | Italy | 50134 | |
| 86 | Istituto Nazionale Tumori ( Site 0950) | Milano | Italy | 20133 | |
| 87 | Istituto Europeo di Oncologia ( Site 0953) | Milano | Italy | 20141 | |
| 88 | Azienda Ospedaliera San Paolo ( Site 0952) | Milano | Italy | 20142 | |
| 89 | Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951) | Napoli | Italy | 80121 | |
| 90 | Istituto Oncologico Veneto ( Site 0957) | Padova | Italy | 35128 | |
| 91 | Fondazione IRCCS - Policlinico San Matteo ( Site 0960) | Pavia | Italy | 27100 | |
| 92 | National Cancer Center Hospital East ( Site 0350) | Kashiwa | Chiba | Japan | 277-8577 |
| 93 | Hokkaido University Hospital ( Site 0351) | Sapporo | Hokkaido | Japan | 060-8648 |
| 94 | Hyogo Cancer Center ( Site 0354) | Akashi | Hyogo | Japan | 673-8558 |
| 95 | Kagawa University Hospital ( Site 0359) | Kita-gun | Kagawa | Japan | 761-0793 |
| 96 | Miyagi Cancer Center ( Site 0353) | Natori | Miyagi | Japan | 981-1293 |
| 97 | Chiba Cancer Center ( Site 0358) | Chiba | Japan | 260-8717 | |
| 98 | Hiroshima University Hospital ( Site 0352) | Hiroshima | Japan | 734-8551 | |
| 99 | Osaka International Cancer Institute ( Site 0355) | Osaka | Japan | 541-8567 | |
| 100 | Medical Hospital, Tokyo Medical And Dental University ( Site 0356) | Tokyo | Japan | 113-8519 | |
| 101 | The Cancer Institute Hospital of JFCR ( Site 0357) | Tokyo | Japan | 135-8550 | |
| 102 | Chungbuk National University Hospital ( Site 0454) | Cheongju si | Chungcheongbuk Do | Korea, Republic of | 28644 |
| 103 | Seoul National University Bundang Hospital ( Site 0453) | Seongnam-si | Gyeonggi-do | Korea, Republic of | 13620 |
| 104 | Chungnam National University Hospital ( Site 0455) | Daejeon | Korea, Republic of | 35015 | |
| 105 | Severance Hospital Yonsei University Health System ( Site 0452) | Seoul | Korea, Republic of | 03722 | |
| 106 | Samsung Medical Center ( Site 0450) | Seoul | Korea, Republic of | 06351 | |
| 107 | Noordwest Ziekenhuisgroep NWZ ( Site 1350) | Alkmaar | Netherlands | 1815 JD | |
| 108 | VU Medisch Centrum ( Site 1352) | Amsterdam | Netherlands | 1081 HV | |
| 109 | UMCG ( Site 1351) | Groningen | Netherlands | 9713 GZ | |
| 110 | UMC St. Radboud ( Site 1356) | Nijmegen | Netherlands | 6525 GA | |
| 111 | Erasmus University Medical Center ( Site 1354) | Rotterdam | Netherlands | 3015 GD | |
| 112 | Capital & Coast District Health Board - Wellington Hospital ( Site 0400) | Wellington | Newtown | New Zealand | 6021 |
| 113 | Dolnoslaskie Centrum Onkologii. ( Site 1001) | Wroclaw | Dolnoslaskie | Poland | 53-413 |
| 114 | Mazowiecki Szpital Onkologiczny ( Site 1015) | Wieliszew | Mazowieckie | Poland | 05-135 |
| 115 | Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005) | Bielsko-Biala | Poland | 43-300 | |
| 116 | Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007) | Gdynia | Poland | 81-519 | |
| 117 | Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010) | Gliwice | Poland | 44-101 | |
| 118 | Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008) | Krakow | Poland | 31-826 | |
| 119 | Zachodniopomorskie Centrum Onkologii ( Site 1013) | Szczecin | Poland | 71-730 | |
| 120 | Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000) | Warszawa | Poland | 02-781 | |
| 121 | H.U. Vall de Hebron ( Site 1052) | Barcelona | Spain | 08035 | |
| 122 | Hospital Duran i Reynals ( Site 1053) | Hospitalet de Llobregat | Spain | 08907 | |
| 123 | Hospital Doce de Octubre ( Site 1054) | Madrid | Spain | 28024 | |
| 124 | Hospital Universitario Ramon y Cajal ( Site 1055) | Madrid | Spain | 28034 | |
| 125 | Hospital Clinico San Carlos ( Site 1051) | Madrid | Spain | 28040 | |
| 126 | Hospital Universitario Virgen de la Victoria ( Site 1056) | Malaga | Spain | 29010 | |
| 127 | Hospital Gral Universitario de Valencia ( Site 1050) | Valencia | Spain | 46014 | |
| 128 | Chang Gung Medical Foundation - Kaohsiung ( Site 0501) | Kaohsiung | Taiwan | 83301 | |
| 129 | Taichung Veterans General Hospital ( Site 0506) | Taichung | Taiwan | 407 | |
| 130 | National Cheng Kung University Hospital ( Site 0503) | Tainan | Taiwan | 70403 | |
| 131 | National Taiwan University Hospital ( Site 0500) | Taipei | Taiwan | 10048 | |
| 132 | MacKay Memorial Hospital ( Site 0505) | Taipei | Taiwan | 105 | |
| 133 | Taipei Veterans General Hospital ( Site 0504) | Taipei | Taiwan | 112 | |
| 134 | Linkou Chang Gung Memorial Hospital ( Site 0502) | Taoyuan | Taiwan | 333 | |
| 135 | Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103) | Adana | Turkey | 01250 | |
| 136 | Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102) | Ankara | Turkey | 06100 | |
| 137 | Ankara Sehir Hastanesi ( Site 1108) | Ankara | Turkey | 06800 | |
| 138 | Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100) | Istanbul | Turkey | 34093 | |
| 139 | Medipol Universite Hastanesi ( Site 1104) | Istanbul | Turkey | 34214 | |
| 140 | Medical Park Izmir Hastanesi ( Site 1109) | Izmir | Turkey | 35520 | |
| 141 | Kocaeli Universitesi Tip Fakultesi ( Site 1106) | Kocaeli | Turkey | 41380 | |
| 142 | Inonu Universitesi Tip Fakultesi ( Site 1101) | Malatya | Turkey | 44280 | |
| 143 | Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206) | Norwich | Norfolk | United Kingdom | NR4 7UY |
| 144 | University Hospital of North Staffordshire ( Site 1202) | Stoke-On-Trent | Staffordshire | United Kingdom | ST4 6QG |
| 145 | Ipswich Hospital ( Site 1207) | Ipswich | Suffolk | United Kingdom | IP4 5PD |
| 146 | St Bartholomew s Hospital ( Site 1205) | London | United Kingdom | EC1A 7BE | |
| 147 | The Royal Marsden Foundation Trust ( Site 1200) | London | United Kingdom | SW3 6JJ | |
| 148 | Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204) | London | United Kingdom | W6 8RF | |
| 149 | Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208) | Preston | United Kingdom | PR2 9HT | |
| 150 | University Hospital Southampton NHS Foundation Trust ( Site 1203) | Southampton | United Kingdom | SO16 6YD | |
| 151 | Royal Marsden NHS Foundation Trust ( Site 1201) | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 3475-412
- MK-3475-412
- 173640
- KEYNOTE-412
- 2016-003934-25