Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
- Registration Number
- NCT04949256
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma.
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- Detailed Description
There will be 2 parts to the study: the cisplatin and 5-fluorouracil (5-FU) (FP) and paclitaxel and cisplatin (TP) Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (FP and TP Safety Run-in), participants will be treated with pembrolizumab plus lenvatinib plus FP or TP. Dose-limiting toxicities, safety, and tolerability will be assessed.
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Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 862
- Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
- Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
- Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab, 30 days after the last dose of lenvatinib, or 180 days after the last dose of chemotherapy, whichever occurs last, and agrees not to donate eggs during this period
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization
- Has adequate organ function
- Has had previous therapy for locally advanced unresectable or metastatic esophageal cancer
- Has locally advanced esophageal carcinoma
- Has metastatic adenocarcinoma of the esophagus
- Has direct invasion into adjacent organs such as the aorta or trachea
- Has radiographic evidence of encasement of a major blood vessel, or of intratumoral cavitation
- Has perforation risks or significant gastrointestinal (GI) bleeding
- Has had clinically significant hemoptysis within 3 weeks prior to the first dose of study drug or tumor bleeding within 2 weeks prior to the first dose of study intervention
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
- Has GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent
- Has had major surgery, open biopsy, or significant traumatic injury within 3 weeks prior to first dose of study interventions
- Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
- Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, or has a history of organ transplant, including allogeneic stem cell transplant
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- 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 is not considered a form of systemic treatment and is allowed
- Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
- Has poorly controlled diarrhea
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Has peripheral neuropathy ≥Grade 2
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B or know active Hepatitis C virus infection
- Has a weight loss of >20% within the last 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Pembrolizumab + Lenvatinib + Chemotherapy Lenvatinib In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 2: Pembrolizumab + Chemotherapy Oxaliplatin Participants receive pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]). Part 2: Pembrolizumab + Chemotherapy 5-FU Participants receive pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]). Part 2: Pembrolizumab + Lenvatinib + Chemotherapy Leucovorin In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 2: Pembrolizumab + Lenvatinib + Chemotherapy Levoleucovorin In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 1: Pembrolizumab + Lenvatinib + Chemotherapy Pembrolizumab In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 1: Pembrolizumab + Lenvatinib + Chemotherapy 5-FU In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 1: Pembrolizumab + Lenvatinib + Chemotherapy Paclitaxel In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 1: Pembrolizumab + Lenvatinib + Chemotherapy Cisplatin In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 2: Pembrolizumab + Lenvatinib + Chemotherapy Pembrolizumab In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 2: Pembrolizumab + Lenvatinib + Chemotherapy Lenvatinib In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 2: Pembrolizumab + Lenvatinib + Chemotherapy Cisplatin In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 2: Pembrolizumab + Lenvatinib + Chemotherapy Oxaliplatin In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 2: Pembrolizumab + Lenvatinib + Chemotherapy 5-FU In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 2: Pembrolizumab + Lenvatinib + Chemotherapy Paclitaxel In the induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks). Part 2: Pembrolizumab + Chemotherapy Pembrolizumab Participants receive pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]). Part 2: Pembrolizumab + Chemotherapy Leucovorin Participants receive pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]). Part 2: Pembrolizumab + Chemotherapy Paclitaxel Participants receive pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]). Part 2: Pembrolizumab + Chemotherapy Levoleucovorin Participants receive pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
- Primary Outcome Measures
Name Time Method Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs) Up to ~21 days Hematologic DLTs are defined as Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Other nonhematologic toxicities considered a DLT include any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting \>3 days (excluding nausea, vomiting, a...
Part 2 (Main Study): Overall Survival (OS) in all Participants Up to ~48 months OS is defined as the time from randomization to death due to any cause. OS in Part 2 for all randomized participants will be presented.
Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs) Up to ~53 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 in Part 1 with AEs will be presented.
Part 1 (FP and TP Safety Run-in): Number of Participants who Discontinued Study Treatment Due to an AE Up to ~53 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 in Part 1 who discontinue study treatment due to an AE will be presented.
- Secondary Outcome Measures
Name Time Method Part 2 (Main Study): ORR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10 Up to ~42 months ORR is defined as the percentage of participants with CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for randomized participants with PD-L1 CPS ≥1...
Part 2 (Main Study): Number of Participants With AEs Up to ~53 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 in Part 2 with AEs will be presented.
Part 2 (Main Study): Change From Baseline in Health-related Quality of life (HRQoL) Score Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Baseline and ~53 months The EORTC QLQ-C30 is a questionnaire to assess the overall HRQoL. Participant responses to the question " How would you rate your overall quality of life (QoL) 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. A higher score indicate...
