A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT04199104
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.
Hypotheses include:
* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.
* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 511
- Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.
Note: Participants with newly-diagnosed HNSCC must be M1/Stage IV.
- Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.
Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
- Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period
- Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last
- Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
- Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
- Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
- Have adequately controlled blood pressure with or without antihypertensive medications.
- Has adequate organ function.
- Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (≥Grade 3) or lenvatinib.
- Has pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
- Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption.
- Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident/transient ischemic attack (TIA)/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability.
- Has disease that is suitable for local therapy administered with curative intent.
- Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
- Has had major surgery within 3 weeks before to first dose of study interventions.
- Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube.
- Has received prior therapy with lenvatinib or pembrolizumab.
- Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent.
- 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 (e.g., CTLA-4, OX-40, CD137).
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.).
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection.
- 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 intervention.
- Has had an allogenic tissue/solid organ transplant.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab with Lenvatinib Lenvatinib Participants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity. Pembrolizumab with Placebo Placebo Participants receive lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Pembrolizumab with Lenvatinib Pembrolizumab Participants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity. Pembrolizumab with Placebo Pembrolizumab Participants receive lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months).
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to ~ 37 months OS is the time from randomization to death due to any cause.
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR). Up to ~ 37 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) Up to ~ 37 months ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 is presented.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to ~ 37 months For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.
Percentage of Participants Who Experienced an Adverse Event (AE) Up to ~ 37 months An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percentage of Participants Who Discontinued Study Drug Due to an AE Up to ~ 34 months An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Trial Locations
- Locations (152)
Princess Margaret Cancer Centre ( Site 0200)
🇨🇦Toronto, Ontario, Canada
University of Connecticut Health Center ( Site 0020)
🇺🇸Farmington, Connecticut, United States
Dana Farber Cancer Institute ( Site 0019)
🇺🇸Boston, Massachusetts, United States
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)
🇺🇸Hollywood, Florida, United States
Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)
