MedPath

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)

Phase 3
Completed
Conditions
Endometrial Neoplasms
Interventions
Registration Number
NCT03884101
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS).

As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
842
Inclusion Criteria
  • Has Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or nonmeasurable but radiographically apparent, per RECIST 1.1 as assessed by BICR (note: may have received prior chemotherapy only if administered concurrently with radiation; may have received prior radiation without concurrent chemotherapy; may have received prior hormonal therapy for treatment of endometrial carcinoma, provided that it was discontinued ≥1 week prior to randomization; and may have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy)
  • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion that was not previously irradiated, for determination of mismatch repair (MMR) status
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study intervention
  • Is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to use contraception during the study and for ≥120 days after pembrolizumab, ≥30 days after lenvatinib, or ≥180 days after (chemotherapy) [if a WOCBP, a pregnancy test will be required within 24 hours of first dose of study drug]
  • Has adequately controlled blood pressure within 7 days prior to randomization
  • Has adequate organ function based on assessment within 7 days prior to the first dose of study intervention
Exclusion Criteria
  • Has carcinosarcoma (malignant mixed Műllerian tumor), endometrial leiomyosarcoma or other high grade sarcomas, or endometrial stromal sarcomas
  • Has a central nervous system (CNS) metastasis, unless local therapy (e.g., whole brain radiation therapy, surgery, or radiosurgery) has been completed and have discontinued use of corticosteroids for this indication for ≥4 weeks prior to starting study medication (major surgery within 3 weeks of the first dose of study drug will be exclusionary)
  • Has a known additional malignancy (other than endometrial carcinoma) that is progressing or has required active treatment in the last 3 years
  • Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
  • Has a pre-existing Grade ≥3 gastrointestinal or nongastrointestinal fistula
  • Has radiographic evidence of major blood vessel invasion/infiltration
  • Has active hemoptysis (bright red blood at ≥0.5 teaspoon) within 3 weeks prior to the first dose of study intervention or tumor bleeding within 2 weeks prior to randomization
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction or cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
  • Has any infection requiring systemic treatment
  • Has not recovered adequately from any toxicity and/or complications from major surgery prior to randomization
  • Has a known history of human immunodeficiency virus (HIV) infection (HIV test is required at screening)
  • Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) [defined as HCV ribonucleic acid (RNA) is detected] (hepatitis B and C testing is required at screening only when mandated by local health authority)
  • Has a history of (noninfectious) pneumonitis that required treatment with steroids, or has current pneumonitis
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
  • 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 to randomization
  • Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Has received prior systemic chemotherapy in any setting for the treatment of endometrial carcinoma (note: prior chemotherapy administered concurrently with radiation is permitted)
  • Has received prior radiotherapy within 4 weeks prior to randomization (participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis - a 2-week washout is permitted for palliative radiation to non-CNS disease and vaginal brachytherapy)
  • Has received prior hormonal therapy for the treatment of endometrial carcinoma within 1 week of randomization
  • Has received prior therapy with any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis, an anti-programmed cell death (PD)-1, anti-PD ligand (L)1, 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 a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
  • Has known intolerance to study intervention (or any of the excipients)
  • Has had an allogenic tissue/solid organ transplant
  • 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 randomization

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lenvatinib + PembrolizumabLenvatinibParticipants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
Paclitaxel + CarboplatinCarboplatinParticipants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
Paclitaxel + CarboplatinPaclitaxelParticipants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
Lenvatinib + PembrolizumabPembrolizumabParticipants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
Primary Outcome Measures
NameTimeMethod
Progression-free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) ParticipantsUp to approximately 44 months

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred 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 had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of pMMR participants was presented.

PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized ParticipantsUp to approximately 44 months

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred 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 had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of all randomized participants was presented.

Overall Survival (OS) in pMMR ParticipantsUp to approximately 51 months

OS was measured from the time of randomization up to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for pMMR participants is presented.

OS in All Randomized ParticipantsUp to approximately 51 months

OS was measured from the time of randomization up to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all randomized participants is presented.

Secondary Outcome Measures
NameTimeMethod
Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR ParticipantsUp to approximately 51 months

ORR was 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) as assessed using RECIST 1.1. The percentage of pMMR participants who experienced a CR or PR is presented.

ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized ParticipantsUp to approximately 51 months

ORR was defined as the percentage of participants who had a CR: Disappearance of all target lesions or a PR: At least a 30% decrease in the sum of diameters of target lesions as assessed using RECIST 1.1. The percentage of all randomized participants who experienced a CR or PR is presented.

Mean Change From Baseline in the Global Health Status/Quality of Life Score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR ParticipantsBaseline and up to approximately 18 weeks

The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of quality of life (QoL): one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms.

Mean Change From Baseline in the Global Health Status/Quality of Life Score of the EORTC QLQ-C30 in All Randomized ParticipantsBaseline and up to approximately 18 weeks

The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of QoL: one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms.

Percentage of Participants Experiencing an Adverse Event (AE)Up to approximately 27 months (through 90 days after the last dose of study treatment)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Percentage of Participants Experiencing a Serious Adverse Event (SAE)Up to approximately 28 months (through 120 days after the last dose of study treatment)

An SAE is an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital birth defect, or is another important medical event.

Percentage of Participants Experiencing an Immune-Related AE (irAE)Up to approximately 27 months (through 90 days after the last dose of study treatment)

Immune-related AEs will be monitored in both arms.

Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)Up to approximately 24 months (through the last dose of study treatment)

Discontinuations related to AEs will be monitored in both arms.

Trial Locations

Locations (195)

UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233)

🇺🇸

Los Angeles, California, United States

University of Rochester ( Site 0238)

🇺🇸

Rochester, New York, United States

Faculdade de Medicina da Universidade Federal de Minas Gerais ( Site 2708)

🇧🇷

Belo Horizonte, Minas Gerais, Brazil

University of Miami Health System ( Site 0249)

🇺🇸

Miami, Florida, United States

Roger Maris Cancer Center ( Site 0277)

🇺🇸

Fargo, North Dakota, United States

Ospedale Antonio Perrino ( Site 0806)

🇮🇹

Brindisi, Italy

Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 0268)

🇺🇸

Basking Ridge, New Jersey, United States

Arizona Oncology Associates PC- HOPE ( Site 8005)

🇺🇸

Tucson, Arizona, United States

Sanford Cancer Center Oncology Clinic ( Site 0205)

🇺🇸

Sioux Falls, South Dakota, United States

MSKCC-Bergen ( Site 0276)

🇺🇸

Montvale, New Jersey, United States

Hospital Italiano de La Plata ( Site 2601)

🇦🇷

La Plata, Buenos Aires, Argentina

Cork University Hospital ( Site 1400)

🇮🇪

Cork, Ireland

Ospedale dell Angelo ( Site 0810)

🇮🇹

Mestre, Venezia, Italy

Holy Name Medical Center ( Site 0235)

🇺🇸

Teaneck, New Jersey, United States

Princess Margaret Cancer Centre ( Site 0409)

🇨🇦

Toronto, Ontario, Canada

Medizinische Universitat Innsbruck ( Site 3302)

🇦🇹

Innsbruck, Tirol, Austria

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0414)

🇨🇦

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0404)

🇨🇦

Montreal, Quebec, Canada

Universitaetsklinikum Essen ( Site 0616)

🇩🇪

Essen, Nordrhein-Westfalen, Germany

Universitaetsklinikum Jena ( Site 0612)

🇩🇪

Jena, Thuringen, Germany

Cross Cancer Institute ( Site 0408)

🇨🇦

Edmonton, Alberta, Canada

Willamette Valley Cancer Institute and Research Center ( Site 8004)

🇺🇸

Eugene, Oregon, United States

Cliniques Universitaires Saint-Luc ( Site 3203)

🇧🇪

Brussels, Bruxelles-Capitale, Region De, Belgium

AZ Maria Middelares Gent ( Site 3202)

🇧🇪

Gent, Oost-Vlaanderen, Belgium

Universitaetsklinikum Muenster ( Site 0615)

🇩🇪

Muenster, Baden-Wurttemberg, Germany

HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623)

🇩🇪

Wiesbaden, Hessen, Germany

Medical Oncology Ospedale San Donato ( Site 0812)

🇮🇹

Arezzo, Italy

Ospedale Policlinico S. Orsola-Malpighi ( Site 0803)

🇮🇹

Bologna, Italy

Women's Cancer Care ( Site 0208)

🇺🇸

Covington, Louisiana, United States

Hospital San Lucas Cardiologica del Sureste ( Site 3103)

