MedPath

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Phase 3
Completed
Conditions
Colorectal Cancer
Interventions
Registration Number
NCT05064059
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil).

The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
441
Inclusion Criteria
  • Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.
  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator.
  • Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
  • Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
  • Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.
  • Has a life expectancy of at least 3 months, based on the investigator assessment.
  • Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.
  • Has adequate organ function.
Exclusion Criteria
  • Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
  • Has a history of acute or chronic pancreatitis.
  • Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
  • 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, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
  • Has urine protein greater than or equal to 1g/24h.
  • A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention.
  • Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
  • Has previously received regorafenib or TAS-102.
  • Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.
  • Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • 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 history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infections, etc.).
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has known history of Hepatitis B or known active Hepatitis C virus infection.
  • 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 had an allogenic tissue/solid organ transplant.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Favezelimab/Pembrolizumabfavezelimab/pembrolizumabParticipants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.
Standard of Care (Regorafenib or TAS-102)regorafenibAt the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.
Standard of Care (Regorafenib or TAS-102)TAS-102At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.
Primary Outcome Measures
NameTimeMethod
Overall Survival (OS)Up to approximately 26 months

OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures
NameTimeMethod
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICRUp to approximately 19 months

The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR.

Duration of Response (DOR) per RECIST 1.1 as Assessed by BICRUp to approximately 19 months

For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 24 months

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. The number of participants who discontinue study treatment due to an AE will be reported.

Progression-Free Survival (PFS) according per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)Up to approximately 19 months

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.

Number of Participants Who Experience at least One Adverse Event (AE)Up to approximately 27 months

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.

Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined ScoreBaseline and up to approximately 25 months

TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in GHS (EORTC QLQ-C30 Item 29) \& QoL combined score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.

TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined ScoreBaseline and up to approximately 25 months

TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.

TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) ScoreBaseline and up to approximately 25 months

TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.

TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) ScoreBaseline and up to approximately 25 months

TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome.

Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined ScoreBaseline and up to approximately 25 months

The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented. A higher score indicates a better outcome.

Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) ScoreBaseline and up to approximately 25 months

The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function.

Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) ScoreBaseline and up to approximately 25 months

The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented.

Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) ScoreBaseline and up to approximately 25 months

The EORTC QLQ-CR29 is a health-related quality-of life (QoL) questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented.

Trial Locations

Locations (152)

Fujian Province Cancer Hospital ( Site 1178)

🇨🇳

Fuzhou, Fujian, China

Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)

🇨🇳

Nanning, Guangxi, China

Wuhan Union Hospital Cancer Center ( Site 1162)

🇨🇳

Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 1152)

🇨🇳

Wuhan, Hubei, China

Xiangya Hospital Central South University ( Site 1171)

🇨🇳

Changsha, Hunan, China

Changzhou Cancer Hospital-Department of Oncology ( Site 1183)

🇨🇳

Changzhou, Jiangsu, China

Zhejiang Cancer Hospital ( Site 1180)

🇨🇳

Hangzhou, Zhejiang, China

Jinan Central Hospital ( Site 1167)

🇨🇳

Jinan, Shandong, China

Fudan University Shanghai Cancer Center ( Site 1176)

🇨🇳

Shangai, Shanghai, China

West China Hospital Sichuan University ( Site 1172)

🇨🇳

Chengdu, Sichuan, China

Baskent Universitesi Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1007)

🇹🇷

Adana, Turkey

Acibadem Adana Hastanesi ( Site 1008)

🇹🇷

Adana, Turkey

Gulhane Egitim ve Arastirma Hastanesi ( Site 1009)

🇹🇷

Ankara, Turkey

Ege Universitesi Tip Fakultesi Hastanesi ( Site 1006)

🇹🇷

Izmir, Turkey

Rutgers Cancer Institute of New Jersey ( Site 1105)

🇺🇸

New Brunswick, New Jersey, United States

Blue Ridge Cancer Care ( Site 1718)

🇺🇸

Roanoke, Virginia, United States

Royal Brisbane and Women s Hospital ( Site 0058)

🇦🇺

Herston, Queensland, Australia

Seattle Cancer Care Alliance ( Site 1107)

🇺🇸

Seattle, Washington, United States

Western Health-Sunshine & Footscray Hospitals ( Site 0052)

🇦🇺

St Albans, Victoria, Australia

Chongqing Cancer Hospital ( Site 1151)

🇨🇳

Chongqing, Chongqing, China

Sun Yat-Sen University Cancer Center ( Site 1150)

🇨🇳

Guangzhou, Guangdong, China

St John of God Subiaco Hospital ( Site 0051)

🇦🇺

Perth, Western Australia, Australia

Jilin Cancer Hospital ( Site 1163)

