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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02603432
Registration number
NCT02603432
Ethics application status
Date submitted
9/11/2015
Date registered
11/11/2015
Date last updated
27/03/2024
Titles & IDs
Public title
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
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Scientific title
A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY
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Secondary ID [1]
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2015-003262-86
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Secondary ID [2]
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B9991001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Avelumab
Other interventions - Best Supportive Care
Other interventions - Following the planned interim analysis for this study: Avelumab
Experimental: Arm A - Avelumab plus Best Supportive Care (BSC)
Other: Arm B - Best Supportive Care (BSC) alone
Following the planned interim analysis for this study, eligible patients in Arm B whose cancer has not worsened and are still in the "watch and wait" part of the study will be given the option to receive Avelumab plus BSC. Prior to this, Arm B patients received BSC alone. All patients who choose not to receive Avelumab will be discontinued.
Other interventions: Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
Other interventions: Best Supportive Care
BSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.
Other interventions: Following the planned interim analysis for this study: Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
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Timepoint [1]
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From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
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Secondary outcome [1]
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Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [1]
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BICR assessed PFS: Duration from randomization until disease progression (PD) or death. PD as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.
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Timepoint [1]
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From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
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Secondary outcome [2]
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Progression-Free Survival (PFS) as Assessed by Investigator
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Assessment method [2]
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Investigator assessed PFS: Duration from randomization to first documentation of PD or death, whichever occurred first. PD as per RECIST version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started a new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.
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Timepoint [2]
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From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
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Secondary outcome [3]
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Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [3]
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BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
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Timepoint [3]
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From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)
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Secondary outcome [4]
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Percentage of Participants With Objective Response as Assessed by Investigator
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Assessment method [4]
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Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
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Timepoint [4]
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From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)
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Secondary outcome [5]
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Time to Tumor Response (TTR) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [5]
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TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR), which was confirmed subsequently. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
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Timepoint [5]
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From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
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Secondary outcome [6]
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Time to Tumor Response (TTR) as Assessed by Investigator
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Assessment method [6]
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TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.
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Timepoint [6]
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From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
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Secondary outcome [7]
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Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [7]
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BICR assessed DOR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR: complete disappearance of all target and non-target lesions, with exception of nodal disease sustained for 4 weeks. Any pathological lymph nodes reduced in short axis to <10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD for target disease: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study and relative increase of 20%, sum also demonstrated absolute increase of at least 5 mm. PD for non-target disease: unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD.
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Timepoint [7]
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First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months)
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Secondary outcome [8]
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Duration of Response (DOR) as Assessed by Investigator
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Assessment method [8]
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Investigator assessed DOR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR: complete disappearance of all target and non-target lesions, with exception of nodal disease sustained for 4 weeks. Additionally, normalization of tumor marker levels and any pathological lymph nodes reduced in short axis to <10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD for target disease: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study and relative increase of 20%, sum also demonstrated absolute increase of at least 5 mm. PD for non-target disease: unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD.
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Timepoint [8]
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First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months)
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Secondary outcome [9]
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Percentage of Participants With Disease Control (DC) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [9]
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Disease Control (DC) was defined as a best overall response of CR, PR, non-CR/non-PD or stable disease (SD) as assessed by BICR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds.
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Timepoint [9]
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From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)
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Secondary outcome [10]
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Percentage of Participants With Disease Control (DC) as Assessed by Investigator
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Assessment method [10]
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DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD as assessed by Investigator. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Additionally, normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds.
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Timepoint [10]
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From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)
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Secondary outcome [11]
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Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
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Assessment method [11]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent AEs are events between first dose of study drug and up to 90 days after last dose of study drug or end of treatment (EOT) visit, that were absent before treatment or that worsened relative to pretreatment state.