🇨🇳Nanning, Guangxi, China
Beijing Cancer Hospital ( Site 3314)
🇨🇳Beining, Beijing, China
Chongqing Cancer Hospital ( Site 3327)
🇨🇳Chongqing, Chongqing, China
Fudan University Shanghai Cancer Center ( Site 3324)
🇨🇳Shanghai, Shanghai, China
Oncocentro Ceara ( Site 0412)
🇧🇷Fortaleza, Ceara, Brazil
Universitaetsklinikum Regensburg ( Site 2100)
🇩🇪Regensburg, Bayern, Germany
Chris OBrien Lifehouse ( Site 1002)
🇦🇺Camperdown, New South Wales, Australia
Universitaetsklinikum Tuebingen ( Site 2108)
🇩🇪Tuebingen, Baden-Wurttemberg, Germany
Guizhou Cancer Hospital ( Site 3330)
🇨🇳Guiyang, Guizhou, China
IEO Istituto Europeo di Oncologia ( Site 2406)
🇮🇹Milano, Italy
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
🇨🇦Quebec City, Quebec, Canada
Hopital de la Timone ( Site 1903)
🇫🇷Marseille, Bouches-du-Rhone, France
Hyogo Cancer Center ( Site 1112)
🇯🇵Akashi, Hyogo, Japan
Aichi Cancer Center Hospital ( Site 1113)
🇯🇵Nagoya, Aichi, Japan
Fujian Provincial Cancer Hospital ( Site 3326)
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)
🇨🇳XI An, Shaanxi, China
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400)
🇮🇹Milano, Italy
Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207)
🇭🇺Szeged, Csongrad, Hungary
Hopital Foch ( Site 1905)
🇫🇷Suresnes, Hauts-de-Seine, France
A.C. Camargo Cancer Center ( Site 0407)
🇧🇷Sao Paulo, Brazil
Kagawa University Hospital ( Site 1108)
🇯🇵Kita-gun, Kagawa, Japan
Universitätsklinikum Leipzig-Department for ENT ( Site 2106)
🇩🇪Leipzig, Sachsen, Germany
Nagoya University Hospital ( Site 1106)
🇯🇵Nagoya, Aichi, Japan
Uzsoki Utcai Korhaz ( Site 2201)
🇭🇺Budapest, Vas, Hungary
National Cancer Center Hospital East ( Site 1100)
🇯🇵Kashiwa, Chiba, Japan
Centre Henri Becquerel ( Site 1904)
🇫🇷Rouen, Seine-Maritime, France
Gustave Roussy ( Site 1906)
🇫🇷Villejuif, Val-de-Marne, France
Centre Leon Berard ( Site 1901)
🇫🇷Lyon, Auvergne, France
Hunan Cancer Hospital ( Site 3311)
🇨🇳Changsha, Hunan, China
Xiangya Hospital of Central South University ( Site 3305)
🇨🇳Changsha, Hunan, China
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
🇭🇺Miskolc, Borsod-Abauj-Zemplen, Hungary
The Cancer Institute Hospital of JFCR ( Site 1103)
🇯🇵Tokyo, Japan
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204)
🇰🇷Seoul, Korea, Republic of
Zhejiang Cancer Hospital ( Site 3303)
🇨🇳Hangzhou, Zhejiang, China
KRH Klinikum Siloah ( Site 2103)
🇩🇪Hannover, Niedersachsen, Germany
National Hospital Organization Kyushu Medical Center ( Site 1111)
🇯🇵Fukuoka, Japan
Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604)
🇲🇽Cancun, Quintana Roo, Mexico
Keimyung University Dongsan Hospital ( Site 1203)
🇰🇷Daegu, Taegu-Kwangyokshi, Korea, Republic of
Istituto Oncologico Veneto ( Site 2404)
🇮🇹Padova, Italy
Asan Medical Center ( Site 1201)
🇰🇷Songpa-gu, Seoul, Korea, Republic of
Universitaetsklinikum Ulm ( Site 2102)
🇩🇪Ulm, Baden-Wurttemberg, Germany
Chonnam National University Hwasun Hospital ( Site 1202)
🇰🇷Hwasun-gun, Jeonranamdo, Korea, Republic of
Universitaetsklinikum Frankfurt ( Site 2107)
🇩🇪Frankfurt, Hessen, Germany
Universitaetsklinikum Koeln ( Site 2111)
🇩🇪Koeln, Nordrhein-Westfalen, Germany
Seoul National University Bundang Hospital ( Site 1205)
🇰🇷Seongnam-si, Kyonggi-do, Korea, Republic of
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402)
🇮🇹Brescia, Italy
ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405)
🇮🇹Milano, Italy
National Cancer Center Hospital ( Site 1102)
🇯🇵Tokyo, Japan
Orszagos Onkologiai Intezet ( Site 2202)
🇭🇺Budapest, Hungary
ASL Liguria 2 - Ospedale San Paolo ( Site 2401)
🇮🇹Savona, Italy
Ajou University Hospital ( Site 1200)
🇰🇷Suwon-si, Kyonggi-do, Korea, Republic of