Part 2 (Main Study): 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) in all Participants Up to ~42 months PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is 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...
Part 2 (Main Study): PFS per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10 Up to ~42 months PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is 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. The appearance of...
Part 2 (Main Study): DOR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10 Up to ~42 months For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of ta...
Part 2 (Main Study): Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR in all Participants Up to ~42 months ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for all ...
Part 2 (Main Study): Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR in all Participants Up to ~42 months For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of ta...
Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 Up to ~48 months OS is defined as the time from randomization to death due to any cause. OS in Part 2 for randomized participants with PD-L1 CPS ≥10 will be presented.
Part 2 (Main Study): Number of Participants who Discontinued Study Treatment Due to an AE Up to ~53 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 in Part 2 who discontinue study treatment due to an AE will be presented.
Part 2 (Main Study): Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18) Baseline and ~53 months The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Using linear transformatio...
Part 2 (Main Study): Time to Deterioration (TTD) in HRQoL Score Using EORTC QLQ-C30 Up to ~ 53 months TTD is defined as the time from baseline to the first onset of a ≥10-point change from baseline in the HRQoL EORTC QLQ-C30 score. The EORTC QLQ-C30 is a questionnaire to assess the overall HRQoL. Participant responses to the question " How would you rate your overall QoL during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A hig...
Part 2 (Main Study): TTD in HRQoL Score Using EORTC QLQ-OES18 Up to ~ 53 months TTD is defined as the time from baseline to the first onset of a ≥10-point change from baseline in the HRQoL EORTC QLQ-OES18 score. The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a f...
Trial Locations
- Locations (195)
PROCLINICAL Pharma ( Site 0904)
🇨🇷San José, San Jose, Costa Rica
Shanxi Provincial Cancer Hospital ( Site 8019)
🇨🇳Taiyuan, Shanxi, China
West China Hospital of Sichuan University ( Site 8048)
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 8035)
🇨🇳Tianjin, Tianjin, China
Sir Run Run Shaw Hospital ( Site 8021)
🇨🇳Hangzhou, Zhejiang, China
ICIMED-Oncology Research Unit ( Site 0903)
🇨🇷San José, San Jose, Costa Rica
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902)
🇨🇷San Jose, Costa Rica
Onco Tech S A ( Site 0901)
🇨🇷San Jose, Costa Rica
Rigshospitalet ( Site 2102)
🇩🇰Copenhagen, Hovedstaden, Denmark
Niigata Cancer Center Hospital ( Site 9022)
🇯🇵Niigata-shi, Niigata, Japan
Kindai University Hospital- Osakasayama Campus ( Site 9017)
🇯🇵Osaka-sayama, Osaka, Japan
Osaka University Hospital ( Site 9021)
🇯🇵Suita, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 9008)
🇯🇵Takatsuki, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 9003)
🇯🇵Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center ( Site 9016)
🇯🇵Nagaizumi, Shizuoka, Japan
Tokyo Metropolitan Komagome Hospital ( Site 9028)
🇯🇵Bunkyo ku, Tokyo, Japan
Toranomon Hospital ( Site 9026)
🇯🇵Minato-ku, Tokyo, Japan
Showa University Hospital ( Site 9025)
🇯🇵Shinagawa, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 9010)
🇯🇵Fukuoka, Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 9027)
🇯🇵Kyoto, Japan
Kyoto University Hospital ( Site 9011)
🇯🇵Kyoto, Japan
Okayama University Hospital ( Site 9024)
🇯🇵Okayama, Japan
Osaka International Cancer Institute ( Site 9009)
🇯🇵Osaka, Japan
Osaka General Medical Center ( Site 9018)
🇯🇵Osaka, Japan
National Cancer Center Hospital ( Site 9001)
🇯🇵Tokyo, Japan
The Cancer Institute Hospital of JFCR ( Site 9005)
🇯🇵Tokyo, Japan
Keio university hospital ( Site 9020)
🇯🇵Tokyo, Japan
Chernihiv Medical Center of Modern Oncology ( Site 1811)