🇲🇽

Tuxtla Gutierrez, Chiapas, Mexico

Consultorio Dentro de la Torre Medica Dalinde Oncologia Medica ( Site 3108)

🇲🇽

Ciudad de Mexico, Mexico

National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1103)

🇷🇺

Saint-Petersburg, Sankt-Peterburg, Russian Federation

John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0226)

🇺🇸

Hackensack, New Jersey, United States

Maine Medical Partners ( Site 0217)

🇺🇸

Scarborough, Maine, United States

Mater Misericordiae Ltd ( Site 1608)

🇦🇺

South Brisbane, Queensland, Australia

Monash Health ( Site 1606)

🇦🇺

Clayton, Victoria, Australia

Juravinski Cancer Centre ( Site 0406)

🇨🇦

Hamilton, Ontario, Canada

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2607)

🇦🇷

Caba, Buenos Aires, Argentina

Medizinische Universitat Wien ( Site 3300)

🇦🇹

Vienna, Wien, Austria

UZA University Hospital Antwerp ( Site 3204)

🇧🇪

Edegem, Antwerpen, Belgium

Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2702)

🇧🇷

Goiania, Goias, Brazil

A.C. Camargo Cancer Center ( Site 2705)

🇧🇷

Sao Paulo, Brazil

Universitaetsmedizin Mannheim. Klinik fuer Kinder und Jugendmedizin ( Site 0622)

🇩🇪

Mannheim, Baden-Wurttemberg, Germany

University of the Ryukyus Hospital ( Site 2412)

🇯🇵

Nakagami-gun, Okinawa, Japan

Kingston Health Sciences Centre ( Site 0401)

🇨🇦

Kingston, Ontario, Canada

The Credit Valley Hospital ( Site 0403)

🇨🇦

Mississauga, Ontario, Canada

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2606)

🇦🇷

Mar del Plata, Buenos Aires, Argentina

Hospital Aleman ( Site 2600)

🇦🇷

Buenos Aires, Argentina

Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 3301)

🇦🇹

Graz, Steiermark, Austria

UZ Leuven ( Site 3200)

🇧🇪

Leuven, Antwerpen, Belgium

Epworth Freemasons Hospital ( Site 1609)

🇦🇺

Melbourne, Victoria, Australia

Instituto Nacional do Cancer II ( Site 2707)

🇧🇷

Rio de Janeiro, Brazil

Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)

🇧🇷

Sao Paulo, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713)

🇧🇷

Sao Paulo, Brazil

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0801)

🇮🇹

Bari, Italy

Istituto Nazionale Tumori Fondazione Pascale ( Site 0808)

🇮🇹

Napoli, Italy

Gunma Prefectural Cancer Center ( Site 2404)

🇯🇵

Ota, Gunma, Japan

BC Cancer-Vancouver Center ( Site 0412)

🇨🇦

Vancouver, British Columbia, Canada

BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0402)

🇨🇦

Kelowna, British Columbia, Canada

Charite Universitaetsmedizin Berlin ( Site 0609)

🇩🇪

Berlin, Germany

Chaim Sheba Medical Center ( Site 0707)

🇮🇱

Ramat Gan, Israel

Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0807)

🇮🇹

Catania, Italy

I CAN Oncology SA de SV ( Site 3102)

🇲🇽

Monterrey, Nuevo Leon, Mexico

Centro Oncologico Internacional. SEDNA ( Site 3106)

🇲🇽

Mexico City, Mexico

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1008)

🇵🇱

Lublin, Dolnoslaskie, Poland

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108)

🇷🇺

Kazan, Tatarstan, Respublika, Russian Federation

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 1507)

🇺🇦

Kyiv, Kyivska Oblast, Ukraine

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0800)

🇮🇹

Meldola, Emilia-Romagna, Italy

National Hospital Organization Hokkaido Cancer Center ( Site 2408)

🇯🇵

Sapporo, Hokkaido, Japan

Saitama Medical University International Medical Center ( Site 2410)

🇯🇵

Hidaka, Saitama, Japan

Showa University Hospital ( Site 2419)

🇯🇵

Tokyo, Japan

SPb SBHI City Clinical Oncological Dispensary ( Site 1104)

🇷🇺

Saint Petersburg, Sankt-Peterburg, Russian Federation

Linkou Chang Gung Memorial Hospital ( Site 1901)