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Timepoint [11]
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For "Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)
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Secondary outcome [12]
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Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3 (G3), Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
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Assessment method [12]
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Hematology (Anemia G3: hemoglobin<8.0 grams per deciliter [g/dL],<4.9 millimoles (mmol)/liter (L),<80 g/L, transfusion indicated, Grade 4 [G4]: life-threatening consequences, urgent intervention indicated, Grade 5 [G5]: death; platelet count decreased-G3:<50.0 to 25.0*10^9/L, G4: <25.0*10^9/L; lymphocyte count decreased-G3:<0.5-0.2*10^9/L, G4:<0.2*10^9/L; neutrophil count decreased-G3:<1.0 to 0.5*10^9 /L, G4:<0.5*10^9/L). Chemistry (creatinine increased-G3:>3.0 to 6.0*upper limit of normal [ULN], G4:>6.0*ULN; serum amylase increased, lipase increased-G3:>2.0- 5.0*ULN, G4:>5.0*ULN. Aspartate aminotransferase [AST], alanine aminotransferase [ALT]-G3:>5.0 to 20.0*ULN, G4:>20.0*ULN]. Blood bilirubin increased-[G3:>3.0 to 10.0*ULN, G4:>10.0*ULN], Creatine phosphokinase [CPK] increased- [G3:>5.0 to 10.0*ULN, G4:>10.0*ULN], Hyperglycemia-[G3:>250 to 500 mg/dL; >13.9 to 27.8 mmol/L hospitalization indicated, G4:>500 mg/DL; >27.8 mmol/L life-threatening consequences]).
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Timepoint [12]
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For "Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)
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Secondary outcome [13]
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Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit
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Assessment method [13]
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Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP).
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Timepoint [13]
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Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)
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Secondary outcome [14]
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Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit
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Assessment method [14]
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Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.
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Timepoint [14]
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Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)
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Secondary outcome [15]
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Maximum Plasma Concentration (Cmax) of Avelumab
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Assessment method [15]
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The Lower Limit of Quantitation (LLQ) of avelumab was 0.20 micrograms (mcg)/milliliter (mL). Data for this outcome measure was not collected for reporting group "Best Supportive Care", since avelumab was not administered in this arm.
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Timepoint [15]
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End of avelumab infusion on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)
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Secondary outcome [16]
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Predose Plasma Concentration (Ctrough) of Avelumab
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Assessment method [16]
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The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not collected for reporting group "Best Supportive Care", since avelumab was not administered in this arm.
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Timepoint [16]
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Pre-dose (0 hour) on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)
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Secondary outcome [17]
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Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
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Assessment method [17]
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ADA against avelumab in serum samples was determined and reported separately for ADA never positive and ADA ever positive participants. Participants were considered ADA ever-positive if they had at least one positive ADA result at any time point during study and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Best Supportive Care", since avelumab was not administered in this arm.
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Timepoint [17]
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From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
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Secondary outcome [18]
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Number of ADA Ever Positive Participants For Each Serum of ADA Titers for Avelumab
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Assessment method [18]
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Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum of ADA titer (60, 180, 540, 1620, 4860, 14580, and 131220) are reported.
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Timepoint [18]
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From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
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Secondary outcome [19]
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Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never Positive and Ever Positive Status
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Assessment method [19]
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nAb against avelumab in serum samples was determined and reported separately for nAb never positive and nAb ever positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb result at any time point during study and were otherwise considered negative.
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Timepoint [19]
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From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
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Secondary outcome [20]
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Number of Participants With Programmed Death Receptor-1 Ligand 1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
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Assessment method [20]
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PD-L1 assessment was performed using immunohistochemistry on pre-treatment tumor tissue samples. Participants were classified as having PD-L1 -positive status if at least one of the following three criteria were met: at least 25% of tumor cells stained for PD-L1, at least 25% of immune cells stained for PD-L1 if more than 1% of the tumor area contained immune cells, or 100% of immune cells stained for PD-L1 if no more than 1% of the tumor area contained immune cells.
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Timepoint [20]
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Up to 41 months at the time of the analysis
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Secondary outcome [21]
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Number of Participants With Cluster of Differentiation 8 (CD8) T Lymphocytes (Cytotoxic T Lymphocytes)
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Assessment method [21]
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Number of Participants With CD8 T Lymphocytes (Cytotoxic T lymphocytes) were presented in this outcome.