🇺🇦Chernihiv, Chernihivska Oblast, Ukraine
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804)
🇺🇦Kryviy Rih, Dnipropetrovska Oblast, Ukraine
Kharkiv Regional Clinical Oncology Center ( Site 1812)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Medeniyet Universitesi Tip Fakultesi ( Site 1703)
🇹🇷İstanbul, Turkey
Anhui Provincial Cancer Hospital ( Site 8058)
🇨🇳Hefei, Anhui, China
The Affiliated Cancer Hospital of Xinjiang Medical University. ( Site 8041)
🇨🇳Urumqi, Xinjiang, China
City of Hope ( Site 0102)
🇺🇸Duarte, California, United States
MedStar Washington Hospital Center ( Site 0186)
🇺🇸Washington, District of Columbia, United States
James Graham Brown Cancer Center ( Site 0117)
🇺🇸Louisville, Kentucky, United States
Norton Cancer Institute ( Site 0116)
🇺🇸Louisville, Kentucky, United States
Johns Hopkins Bayview Medical Center ( Site 0152)
🇺🇸Baltimore, Maryland, United States
UMASS Memorial Medical Center ( Site 0120)
🇺🇸Worcester, Massachusetts, United States
Capital Health Medical Center - Hopewell ( Site 0189)
🇺🇸Pennington, New Jersey, United States
Hematology-Oncology Associates of CNY ( Site 0173)
🇺🇸East Syracuse, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0132)
🇺🇸New York, New York, United States
Weill Cornell Medical College ( Site 0133)
🇺🇸New York, New York, United States
St. Luke's University Health Network ( Site 0185)
🇺🇸Bethlehem, Pennsylvania, United States
AHN Allegheny General Hospital ( Site 0164)
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 0177)
🇺🇸Charleston, South Carolina, United States
VCU Health Adult Outpatient Pavillion ( Site 0160)
🇺🇸Richmond, Virginia, United States
Seattle Cancer Care Alliance ( Site 0145)
🇺🇸Seattle, Washington, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203)
🇦🇷Berazategui, Buenos Aires, Argentina
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
🇦🇷Caba, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205)
🇦🇷Mar del Plata, Buenos Aires, Argentina
Fundacion Estudios Clinicos-Oncology ( Site 0215)
🇦🇷Rosario, Santa Fe, Argentina
Sanatorio Parque ( Site 0206)
🇦🇷Rosario, Santa Fe, Argentina
Hospital Provincial del Centenario ( Site 0217)
🇦🇷Rosario, Santa Fe, Argentina
Fundacion Favaloro ( Site 0201)
🇦🇷Buenos Aires, Argentina
Fundación Respirar ( Site 0216)
🇦🇷Buenos Aires, Argentina
Hospital Italiano de Córdoba ( Site 0218)
🇦🇷Cordoba, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221)
🇦🇷La Rioja, Argentina
Instituto San Marcos ( Site 0213)
🇦🇷San Juan, Argentina
CancerCare Manitoba ( Site 0001)
🇨🇦Winnipeg, Manitoba, Canada
Princess Margaret Cancer Centre ( Site 0004)
🇨🇦Toronto, Ontario, Canada
Hotel-Dieu de Levis ( Site 0013)
🇨🇦Levis, Quebec, Canada
James Lind Centro de Investigacion del Cancer ( Site 0412)
🇨🇱Temuco, Araucania, Chile
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401)
🇨🇱Temuco, Araucania, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0403)
🇨🇱Santiago, Region M. De Santiago, Chile
Oncovida ( Site 0413)
🇨🇱Santiago, Region M. De Santiago, Chile
Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)
🇨🇱Santiago, Region M. De Santiago, Chile
Bradford Hill Centro de Investigaciones Clinicas ( Site 0404)
🇨🇱Santiago, Region M. De Santiago, Chile
The Second Affiliated Hospital of Anhui Medical University ( Site 8026)
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital ( Site 8001)
🇨🇳Beijing, Beijing, China
Fujian Provincial Cancer Hospital ( Site 8029)
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 8003)
🇨🇳Xiamen City, Fujian Province, Fujian, China
Zhongshan Hospital Affiliated to Xiamen University ( Site 8055)
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 8047)
🇨🇳Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 8031)
🇨🇳Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University ( Site 8046)
🇨🇳Changsha, Hainan, China
The First Affiliated Hospital of Hainan Medical University ( Site 8042)
🇨🇳Haikou, Hainan, China
Affiliated Hospital of Chengde Medical Univeristy ( Site 8053)
🇨🇳Chengde, Hebei, China
Harbin Medical University Cancer Hospital ( Site 8009)
🇨🇳Harbin, Heilongjiang, China
Anyang Cancer Hospital ( Site 8006)
🇨🇳Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036)