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200)
🇭🇺Szolnok, Jasz-Nagykun-Szolnok, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 2206)
🇭🇺Debrecen, Hungary
Chiba cancer center ( Site 1110)
🇯🇵Chiba-shi, Chiba, Japan
Hiroshima University Hospital ( Site 1109)
🇯🇵Hiroshima, Japan
Royal Marsden Hospital ( Site 2904)
🇬🇧Sutton, London, City Of, United Kingdom
Ankara Sehir Hastanesi ( Site 2802)
🇹🇷Ankara, Turkey
Hospital Universitario La Paz ( Site 2706)
🇪🇸Madrid, Spain
Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)
🇯🇵Sunto-gun, Shizuoka, Japan
Guy's Hospital in London ( Site 2908)
🇬🇧London, London, City Of, United Kingdom
Hospital Universitario 12 de Octubre ( Site 2702)
🇪🇸Madrid, Spain
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)
🇷🇺Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Hospital Duran i Reynals ( Site 2701)
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Kindai University Hospital ( Site 1107)
🇯🇵Osakasayama, Osaka, Japan
Medipol Universite Hastanesi ( Site 2800)
🇹🇷Istanbul, Turkey
Hacettepe Universitesi Tip Fakultesi ( Site 2805)
🇹🇷Ankara, Turkey
Tokyo Medical and Dental University Hospital ( Site 1101)
🇯🇵Tokyo, Japan
Christie NHS Foundation Trust ( Site 2903)
🇬🇧Manchester, United Kingdom
Medical Park Izmir Hospital ( Site 2807)
🇹🇷Izmir, Turkey
H.U. Vall de Hebron ( Site 2700)
🇪🇸Barcelona, Spain
Trakya Universitesi Tip Fakultesi ( Site 2801)
🇹🇷Edirne, Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)
🇹🇷Malatya, Turkey
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509)
🇵🇱Poznan, Wielkopolskie, Poland
Aberdeen Royal Infirmary ( Site 2905)
🇬🇧Aberdeen, Aberdeen City, United Kingdom
Hospital Clinico Universitario Lozano Blesa ( Site 2703)
🇪🇸Zaragoza, Spain
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)
🇹🇷Izmir, Turkey
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Duke Cancer Center ( Site 0044)
🇺🇸Durham, North Carolina, United States
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Passo Fundo ( Site 0401)
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Henry Ford Health System ( Site 0001)
🇺🇸Detroit, Michigan, United States
Karmanos Cancer Institute ( Site 0054)
🇺🇸Detroit, Michigan, United States
Peking Union Medical College Hospital ( Site 3304)
🇨🇳Bejiing, Beijing, China
The Third Affiliated Hospital of Harbin Medical University ( Site 3302)
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 3309)
🇨🇳Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)
🇨🇳Wuhan, Hubei, China
Wuhan Union hospital Cancer Center ( Site 3307)
🇨🇳Wuhan, Hubei, China
Jiangxi Cancer Hospital ( Site 3313)
🇨🇳Nanchang, Jiangxi, China
Shanghai East Hospital ( Site 3300)
🇨🇳Shanghai, Shanghai, China
Jilin Cancer Hospital ( Site 3310)
🇨🇳Changchun, Jilin, China
West China Hospital of Sichuan University ( Site 3308)
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Hospital ( Site 3312)
🇨🇳Tianjin, Tianjin, China
Providence Portland Medical Center ( Site 0048)
🇺🇸Portland, Oregon, United States
Hospital de Valme ( Site 2705)
🇪🇸Sevilla, Spain
Taipei Veterans General Hospital ( Site 1601)
🇨🇳Taipei, Taiwan
University of Colorado Cancer Center ( Site 0023)
🇺🇸Aurora, Colorado, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053)
🇺🇸Omaha, Nebraska, United States
California Cancer Associates for Research & Excellence ( Site 0025)
🇺🇸Fresno, California, United States
California Cancer Associates for Research & Excellence ( Site 0059)
🇺🇸San Marcos, California, United States
Georgia Cancer Center at Augusta University ( Site 0013)
🇺🇸Augusta, Georgia, United States
University of Kansas Cancer Center ( Site 0033)
🇺🇸Westwood, Kansas, United States