🇨🇳

Changchun, Jilin, China

Katholisches Marienkrankenhaus gGmbH ( Site 1257)

🇩🇪

Hamburg, Germany

Fakultni Thomayerova nemocnice ( Site 1205)

🇨🇿

Praha 4, Czechia

Fakultni nemocnice Hradec Kralove ( Site 1207)

🇨🇿

Hradec Kralove, Czechia

LMU Klinikum Grosshadern der Universitaet Muenchen ( Site 1253)

🇩🇪

Muenchen, Bayern, Germany

Bnei Zion Medical Center ( Site 0506)

🇮🇱

Haifa, Israel

Assuta Ashdod Public ( Site 0507)

🇮🇱

Ashdod, Israel

Hadassa Ein Karem Medical Center ( Site 0504)

🇮🇱

Jerusalem, Israel

Chaim Sheba Medical Center ( Site 0501)

🇮🇱

Ramat Gan, Israel

Hopital Europeen Georges Pompidou ( Site 0300)

🇫🇷

Paris, France

Tianjin Medical University Cancer Institute and Hospital ( Site 1161)

🇨🇳

Tianjin, Tianjin, China

Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)

🇨🇳

Kunming, Yunnan, China

Fakultni nemocnice Kralovske Vinohrady ( Site 1208)

🇨🇿

Praha 10, Czechia

Klinikum Wolfsburg ( Site 1256)

🇩🇪

Wolfsburg, Niedersachsen, Germany

Masarykuv onkologicky ustav ( Site 1203)

🇨🇿

Brno, Brno-mesto, Czechia

Philipps-Universitaet Marburg. ( Site 1252)

🇩🇪

Marburg, Hessen, Germany

Kliniken Maria Hilf GmbH ( Site 1255)

🇩🇪

Moenchengladbach, Nordrhein-Westfalen, Germany

Rambam Health Care Campus-Oncology Division ( Site 0500)

🇮🇱

Haifa, Israel

Fakultni nemocnice v Motole ( Site 1201)

🇨🇿

Praha, Praha, Hlavni Mesto, Czechia

Universita degli Studi della Campania Luigi Vanvitelli-UOC Oncoematologia ( Site 0556)

🇮🇹

Napoli, Italy

A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0553)

🇮🇹

Catania, Italy

Japanese Foundation for Cancer Research ( Site 0602)

🇯🇵

Tokyo, Japan

Oslo Universitetssykehus HF. Ulleval ( Site 1351)

🇳🇴

Oslo, Norway

Seoul National University Hospital ( Site 0653)

🇰🇷

Seoul, Korea, Republic of

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0871)

🇷🇺

Ufa, Baskortostan, Respublika, Russian Federation

Severance Hospital ( Site 0652)

🇰🇷

Seoul, Korea, Republic of

Kagawa University Hospital ( Site 0608)

🇯🇵

Kita-gun, Kagawa, Japan

Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0872)

🇷🇺

Tomsk, Tomskaya Oblast, Russian Federation

National Cancer Center Hospital East ( Site 0600)

🇯🇵

Kashiwa, Chiba, Japan

National Cancer Center Hospital ( Site 0601)

🇯🇵

Tokyo, Japan

Asan Medical Center ( Site 0650)

🇰🇷

Songpagu, Seoul, Korea, Republic of

Hospital Universitari Vall d Hebron ( Site 0900)

🇪🇸

Barcelona, Spain

Royal Marsden NHS Trust ( Site 1063)

🇬🇧

Sutton, London, City Of, United Kingdom

National Cheng Kung University Hospital ( Site 0955)

🇨🇳

Tainan, Taiwan

Hospital Clinico San Carlos ( Site 0902)

🇪🇸

Madrid, Spain

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0850)

🇷🇺

Yaroslavl, Yaroslavskaya Oblast, Russian Federation

Goztepe Prof.Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1002)

🇹🇷

Istanbul, Turkey

University Hospital Coventry & Warwickshire ( Site 1062)

🇬🇧

Coventry, Warwickshire, United Kingdom

University College London Hospitals NHS Foundation Trust ( Site 1056)

🇬🇧

London, Camden, United Kingdom

Royal Marsden NHS Foundation Trust ( Site 1064)

🇬🇧

London, London, City Of, United Kingdom

London Regional Cancer Program - London HSC ( Site 0154)

🇨🇦

London, Ontario, Canada

FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 0851)

🇷🇺

Moscow, Moskva, Russian Federation

Queen Elizabeth Hospital ( Site 0050)

🇦🇺

Woodville South, South Australia, Australia

Sibley Memorial Hospital ( Site 1143)

🇺🇸

Washington, District of Columbia, United States

Georgetown University Hospital ( Site 1148)