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University ( Site 8018)
🇨🇳Xinxiang, Henan, China
Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025)
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 8014)
🇨🇳Wuhan, Hubei, China
Affiliated hospital of Jiangnan university ( Site 8049)
🇨🇳Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University ( Site 8015)
🇨🇳Xuzhou, Jiangsu, China
Jilin Cancer Hospital ( Site 8016)
🇨🇳Changchun, Jilin, China
Jinan Central Hospital ( Site 8052)
🇨🇳Jinan, Shandong, China
Shandong Cancer Hospital ( Site 8060)
🇨🇳Jinan, Shandong, China
Affiliated Hospital of Jining Medical University ( Site 8017)
🇨🇳Jining, Shandong, China
Linyi Cancer Hospital- Medical Oncology Department ( Site 8051)
🇨🇳Linyi, Shandong, China
Odense University Hospital ( Site 2101)
🇩🇰Odense, Syddanmark, Denmark
Institut De Cancerologie De Lorraine ( Site 1010)
🇫🇷Vandoeuvre les Nancy, Ain, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014)
🇫🇷Strasbourg, Alsace, France
Centre François Baclesse ( Site 1009)
🇫🇷Caen, Calvados, France
Centre Georges Francois Leclerc ( Site 1008)
🇫🇷Dijon, Cote-d Or, France
C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( S
🇫🇷Brest, Finistere, France
CHU Besançon ( Site 1015)
🇫🇷Besançon, Franche-Comte, France
CHU Bordeaux Haut-Leveque ( Site 1012)
🇫🇷Pessac, Gironde, France
Institut du Cancer de Montpellier ( Site 1002)
🇫🇷Montpellier, Herault, France
CHRU de Tours - Hopital Bretonneau ( Site 1018)
🇫🇷Tours, Indre-et-Loire, France
Institut De Cancerologie De L Ouest ( Site 1003)
🇫🇷Saint Herblain, Loire-Atlantique, France
Hôpital Claude Huriez ( Site 1030)
🇫🇷Lille, Nord, France
Hopital Henri Mondor ( Site 1007)
🇫🇷Creteil, Val-de-Marne, France
Hopital Saint Louis ( Site 1029)
🇫🇷Paris, France
Centro Regional de Sub Especialidades Medicas SA ( Site 0604)
🇬🇹Guatemala, Quetzaltenango, Guatemala
MEDI-K ( Site 0601)
🇬🇹Guatemala, Guatemala
Oncomedica ( Site 0602)
🇬🇹Guatemala, Guatemala
Soluciones Gastrointestinales S.A. ( Site 0607)
🇬🇹Guatemala, Guatemala
Queen Mary Hospital ( Site 4001)
🇭🇰Hong Kong, Hong Kong
Queen Elizabeth Hospital. ( Site 4004)
🇭🇰Kowloon, Hong Kong
Pecsi Tudomanyegyetem AOK ( Site 1204)
🇭🇺Pecs, Baranya, Hungary
Petz Aladar Egyetemi Oktato Korhaz ( Site 1210)
🇭🇺Gyor, Gyor-Moson-Sopron, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203)
🇭🇺Szolnok, Jasz-Nagykun-Szolnok, Hungary
Orszagos Onkologiai Intezet ( Site 1207)
🇭🇺Budapest, Hungary
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313)
🇮🇹Meldola, Emilia-Romagna, Italy
A.O.U. Santa Maria della Misericordia di Udine ( Site 1302)
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Humanitas Research Hospital ( Site 1309)
🇮🇹Rozzano, Lombardia, Italy
Azienda Ospedaliera Universitaria Pisana ( Site 1312)
🇮🇹Pisa, Toscana, Italy
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 1311)
🇮🇹Padova, Veneto, Italy
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314)
🇮🇹Catanzaro, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 1301)
🇮🇹Firenze, Italy
IRCCS Ospedale San Raffaele di Milano ( Site 1304)
🇮🇹Milano, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306)
🇮🇹Milano, Italy
A.O. Universitaria di Modena ( Site 1307)
🇮🇹Modena, Italy
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305)
🇮🇹Napoli, Italy
Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310)
🇮🇹Roma, Italy
Aichi Cancer Center Hospital ( Site 9006)
🇯🇵Nagoya, Aichi, Japan
Chiba cancer center ( Site 9023)
🇯🇵Chiba-shi, Chiba, Japan
National Cancer Center Hospital East ( Site 9002)
🇯🇵Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 9019)
🇯🇵Matsuyama, Ehime, Japan
Hyogo Cancer Center ( Site 9014)
🇯🇵Akashi, Hyogo, Japan
Ibaraki Prefectural Central Hospital ( Site 9007)
🇯🇵Kasama, Ibaraki, Japan
Kagawa University Hospital ( Site 9015)
🇯🇵Kita-gun, Kagawa, Japan
Kanagawa Cancer Center ( Site 9004)
🇯🇵Yokohama, Kanagawa, Japan
Tohoku University Hospital ( Site 9013)
🇯🇵Sendai-shi, Miyagi, Japan
Seoul National University Bundang Hospital ( Site 5006)
🇰🇷Seongnam-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 5002)
🇰🇷Songpagu, Seoul, Korea, Republic of
Severance Hospital ( Site 5003)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center ( Site 5005)
