Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

Phase 3

Completed

Conditions: Cervical Cancer

Interventions: Biological: Pembrolizumab
Drug: Paclitaxel
Drug: Cisplatin
Drug: Carboplatin
Drug: Placebo to pembrolizumab
Biological: Bevacizumab

Registration Number: NCT03635567

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.

The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 617

Inclusion Criteria

Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). Prior chemotherapy utilized as a radiosensitizing agent and completed at least 2 weeks prior to randomization with resolution of all treatment-related toxicities is allowed. AEs due to previous treatments should be resolved to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are eligible.
Not pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab
Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization
Has adequate organ function

Exclusion Criteria

A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have undergone potentially curative therapy are not excluded.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses 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 that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137)
Has received prior systemic chemotherapy for treatment of cervical cancer.
Has not recovered adequately from toxicity and/or complications from major surgery prior to randomization
Has received prior radiotherapy within 2 weeks prior to randomization. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Has received a live vaccine within 30 days prior to randomization
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab
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
Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days following last dose of pembrolizumab/placebo and 210 days following last dose of chemotherapy/bevacizumab
Has had an allogeneic tissue/solid organ transplant

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo+Chemotherapy	Placebo to pembrolizumab	On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Pembrolizumab+Chemotherapy	Pembrolizumab	On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Pembrolizumab+Chemotherapy	Bevacizumab	On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Placebo+Chemotherapy	Bevacizumab	On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Pembrolizumab+Chemotherapy	Carboplatin	On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Pembrolizumab+Chemotherapy	Paclitaxel	On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Pembrolizumab+Chemotherapy	Cisplatin	On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Placebo+Chemotherapy	Paclitaxel	On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Placebo+Chemotherapy	Cisplatin	On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
Placebo+Chemotherapy	Carboplatin	On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.

Primary Outcome Measures

Name	Time	Method
OS in All Participants	Up to approximately 46 months	OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants is presented.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1	Up to approximately 46 months	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥1 is presented.
Overall Survival (OS) in Participants With PD-L1 CPS ≥1	Up to approximately 46 months	OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥1 is presented.
OS in Participants With PD-L1 CPS ≥10	Up to approximately 46 months	OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥10 is presented.
PFS Per RECIST 1.1 as Assessed by Investigator in All Participants	Up to approximately 46 months	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.
PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10	Up to approximately 46 months	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥10 is presented.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants That Were PFS Event-Free (PFS Rate) at Month 12 Per RECIST 1.1 as Assessed by Investigator	12 months	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS Rate was defined as the percentage of participants that were PFS event-free at Month 12. The PFS Rate per RECIST 1.1 as assessed by Investigator at Month 12 is presented.
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator	Up to approximately 46 months	ORR was defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by Investigator is presented.
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator	Up to approximately 46 months	For participants who demonstrate CR or PR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator is presented.
PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR)	Up to approximately 46 months	PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by BICR is presented.
Number of Participants Who Experienced a Serious AE (SAE)	Up to approximately 46 months	An SAE was defined as any untoward medical occurrence that, at any dose: a.) Resulted in death; b.) Was life-threatening; c.) Required inpatient hospitalization or prolongation of existing hospitalization; d.) Resulted in persistent or significant disability/incapacity; e.) Was a congenital anomaly/birth defect; f.) Other important medical events; h.) Was a new cancer (that is not a condition of the study) or i.) Was associated with an overdose. The number of participants who experienced an SAE is presented.
Number of Participants Who Discontinued Study Treatment Due to an AE	Up to approximately 43 months	The number of participants who discontinued study treatment due to an AE is presented.
Number of Participants Who Experienced an Adverse Event (AE)	Up to approximately 46 months	An AE was 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 experienced an AE is presented.
Number of Participants Who Experienced an Immune-related AE (irAE)	Up to approximately 46 months	AEs associated with pembrolizumab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. For this study irAEs included, but were not limited to: -Pneumonitis; * Diarrhea/Colitis; * Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin; * Type 1 diabetes mellitus or Hyperglycemia; * Hypophysitis; * Hyperthyroidism; * Hypothyroidism; * Nephritis and Renal dysfunction; and * Myocarditis. The number of participants who experienced an irAE is presented.
Number of Participants With a 10-point Change From Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Combined Global Score	Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months	The EORTC QLQ-C30 is a questionnaire to assess the quality of life of cancer patients. Participant responses to "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) are scored on a 7-point scale (1= Very poor to 7=Excellent). Raw scores are standardized with linear transformation so that scores range from 0-100. A higher combined score indicates a better overall health status. Participant post-baseline scores were classified based on change from baseline, "Improved": a ≥10-point improvement in score and confirmed by the next visit; "Stable": a ≥10-point increase or \<10-point change in score OR a \<10-point change in score and a ≥10-point increase in score at the next visit; or "Deteriorated": a ≥10-point deterioration in score when the criteria for improvement/stability weren't met. Participants who didn't meet "Improved", "Stable", or "Deteriorated" criteria reported as "Other".