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Timepoint [21]
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Up to approximately 60 months
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Secondary outcome [22]
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Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Score at Day 1 of Cycle 6
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Assessment method [22]
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NCCN-FACT FBlSI-18 is an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms- physical subscale with 9 items, disease related symptoms- emotional subscale with 2 items, treatment side effects subscale with 5 items and general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging from 0=not at all to 4=very much. Items that were negatively framed, and the scores were reversed for analysis so that higher scores= good quality of life. Overall score: total of 18 items, ranging from 0=severely symptomatic to 72=asymptomatic. Higher scores= better functioning or lower symptom burden.
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Timepoint [22]
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Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
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Secondary outcome [23]
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Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores
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Assessment method [23]
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NCCN-FACT FBlSI-18: an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging: 0=not at all to 4=very much. For items negatively framed, scores were reversed for analysis so that higher scores= good quality of life. DRS-P score: total 9 items, ranging from 0=severely symptomatic to 36= asymptomatic. Higher scores=better functioning or lower symptom burden. TTD: time from randomization to first time participant's score showed 3 point or greater decrease from baseline in FBlSI-DRS-P subscale for 2 consecutive assessments.
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Timepoint [23]
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From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)
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Secondary outcome [24]
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Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6
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Assessment method [24]
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The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published UK weights was used to create a single summary utility score. Utility scores range from -0.594 to 1, with low scores representing lower health status.
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Timepoint [24]
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Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
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Secondary outcome [25]
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Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6
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Assessment method [25]
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The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
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Timepoint [25]
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Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
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Eligibility
Key inclusion criteria
- Histologically confirmed, unresectable locally advanced or metastatic transitional
cell carcinoma of the urothelium
- Stage IV disease at the start of first-line chemotherapy
- Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy
- Prior first-line chemotherapy must have consisted of at least 4 cycles and no more
than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin
- No evidence of progressive disease following completion of first-line chemotherapy
(i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
- Prior immunotherapy with IL-2, IFN-a, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug
specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however,
alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse
events not constituting a safety risk based on the investigator's judgement are
acceptable.
- Patients with known symptomatic central nervous system (CNS) metastases requiring
steroids
- Diagnosis of any other malignancy within 5 years prior to randomization, except for
adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the
breast or of the cervix, low grade prostate cancer on surveillance without any plans
for treatment intervention, or prostate cancer that has been adequately treated with
prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/03/2023
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Sample size
Target
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Accrual to date
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Final
700
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Chris O'Brien Lifehouse - Camperdown
Query!
Recruitment hospital [2]
0
0
Concord Hospital - Concord
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Recruitment hospital [3]
0
0
Dubbo Base Hospital - Dubbo
Query!
Recruitment hospital [4]
0
0
Ramsay Pharmacy - Kogarah
Query!
Recruitment hospital [5]
0
0
St George Private Hospital - Kogarah
Query!
Recruitment hospital [6]
0
0
Epic Pharmacy - Lismore
Query!
Recruitment hospital [7]
0
0
North Coast Radiology St Vincents - Lismore
Query!
Recruitment hospital [8]
0
0
Northern Rivers Pathology Service - Lismore
Query!
Recruitment hospital [9]
0
0
St Vincent's Pathology Lismore - Lismore
Query!
Recruitment hospital [10]
0
0
Macquarie Medical Imaging - Macquarie University
Query!
Recruitment hospital [11]
0
0
Macquarie University Hospital Pharmacy - Macquarie University
Query!
Recruitment hospital [12]
0
0
Macquarie University - Macquarie University
Query!
Recruitment hospital [13]
0
0
The Murwillumbah Hospital - Murwillubah
Query!
Recruitment hospital [14]
0
0
The Tweed Hospital Pharmacy Department - Tweed Heads
Query!
Recruitment hospital [15]
0
0
The Tweed Hospital - Tweed Heads
Query!
Recruitment hospital [16]
0
0
Icon Cancer Care Wesley - Auchenflower
Query!
Recruitment hospital [17]
0
0
River City Pharmacy - Auchenflower
Query!