🇨🇳

Taoyuan, Taiwan

National Defense Medical College Hospital ( Site 2418)

🇯🇵

Tokorozawa, Saitama, Japan

Keio University Hospital ( Site 2411)

🇯🇵

Tokyo, Japan

Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1004)

🇵🇱

Poznan, Wielkopolskie, Poland

Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118)

🇷🇺

Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation

Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1100)

🇷🇺

Moscow, Moskva, Russian Federation

FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1102)

🇷🇺

Moscow, Moskva, Russian Federation

Taichung Veterans General Hospital ( Site 1902)

🇨🇳

Taichung, Taiwan

MI Odessa Regional Oncological Centre ( Site 1504)

🇺🇦

Odesa, Odeska Oblast, Ukraine

Asan Medical Center ( Site 1800)

🇰🇷

Seoul, Korea, Republic of

Osaka International Cancer Institute ( Site 2409)

🇯🇵

Osaka, Japan

St.Petersburg Clinical Hospital RAS ( Site 1124)

🇷🇺

Saint Petersburg, Sankt-Peterburg, Russian Federation

Railway Hospital of OJSC ( Site 1122)

🇷🇺

Saint-Petersburg, Sankt-Peterburg, Russian Federation

Siberian State Medical University ( Site 1121)

🇷🇺

Tomsk, Tomskaya Oblast, Russian Federation

Cukurova Uni. Tip Fakultesi ( Site 1302)

🇹🇷

Adana, Turkey

Kyiv City Clinical Oncology Centre ( Site 1505)

🇺🇦

Kyiv, Ukraine

MI Precarpathian Clinical Oncology Center ( Site 1503)

🇺🇦

Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine

Baskent Universitesi Ankara Hastanesi ( Site 1300)

🇹🇷

Ankara, Turkey

Communal non profit enterprise Regional Clinical Oncology Center ( Site 1509)

🇺🇦

Kharkiv, Kharkivska Oblast, Ukraine

University of South Alabama, Mitchell Cancer Institute ( Site 0245)

🇺🇸

Mobile, Alabama, United States

Georgia Cancer Center at Augusta University ( Site 0222)

🇺🇸

Augusta, Georgia, United States

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273)

🇺🇸

Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center - West Harrison ( Site 0274)

🇺🇸

Harrison, New York, United States

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0206)

🇺🇸

New York, New York, United States

Memorial Sloan-Kettering Cancer Center at Commack ( Site 0267)

🇺🇸

Commack, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0246)

🇺🇸

New York, New York, United States

Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275)

🇺🇸

Uniondale, New York, United States

Legacy Salmon Creek Medical Center ( Site 0253)

🇺🇸

Vancouver, Washington, United States

University of Texas Southwestern Medical Center ( Site 0264)

🇺🇸

Dallas, Texas, United States

Parkland Health & Hospital System ( Site 0272)

🇺🇸

Dallas, Texas, United States

Hospital Italiano de Buenos Aires ( Site 2603)

🇦🇷

Buenos Aires, Argentina

Centro Oncologico Riojano Integral ( Site 2605)

🇦🇷

La Rioja, Argentina

Chris OBrien Lifehouse ( Site 1605)

🇦🇺

Camperdown, New South Wales, Australia

Prince of Wales Hospital [Australia] ( Site 1603)

🇦🇺

Randwick, New South Wales, Australia

Royal North Shore Hospital ( Site 1600)

🇦🇺

St Leonards, New South Wales, Australia

The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 1602)

🇦🇺

Westmead, New South Wales, Australia

Sir Charles Gairdner Hospital ( Site 1604)

🇦🇺

Nedlands, Western Australia, Australia

Hospital de Caridade de Ijui ( Site 2712)

🇧🇷

Ijui, Rio Grande Do Sul, Brazil

AZ Delta ( Site 3206)

🇧🇪

Roeselare, West-Vlaanderen, Belgium

Instituto do Cancer do Ceara ( Site 2703)

🇧🇷

Fortaleza, Ceara, Brazil

Hospital de Base de Sao Jose de Rio Preto ( Site 2704)

🇧🇷

Sao Jose do Rio Preto, Sao Paulo, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 2701)

🇧🇷

Porto Alegre, Rio Grande Do Sul, Brazil

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0411)

🇨🇦

Montreal, Quebec, Canada

Anhui Provincial Cancer Hospital ( Site 2509)

🇨🇳

Hefei, Anhui, China

Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505)