Trial Locations

Locations (149): Monash Health-Monash Medical Centre ( Site 1519)
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Clayton, Australia
Seattle Cancer Care Alliance ( Site 1777)
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Seattle, Washington, United States
Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)
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Sunto-gun, Shizuoka, Japan
Centro Medico Monte Carmelo ( Site 1156)
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Arequipa, Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)
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Lima, Peru
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157)
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Lima, Peru
National Research Ogarev Mordovia State University ( Site 1347)
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Saransk, Russian Federation
Fundacion Arturo Lopez Perez FALP ( Site 1061)
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Santiago, Chile
Instituto Nacional de Cancerologia E.S.E ( Site 1095)
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Bogota, Cundinamarca, Colombia
Hemato Oncologos S.A. ( Site 1100)
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Cali, Valle, Colombia
Rambam Medical Center ( Site 1364)
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Haifa, Israel
Shaare Zedek Medical Center ( Site 1366)
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Jerusalem, Israel
Instituto Nacional de Cancerologia. ( Site 1130)
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Mexico, Mexico
Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)
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Lima, Peru
China Medical University Hospital ( Site 1635)
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Taichung, Taiwan
Hacettepe University Medical Faculty ( Site 1459)
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Ankara, Turkey
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456)
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Izmir, Turkey
City Clinical Hosp.4 of DCC ( Site 1482)
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Dnipropetrovsk, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489)
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Kharkiv, Ukraine
Texas Oncology-San Antonio Medical Center ( Site 8001)
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San Antonio, Texas, United States
Barbara Ann Karmanos Cancer Institute ( Site 1785)
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Detroit, Michigan, United States
Henry Ford Health System ( Site 1810)
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Detroit, Michigan, United States
Washington University School of Medicine ( Site 1779)
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Saint Louis, Missouri, United States
H. Lee Moffitt Cancer Center and Research Institute ( Site 1754)
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Tampa, Florida, United States
OSU Wexner Medical Center ( Site 1817)
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Hilliard, Ohio, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006)
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Berazategui, Buenos Aires, Argentina
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768)
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Tulsa, Oklahoma, United States
Columbia University Medical Center ( Site 1800)
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New York, New York, United States
Instituto Medico Especializado Alexander Fleming ( Site 1009)
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Buenos Aires, Argentina
Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)
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South Brisbane, Queensland, Australia
BC Cancer - Vancouver Center ( Site 1722)
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Vancouver, British Columbia, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)
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Quebec, Canada
Princess Margaret Cancer Centre ( Site 1732)
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Toronto, Ontario, Canada
CancerCare Manitoba ( Site 1725)
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Winnipeg, Manitoba, Canada
Sunnybrook Research Institute ( Site 1733)
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Toronto, Ontario, Canada
Instituto Clinico Oncologico del Sur ( Site 1062)
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Temuco, Chile
Institut Paoli Calmettes ( Site 1182)
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Marseille, France
Instituto Cancerologico de Narino Ltda ( Site 1097)
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Pasto, Colombia
Centre Eugene Marquis ( Site 1187)
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Rennes, France
Institut Curie - Centre Rene Huguenin ( Site 1185)
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Saint-Cloud, France
Oncomedica S.A. ( Site 1098)
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Monteria, Colombia
Centre Jean Perrin ( Site 1181)
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Clermont Ferrand, France
Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)
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Paris, France
Universitaetsklinikum Carl Gustav Carus ( Site 1211)
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Dresden, Germany
Universitatsklinikum Essen AoR ( Site 1213)