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital ( Site 5001)
🇰🇷Seoul, Korea, Republic of
University Malaya Medical Centre ( Site 9101)
🇲🇾Lembah Pantai, Kuala Lumpur, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 9100)
🇲🇾Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur ( Site 9104)
🇲🇾Kuala Lumpur, Malaysia
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2201)
🇷🇴Bucharest, Bucuresti, Romania
Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2207)
🇷🇴Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL ( Site 2202)
🇷🇴Comuna Floresti, Cluj, Romania
Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203)
🇷🇴Ovidiu, Constanta, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204)
🇷🇴Craiova, Dolj, Romania
Policlinica Oncomed SRL ( Site 2206)
🇷🇴Timisoara, Timis, Romania
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
🇷🇺Ufa, Baskortostan, Respublika, Russian Federation
GBUZ LOKB ( Site 1502)
🇷🇺Saint-Petersburg, Leningradskaya Oblast, Russian Federation
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510)
🇷🇺Moscow, Moskva, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519)
🇷🇺Saint-Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 150
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520)
🇷🇺Tyumen, Tyumenskaya Oblast, Russian Federation
National Cancer Centre Singapore ( Site 9201)
🇸🇬Singapore, Central Singapore, Singapore
Wits Clinical Research ( Site 9502)
🇿🇦Johannesburg, Gauteng, South Africa
The Oncology Centre ( Site 9505)
🇿🇦Durban, Kwazulu-Natal, South Africa
Hospital Universitario General de Asturias ( Site 1601)
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Marques de Valdecilla ( Site 1602)
🇪🇸Santander, Cantabria, Spain
Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609)
🇪🇸Ourense, Orense, Spain
Hospital General Universitari Vall d Hebron ( Site 1607)
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Maranon ( Site 1604)
🇪🇸Madrid, Spain
Hospital Virgen del Rocio ( Site 1606)
🇪🇸Sevilla, Spain
Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007)
🇨🇳Tainan City, Tainan, Taiwan
Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005)
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital ( Site 6003)
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital ( Site 6004)
🇨🇳Tainan, Taiwan
National Taiwan University Hospital ( Site 6001)
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital ( Site 6006)
🇨🇳Taipei, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 7002)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Songklanagarind hospital ( Site 7001)
🇹🇭HatYai, Songkhla, Thailand
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1714)
🇹🇷Adana, Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701)
🇹🇷Ankara, Turkey
Memorial Ankara Hastanesi ( Site 1702)
🇹🇷Ankara, Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1715)
🇹🇷Ankara, Turkey
Atatürk Üniversitesi-onkoloji ( Site 1712)
🇹🇷Erzurum, Turkey
Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 1716)
🇹🇷Istanbul, Turkey
Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711)
🇹🇷Istanbul, Turkey
Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
🇺🇦Antonivka Village, Khersonska Oblast, Ukraine
SNPE National Cancer Institute ( Site 1806)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Podillya Regional Center of Oncology ( Site 1809)
🇺🇦Vinnytsia, Vinnytska Oblast, Ukraine
Volyn Regional Oncological Dispensary ( Site 1816)
🇺🇦Lutsk, Volynska Oblast, Ukraine
Cambridge University Hospitals NHSFT ( Site 1908)
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Ninewells Hospital and Medical School ( Site 1907)
🇬🇧Dundee, Dundee City, United Kingdom
Nottingham University Hospital NHS Trust ( Site 1910)
🇬🇧Nottingham, England, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915)
🇬🇧London, London, City Of, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 1901)
🇬🇧London, London, City Of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1905)
🇬🇧London, London, City Of, United Kingdom
Royal Marsden NHS Trust. ( Site 1906)
🇬🇧Sutton, London, City Of, United Kingdom
Western General Hospital ( Site 1912)
🇬🇧Edinburgh, Midlothian, United Kingdom
The Christie NHS Foundation Trust ( Site 1909)
🇬🇧Manchester, United Kingdom