🇨🇳

Beijing, Beijing, China

Peking Union Medical College Hospital ( Site 2501)

🇨🇳

Beijing, Beijing, China

Chongqing Cancer Hospital ( Site 2513)

🇨🇳

Chongqing, Chongqing, China

Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517)

🇨🇳

Nanning, Guangxi, China

Beijing Cancer Hospital ( Site 2504)

🇨🇳

Beijing, Beijing, China

Hubei Cancer Hospital ( Site 2510)

🇨🇳

Wuhan, Hubei, China

Nanjing Maternity and Child Health Care Hospital ( Site 2508)

🇨🇳

Nanjing, Jiangsu, China

The First Affiliated Hospital.Sun Yat-sen University ( Site 2507)

🇨🇳

Guangzhou, Guangdong, China

The first affiliated Hospital of Xi an Jiaotong University ( Site 2502)

🇨🇳

XI An, Shaanxi, China

Fudan University Shanghai Cancer Center ( Site 2500)

🇨🇳

Shanghai, Shanghai, China

Xiangya Hospital Central-South University ( Site 2512)

🇨🇳

Changsha, Hunan, China

The First Affiliated Hospital of Xinjiang Medical University ( Site 2515)

🇨🇳

Urumqi, Xinjiang, China

Caritas-Krankenhaus St. Josef Regensburg ( Site 0613)

🇩🇪

Regensburg, Bayern, Germany

Women s Hospital School of Medicine Zhejiang University ( Site 2511)

🇨🇳

Hangzhou, Zhejiang, China

Obstetrics and Gynecology Hosp. Fudan University ( Site 2503)

🇨🇳

Shanghai, Shanghai, China

Zhejiang Cancer Hospital ( Site 2506)

🇨🇳

Hangzhou, Zhejiang, China

St James Hospital ( Site 1401)

🇮🇪

Dublin, Ireland

Edith Wolfson Medical Center ( Site 0703)

🇮🇱

Holon, Tell Abib, Israel

Meir Medical Center ( Site 0702)

🇮🇱

Kfar-Saba, Central, Israel

Rambam Medical Center ( Site 0700)

🇮🇱

Haifa, Israel

Policlinico Universitario Agostino Gemelli ( Site 0805)

🇮🇹

Rome, Roma, Italy

Ehime University Hospital ( Site 2413)

🇯🇵

Toon, Ehime, Japan

Kurume University Hospital ( Site 2403)

🇯🇵

Kurume, Fukuoka, Japan

Nippon Medical School Musashi Kosugi Hospital ( Site 2417)

🇯🇵

Kawasaki, Kanagawa, Japan

Hyogo Cancer Center ( Site 2414)

🇯🇵

Akashi, Hyogo, Japan

St. Marianna University School of Medicine Hospital ( Site 2416)

🇯🇵

Kawasaki, Kanagawa, Japan

Saitama Cancer Center ( Site 2406)

🇯🇵

Kitaadachi-gun, Saitama, Japan

Kyorin University Hospital ( Site 2402)

🇯🇵

Mitaka, Tokyo, Japan

Niigata Cancer Center Hospital ( Site 2415)

🇯🇵

Niigata, Japan

National Hospital Organization Kyushu Cancer Center ( Site 2405)

🇯🇵

Fukuoka, Japan

The Cancer Institute Hospital of JFCR ( Site 2401)

🇯🇵

Tokyo, Japan

Seoul National University Bundang Hospital ( Site 1802)

🇰🇷

Seongnam-si, Kyonggi-do, Korea, Republic of

Severance Hospital Yonsei University Health System ( Site 1804)

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center ( Site 1803)

🇰🇷

Seoul, Korea, Republic of

Centro de Investigacion Clinica Gramel ( Site 3107)

🇲🇽

Mexico City, Mexico

Centro Estatal de Cancerologia de Chihuahua ( Site 3101)

🇲🇽

Chihuahua, Mexico

Instytut Centrum Zdrowia Matki Polki ( Site 1020)

🇵🇱

Lodz, Lodzkie, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1019)

🇵🇱

Krakow, Malopolskie, Poland

Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011)

🇵🇱

Warszawa, Mazowieckie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1009)

🇵🇱

Warsaw, Mazowieckie, Poland

Bialostockie Centrum Onkologii ( Site 1005)