🇺🇸

Washington, District of Columbia, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)

🇺🇸

Marietta, Georgia, United States

Memorial Sloan Kettering Cancer Center ( Site 1703)

🇺🇸

New York, New York, United States

Oregon Health & Science University ( Site 1141)

🇺🇸

Portland, Oregon, United States

The West Clinic, PLLC dba West Cancer Center ( Site 1149)

🇺🇸

Germantown, Tennessee, United States

Intermountain Medical Center ( Site 1707)

🇺🇸

Murray, Utah, United States

UT Southwestern Medical Center ( Site 1709)

🇺🇸

Dallas, Texas, United States

Frankston Hospital ( Site 0056)

🇦🇺

Frankston, Victoria, Australia

Westmead Hospital ( Site 0057)

🇦🇺

Westmead, New South Wales, Australia

IC La Serena Research ( Site 0202)

🇨🇱

La Serena, Coquimbo, Chile

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0155)

🇨🇦

Toronto, Ontario, Canada

Centro Investigacion Cancer James Lind ( Site 0204)

🇨🇱

Temuco, Araucania, Chile

Clinica Puerto Montt ( Site 0211)

🇨🇱

Puerto Montt, Los Lagos, Chile

Fundacion Arturo Lopez Perez FALP ( Site 0208)

🇨🇱

Santiago, Region M. De Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 0206)

🇨🇱

Santiago, Region M. De Santiago, Chile

The Second Affiliated Hospital of Anhui Medical University ( Site 1179)

🇨🇳

Hefei, Anhui, China

Hunan Cancer Hospital ( Site 1174)

🇨🇳

Changsha, Hunan, China

Hainan General Hospital ( Site 1177)

🇨🇳

Haikou, Hainan, China

The Third Xiangya Hospital of Central South University ( Site 1175)

🇨🇳

Changsha, Hunan, China

Shanghai Tenth People's Hospital ( Site 1170)

🇨🇳

Shanghai, Shanghai, China

Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)

🇨🇳

Wuxi City, Jiangsu, China

Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)

🇨🇳

Hangzhou, Zhejiang, China

Fakultni nemocnice Na Bulovce ( Site 1202)

🇨🇿

Praha 8, Czechia

CHU Bordeaux Haut-Leveque ( Site 0305)

🇫🇷

Pessac, Gironde, France

Institut du Cancer Avignon-Provence ( Site 0306)

🇫🇷

Avignon, Vaucluse, France

Johanniter Krankenhaus Bonn ( Site 1254)

🇩🇪

Bonn, Nordrhein-Westfalen, Germany

Universitätsklinikum Halle ( Site 1251)

🇩🇪

Halle (Saale), Sachsen-Anhalt, Germany

Rabin Medical Center ( Site 0503)

🇮🇱

Petah Tikva, Israel

Sourasky Medical Center ( Site 0502)

🇮🇱

Tel Aviv, Israel

Istituto Clinico Humanitas - Cancer Center ( Site 0555)

🇮🇹

Rozzano, Milano, Italy

IRCCS Casa Sollievo della Sofferenza ( Site 0554)

🇮🇹

San Giovanni Rotondo, Foggia, Italy

ASST Grande Ospedale Metropolitano Niguarda ( Site 0550)

🇮🇹

Milano, Italy

Kindai University Hospital ( Site 0607)

🇯🇵

Osakasayama, Osaka, Japan

Saitama Prefectural Cancer Center ( Site 0603)

🇯🇵

Kitaadachi-gun, Saitama, Japan

Institut Kanser Negara - National Cancer Institute ( Site 1302)

🇲🇾

Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia

Shizuoka Cancer Center ( Site 0605)

🇯🇵

Sunto-gun,, Shizuoka, Japan

Samsung Medical Center ( Site 0651)

🇰🇷

Seoul, Korea, Republic of

Akershus universitetssykehus ( Site 1352)

🇳🇴

Loerenskog, Akershus, Norway

Helse Bergen HF - Haukeland univeritetssykehus ( Site 1353)

🇳🇴

Bergen, Vestfold, Norway

St Olavs Hospital ( Site 1354)

🇳🇴

Trondheim, Sor-Trondelag, Norway

SRBHI of Kirov Region Center of Oncology and medical radiology ( Site 0854)

🇷🇺

Kirov, Kirovskaya Oblast, Russian Federation

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0870)

🇷🇺

Moscow, Moskva, Russian Federation

City Hospital #40 ( Site 0853)

🇷🇺

Saint Petersburg, Sankt-Peterburg, Russian Federation

SHBI "Leningrad Regional Clinical Oncology Dispensary n.a. L.D. Roman"-Clinical Trials Department (