Northwest Georgia Oncology Centers PC ( Site 0028)
🇺🇸Marietta, Georgia, United States
St. Vincent Frontier Cancer Center ( Site 0008)
🇺🇸Billings, Montana, United States
Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040)
🇺🇸New York, New York, United States
SUNY Upstate Medical University ( Site 0051)
🇺🇸Syracuse, New York, United States
Washington University School of Medicine ( Site 0060)
🇺🇸Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002)
🇺🇸Hackensack, New Jersey, United States
Inova Schar Cancer Institute ( Site 0009)
🇺🇸Fairfax, Virginia, United States
Blue Ridge Cancer Care ( Site 0015)
🇺🇸Blacksburg, Virginia, United States
St George Hospital ( Site 1001)
🇦🇺Kogarah, New South Wales, Australia
Cancer Care Northwest ( Site 0017)
🇺🇸Spokane Valley, Washington, United States
University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)
🇺🇸Madison, Wisconsin, United States
Royal Adelaide Hospital ( Site 1004)
🇦🇺Adelaide, South Australia, Australia
Fundacao Sao Francisco Xavier ( Site 0409)
🇧🇷Ipatinga, Minas Gerais, Brazil
ELO Pesquisa Clinica ( Site 0405)
🇧🇷Maringa, Parana, Brazil
McGill University Health Centre ( Site 0206)
🇨🇦Montreal, Quebec, Canada
Clinica LACKS ( Site 0402)
🇧🇷Pelotas, Rio Grande Do Sul, Brazil
National Cheng Kung University Hospital ( Site 1603)
🇨🇳Taiwan, Tainan, Taiwan
Yokohama City University Hospital ( Site 1104)
🇯🇵Yokohama, Kanagawa, Japan
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602)
🇲🇽Monterrey, Nuevo Leon, Mexico
Hospital Nacional Cayetano Heredia ( Site 0704)
🇵🇪Lima, Peru
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)
🇵🇱Gliwice, Slaskie, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502)
🇵🇱Krakow, Malopolskie, Poland
Altay Regional Oncology Dispensary ( Site 2611)
🇷🇺Barnaul, Altayskiy Kray, Russian Federation
FSCC FMBA of Russia ( Site 2603)
🇷🇺Moscow, Moskva, Russian Federation
MacKay Memorial Hospital ( Site 1602)
🇨🇳Taipei, Taiwan
Mount Vernon Cancer Centre ( Site 2902)
🇬🇧Northwood, London, City Of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 2910)
🇬🇧London, London, City Of, United Kingdom
University of Louisville, James Graham Brown Cancer Center ( Site 0045)
🇺🇸Louisville, Kentucky, United States
University of Michigan ( Site 0064)
🇺🇸Ann Arbor, Michigan, United States
University of North Carolina- Chapel Hill ( Site 0056)
🇺🇸Chapel Hill, North Carolina, United States
Przychodnia Lekarska Komed ( Site 2500)
🇵🇱Konin, Wielkopolskie, Poland
Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)
🇵🇪Lima, Peru
Hospital Nacional Arzobispo Loayza ( Site 0703)
🇵🇪Lima, Peru
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site
🇵🇱Warszawa, Mazowieckie, Poland
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)
🇨🇳Kaohsiung, Taiwan
Cryptex Investigación Clínica S.A. de C.V. ( Site 0608)
🇲🇽Cuauhtémoc, Mexico City, Distrito Federal, Mexico
Oaxaca Site Management Organization S.C. ( Site 0603)
🇲🇽Oaxaca, Mexico
Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)
🇵🇪Lima, Muni Metro De Lima, Peru
Dolnoslaskie Centrum Onkologii. ( Site 2507)
🇵🇱Wroclaw, Dolnoslaskie, Poland
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504)
🇵🇱Gdynia, Pomorskie, Poland
Nottingham City Hospital ( Site 2907)
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Taunton and Somerset Hospital ( Site 2900)
🇬🇧Taunton, Somerset, United Kingdom
Christus Muguerza Clinica Vidriera ( Site 0607)
🇲🇽Monterrey, Nuevo Leon, Mexico
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)
🇵🇪Lima, Peru
National Taiwan University Hospital ( Site 1600)
🇨🇳Taipei, Taiwan
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)
🇩🇪Berlin, Germany