🇵🇱

Bialystok, Podlaskie, Poland

Centrum Onkologii Instytut im. MSC Oddział w Gliwicach ( Site 1017)

🇵🇱

Gliwice, Slaskie, Poland

Samara Regional Clinical Oncology Center ( Site 1117)

🇷🇺

Samara, Samarskaya Oblast, Russian Federation

Medical Rehabilitation Center ( Site 1101)

🇷🇺

Moscow, Moskva, Russian Federation

Institut Catala d Oncologia Badalona ( Site 1201)

🇪🇸

Badalona, Barcelona, Spain

Instituto Valenciano de Oncologia - IVO ( Site 1205)

🇪🇸

Valencia, Valenciana, Comunitat, Spain

Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202)

🇪🇸

A Coruna, La Coruna, Spain

Hospital General Universitario de Valencia ( Site 1203)

🇪🇸

Valencia, Valenciana, Comunitat, Spain

Parc de Salut Mar ( Site 1200)

🇪🇸

Barcelona, Spain

Hospital Clinico San Carlos ( Site 1209)

🇪🇸

Madrid, Spain

Hospital Universitario Reina Sofia ( Site 1207)

🇪🇸

Cordoba, Spain

National Taiwan University Hospital ( Site 1904)

🇨🇳

Taipei, Taiwan

China Medical University Hospital ( Site 1903)

🇨🇳

Taichung, Taiwan

Hospital Materno Infantil [Malaga, Spain] ( Site 1208)

🇪🇸

Malaga, Spain

Taipei Veterans General Hospital ( Site 1900)

🇨🇳

Taipei, Taiwan

Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303)

🇹🇷

Adana, Turkey

Uludag Universitesi Tip Fakultesi ( Site 1307)

🇹🇷

Bursa, Turkey

Gazi Universitesi Tip Fakultesi ( Site 1308)

🇹🇷

Ankara, Turkey

Akdeniz Universitesi Tıp Fakultesi ( Site 1301)

🇹🇷

Antalya, Turkey

City Clinical Hosp.4 of DCC ( Site 1501)

🇺🇦

Dnipro, Dnipropetrovska Oblast, Ukraine

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1511)

🇺🇦

Kharkiv, Kharkivska Oblast, Ukraine

Khmelnitskiy Regional Onkology Dispensary ( Site 1513)

🇺🇦

Khmelnitskiy, Khmelnytska Oblast, Ukraine

Medical Center Asklepion LLC ( Site 1514)

🇺🇦

Khodosivka, Kyivska Oblast, Ukraine

National Cancer Institute of the MoH of Ukraine ( Site 1510)

🇺🇦

Kyiv, Kyivska Oblast, Ukraine

Western General Hospital ( Site 1411)

🇬🇧

Edinburgh, Edinburgh, City Of, United Kingdom

UCLH NHS Foundation Trust ( Site 1405)

🇬🇧

London, London, City Of, United Kingdom

Mount Vernon Cancer Centre ( Site 1409)

🇬🇧

Northwood, London, City Of, United Kingdom

Churchill Hospital ( Site 1406)

🇬🇧

Oxford, Oxfordshire, United Kingdom

The James Cook University Hospital ( Site 1403)

🇬🇧

Middlesbrough, United Kingdom

Northern Centre for Cancer Care ( Site 1408)

🇬🇧

Newcastle Upon Tyne, United Kingdom

Texas Oncology-The Woodlands ( Site 8000)

🇺🇸

The Woodlands, Texas, United States

Sunnybrook Research Institute ( Site 0410)

🇨🇦

Toronto, Ontario, Canada

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0417)

🇨🇦

Sherbrooke, Quebec, Canada

Seoul National University Hospital ( Site 1801)

🇰🇷

Seoul, Korea, Republic of

Minnesota Oncology Hematology, PA ( Site 8003)

🇺🇸

Minneapolis, Minnesota, United States

University of Colorado Cancer Center ( Site 0204)

🇺🇸

Aurora, Colorado, United States

University of North Carolina- Chapel Hill ( Site 0254)

🇺🇸

Chapel Hill, North Carolina, United States

Smilow Cancer Hospital at Yale New Haven ( Site 0202)

🇺🇸

New Haven, Connecticut, United States

Clinical oncology dispensary of Dnipro ( Site 1512)

🇺🇦

Dnipro, Dnipropetrovska Oblast, Ukraine

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