🇷🇺

Sankt-Peterburg, Russian Federation

Clinical Research Center of specialized types medical care-Oncology ( Site 0860)

🇷🇺

Saint-Petersburg, Sankt-Peterburg, Russian Federation

Hospital Universitario Virgen Macarena ( Site 0906)

🇪🇸

Sevilla, Spain

Sandton Oncology Medical Group PTY LTD ( Site 1501)

🇿🇦

Sandton, Gauteng, South Africa

Cancer Care Langenhoven Drive Oncology Centre ( Site 1504)

🇿🇦

Port Elizabeth, Eastern Cape, South Africa

Cancercare Rondebosch Oncology ( Site 1509)

🇿🇦

Rondebosch, Western Cape, South Africa

Hospital Sant Pau i la Santa Creu ( Site 0905)

🇪🇸

Barcelona, Spain

Hospital Universitario 12 de Octubre ( Site 0901)

🇪🇸

Madrid, Spain

Taipei Veterans General Hospital ( Site 0951)

🇨🇳

Taipei, Taiwan

Hacettepe Universitesi Tip Fakultesi ( Site 1003)

🇹🇷

Ankara, Turkey

Ankara Sehir Hastanesi ( Site 1005)

🇹🇷

Ankara, Turkey

Ukrainian Center of Tomotherapy ( Site 1658)

🇺🇦

Kropyvnytskyi, Kirovohradska Oblast, Ukraine

Antalya Egitim ve Arastirma Hastanesi ( Site 1010)

🇹🇷

Antalya, Turkey

Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1657)

🇺🇦

Dnipro, Dnipropetrovska Oblast, Ukraine

MI Precarpathian Clinical Oncology Center ( Site 1654)

🇺🇦

Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine

Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 1052)

🇬🇧

London, London, City Of, United Kingdom

Velindre Cancer Centre ( Site 1058)

🇬🇧

Cardiff, United Kingdom

Leeds Teaching Hospitals NHS Trust ( Site 1050)

🇬🇧

Leeds, United Kingdom

Fakultni nemocnice Olomouc ( Site 1204)

🇨🇿

Olomouc, Czechia

Inova Schar Cancer Institute ( Site 1130)

🇺🇸

Fairfax, Virginia, United States

National Hospital Organization Kyushu Cancer Center ( Site 0609)

🇯🇵

Fukuoka, Japan

The Ottawa Hospital ( Site 0151)

🇨🇦

Ottawa, Ontario, Canada

Norton Cancer Institute ( Site 1139)

🇺🇸

Louisville, Kentucky, United States

MUSC Hollings Cancer Center ( Site 1715)

🇺🇸

Charleston, South Carolina, United States

Policlinico Gemelli di Roma ( Site 0552)

🇮🇹

Roma, Abruzzo, Italy

Cape Town Oncology Trials Pty Ltd ( Site 1506)

🇿🇦

Kraaifontein, Western Cape, South Africa

Oncovida ( Site 0209)

🇨🇱

Santiago, Region M. De Santiago, Chile

Bradfordhill ( Site 0200)

🇨🇱

Santiago, Region M. De Santiago, Chile

University Malaya Medical Centre ( Site 1301)

🇲🇾

Kuala Lumpur, Malaysia

CHU Hotel Dieu Nantes ( Site 0303)

🇫🇷

Nantes, Pays-de-la-Loire, France

Beacon Hospital Sdn Bhd ( Site 1305)

🇲🇾

Petaling Jaya, Selangor, Malaysia

Pantai Hospital Kuala Lumpur ( Site 1303)

🇲🇾

Bangsar, Kuala Lumpur, Malaysia

Universitetssykehuset i Nord Norge. ( Site 1355)

🇳🇴

Tromsoe, Troms, Norway

China Medical University Hospital ( Site 0953)

🇨🇳

Taichung, Taiwan

Odessa Regional Clinical Hospital ( Site 1664)

🇺🇦

Odesa, Odeska Oblast, Ukraine

Clínica Vespucio ( Site 0205)

🇨🇱

Santiago, Region M. De Santiago, Chile

CHU Poitiers ( Site 0304)

🇫🇷

Poitiers, Vienne, France

Chang Gung Medical Foundation - Kaohsiung ( Site 0956)

🇨🇳

Kaohsiung, Changhua, Taiwan

Chang Gung Medical Foundation. Linkou ( Site 0952)

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Taoyuan, Taiwan

National Taiwan University Hospital ( Site 0950)

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Taipei, Taiwan

VCU Health Adult Outpatient Pavillion ( Site 1712)

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Richmond, Virginia, United States

Southern Medical University Nanfang Hospital ( Site 1154)

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Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)

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Guangzhou, Guangdong, China

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