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Essen, Germany
Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)
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Hannover, Germany
Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243)
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Aviano, Italy
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245)
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Bolgna, Italy
Hadassah Medical Center. Ein Kerem ( Site 1367)
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Jerusalem, Israel
National Cancer Center Hospital East ( Site 1704)
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Kashiwa, Chiba, Japan
Asan Medical Center ( Site 1601)
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Seoul, Korea, Republic of
Universitaet Regensburg ( Site 1221)
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Regensburg, Germany
Istituto Nazionale Tumori ( Site 1251)
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Milano, Italy
Istituto Europeo di Oncologia ( Site 1250)
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Milano, Italy
Soroka Medical Center ( Site 1363)
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Beer-Sheva, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)
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Napoli, Italy
Policlinico Universitario -Agostino Gemelli ( Site 1241)
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Roma, Italy
The Jikei University Hospital ( Site 1697)
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Tokyo, Japan
Samsung Medical Center ( Site 1604)
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Seoul, Korea, Republic of
Seoul National University Hospital ( Site 1602)
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Seoul, Korea, Republic of
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)
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Doniostia - San Sebastian, Guipuzcoa, Spain
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334)
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Moscow, Russian Federation
Hospital Nacional Maria Auxiliadora ( Site 1155)
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Lima, Peru
Municipal Clinical Oncology Center ( Site 1346)
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Saint Petersburg, Russian Federation
Hospital Quiron Madrid ( Site 1277)
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Pozuelo de Alarcon, Madrid, Spain
MD Anderson Cancer Center Madrid ( Site 1273)
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Madrid, Spain
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276)
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Badalona, Spain
MI Odessa Regional Oncological Centre ( Site 1493)
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Odesa, Ukraine
Universitaetsklinikum Duesseldorf ( Site 1220)
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Duesseldorf, Germany
Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)
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Muenchen, Germany
Klinikum Oldenburg AoeR ( Site 1218)
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Oldenburg, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)
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Kiel, Germany
University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784)
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Oklahoma City, Oklahoma, United States
UC Irvine Health ( Site 1796)
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Orange, California, United States
Georgia Cancer Center at Augusta University ( Site 1767)
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Augusta, Georgia, United States
Mount Sinai Chelsea ( Site 1760)
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New York, New York, United States
Holy Name Medical Center ( Site 1776)
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Teaneck, New Jersey, United States
Hospital de Oncologia Angel Roffo ( Site 1003)
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Buenos Aires, Argentina
MUSC Hollings Cancer Center ( Site 1819)
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Charleston, South Carolina, United States
West Cancer Center - East Campus ( Site 1763)
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Germantown, Tennessee, United States
Hospital Aleman ( Site 1005)
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Buenos Aires, Argentina
Flinders Medical Centre ( Site 1513)
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Bedford Park, South Australia, Australia
Royal North Shore Hospital ( Site 1514)
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St Leonards, New South Wales, Australia
London Regional Cancer Program - London HSC ( Site 1723)
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London, Ontario, Canada
Juravinski Cancer Centre ( Site 1735)
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Hamilton, Ontario, Canada
The Ottawa Hospital Cancer Centre ( Site 1736)
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Ottawa, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)
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Montreal, Quebec, Canada
Universitatsklinikum Hamburg-Eppendorf ( Site 1212)
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Hamburg, Germany
Sourasky Medical Center ( Site 1362)
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Tel Aviv, Israel
The Jikei University Kashiwa Hospital ( Site 1701)
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Kashiwa, Chiba, Japan
University of the Ryukyus Hospital ( Site 1706)
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Nakagami-gun, Okinawa, Japan
Consultorio de Medicina Especializada del Sector Privado ( Site 1129)
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Ciudad de Mexico, Mexico
Keimyung University Dongsan Medical Center ( Site 1603)
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Daegu, Korea, Republic of
Medical Care and Research S.A. de C.V. ( Site 1135)
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Merida, Yucatan, Mexico
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)
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Kazan, Russian Federation
Hospital Universitario Virgen Macarena ( Site 1274)
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Sevilla, Spain
Taichung Veterans General Hospital ( Site 1634)
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Taichung, Taiwan
Taipei Veterans General Hospital ( Site 1631)
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Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636)
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Taipei, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 1633)
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Taoyuan, Taiwan
National Cancer Institute of the MoH of Ukraine ( Site 1484)
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Kyiv, Ukraine
Cancer Institute of New Jersey at University Hospital ( Site 1762)
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Newark, New Jersey, United States
Centro Oncologico Riojano Integral ( Site 1004)
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La Rioja, Argentina
Sociedad Oncovida S.A. ( Site 1069)
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Santiago, Chile
Ehime University Hospital ( Site 1693)
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Toon, Ehime, Japan
Kurume University Hospital ( Site 1692)
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Kurume, Fukuoka, Japan
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127)
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Ciudad de Mexico, Mexico
Tomsk Scientific Research Institute of Oncology ( Site 1360)
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Tomsk, Russian Federation
Alaska Women's Cancer Care ( Site 1770)
🇺🇸
Anchorage, Alaska, United States
Smilow Cancer Hospital at Yale New Haven ( Site 1809)
🇺🇸
New Haven, Connecticut, United States
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152)
🇵🇪
Trujillo, La Libertad, Peru
Medical Rehabilitation Center ( Site 1337)
🇷🇺
Moscow, Russian Federation
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)
🇨🇦
Montreal, Quebec, Canada
Oncocentro ( Site 1065)
🇨🇱
Vina del Mar, Valparaiso, Chile
Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)
🇨🇱
Santiago, Chile
Arizona Oncology Associates, PC- HAL ( Site 8005)
🇺🇸
Phoenix, Arizona, United States
Tom Baker Cancer Centre ( Site 1728)
🇨🇦
Calgary, Alberta, Canada
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)
🇨🇦
Kelowna, British Columbia, Canada
Centro Medico San Roque ( Site 1001)
🇦🇷
Tucuman, Argentina
CIUSSS du Saguenay-Lac-St-Jean ( Site 1729)
🇨🇦
Chicoutimi, Quebec, Canada
Biomelab S A S ( Site 1104)
🇨🇴
Barranquilla, Colombia
Rabin Medical Center ( Site 1365)
🇮🇱
Petah Tikva, Israel
Chaim Sheba Medical Center ( Site 1361)
🇮🇱
Ramat Gan, Israel
National Hospital Organization Hokkaido Cancer Center ( Site 1700)
🇯🇵
Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 1705)
🇯🇵
Akashi, Hyogo, Japan
Iwate Medical University Hospital ( Site 1695)
🇯🇵
Shiwa-gun, Iwate, Japan
Centro Estatal de Cancerologia de Chihuahua ( Site 1123)
🇲🇽
Chihuahua, Mexico
Faicic S de RL de CV ( Site 1133)
🇲🇽
Veracruz, Mexico
Kaohsiung Veterans General Hospital ( Site 1632)
🇨🇳
Kaohsiung, Taiwan
Queen Elizabeth II Health Sciences Centre ( Site 1731)
🇨🇦
Halifax, Nova Scotia, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)
🇨🇦
Sherbrooke, Quebec, Canada
Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103)
🇨🇴
Valledupar, Cesar, Colombia
Saitama Medical University International Medical Center ( Site 1691)
🇯🇵
Hidaka, Saitama, Japan
National Cancer Center Hospital ( Site 1702)
🇯🇵
Tokyo, Japan
The Cancer Institute Hospital of JFCR ( Site 1698)
🇯🇵
Tokyo, Japan
Keio University Hospital ( Site 1699)
🇯🇵
Tokyo, Japan
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125)
🇲🇽
San Pedro Garza Garcia, Mexico
Hospital Nacional Arzobispo Loayza ( Site 1159)
🇵🇪
Lima, Peru
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345)
🇷🇺
Ufa, Russian Federation
Baskent Universitesi Ankara Hastanesi ( Site 1451)
🇹🇷
Ankara, Turkey
Akdeniz Universitesi Tip Fakultesi ( Site 1453)
🇹🇷
Antalya, Turkey
Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)
🇷🇺
Novosibirsk, Russian Federation
Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458)
🇹🇷
Istanbul, Turkey
Medical Centre LLC Oncolife ( Site 1485)
🇺🇦
Zaporizhzhya, Ukraine
National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348)
🇷🇺
St. Petersburg, Russian Federation
Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457)
🇹🇷
Adana, Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)
🇹🇷
Konya, Turkey
MI Precarpathian Clinical Oncology Center ( Site 1487)
🇺🇦
Ivano-Frankivsk, Ukraine
St John of God Subiaco Hospital ( Site 1512)
🇦🇺
Subiaco, Western Australia, Australia

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