Recruitment hospital [18]
0
0
Oncology Pharmacy - Birtinya
Query!
Recruitment hospital [19]
0
0
Sunshine Coast University Hospital - Birtinya
Query!
Recruitment hospital [20]
0
0
Icon Cancer Care Chermside - Chermside
Query!
Recruitment hospital [21]
0
0
The Townsville Hospital - Douglas
Query!
Recruitment hospital [22]
0
0
Slade Health - Geebung
Query!
Recruitment hospital [23]
0
0
Icon Cancer Care South Brisbane - South Brisbane
Query!
Recruitment hospital [24]
0
0
Icon Cancer Care - South Brisbane
Query!
Recruitment hospital [25]
0
0
Integrated Clinical Oncology Network (ICON) Corporate Office - South Brisbane
Query!
Recruitment hospital [26]
0
0
Icon Cancer Care Southport - Southport
Query!
Recruitment hospital [27]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [28]
0
0
SA Pharmacy, Level 3 Pharmacy - Bedford Park
Query!
Recruitment hospital [29]
0
0
Adelaide Cancer Centre - Kurralta Park
Query!
Recruitment hospital [30]
0
0
Ashford Cancer Centre Research - Kurralta park
Query!
Recruitment hospital [31]
0
0
Cancer Care SA Pty Ltd - Kurralta Park
Query!
Recruitment hospital [32]
0
0
Icon Cancer Care SA trading as Icon Pharmacy Adelaide - Kurralta Park
Query!
Recruitment hospital [33]
0
0
The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment hospital [34]
0
0
BHS Diagnostic Services - Ballarat
Query!
Recruitment hospital [35]
0
0
Lake Imaging - Ballarat
Query!
Recruitment hospital [36]
0
0
Ballarat Oncology & Haematology Services - Ballarat
Query!
Recruitment hospital [37]
0
0
Box Hill Hospital - Pharmacy Department, Bulding B, Loading Dock (access via Thames St) - Box Hill
Query!
Recruitment hospital [38]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [39]
0
0
Eastern Health Clinical School - Box Hill
Query!
Recruitment hospital [40]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [41]
0
0
Monash Medical Centre - East Bentleigh
Query!
Recruitment hospital [42]
0
0
Moorabbin Radiology - East Bentleigh
Query!
Recruitment hospital [43]
0
0
Ballarat Day Procedure Centre - Wendouree
Query!
Recruitment hospital [44]
0
0
Ballarat Oncology & Haematology Services - Wendouree
Query!
Recruitment hospital [45]
0
0
Nova Pharmacy - Wendouree
Query!
Recruitment hospital [46]
0
0
Fiona Stanley Hospital - Murdoch
Query!
Recruitment hospital [47]
0
0
St John of God Murdoch Hospital - Murdoch
Query!
Recruitment hospital [48]
0
0
Slade Health - Mount Waverley
Query!
Recruitment hospital [49]
0
0
Macquarie Heart - New South Wales
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [3]
0
0
2830 - Dubbo
Query!
Recruitment postcode(s) [4]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [5]
0
0
2480 - Lismore
Query!
Recruitment postcode(s) [6]
0
0
2109 - Macquarie University
Query!
Recruitment postcode(s) [7]
0
0
2484 - Murwillubah
Query!
Recruitment postcode(s) [8]
0
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [9]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [10]
0
0
4575 - Birtinya
Query!
Recruitment postcode(s) [11]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [12]
0
0
4814 - Douglas
Query!
Recruitment postcode(s) [13]
0
0
4034 - Geebung
Query!
Recruitment postcode(s) [14]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [15]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [16]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [17]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [18]
0
0
5037 - Kurralta park
Query!
Recruitment postcode(s) [19]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [20]
0
0
3350 - Ballarat
Query!
Recruitment postcode(s) [21]
0
0
3355 - Ballarat
Query!
Recruitment postcode(s) [22]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [23]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [24]
0
0
3165 - East Bentleigh
Query!
Recruitment postcode(s) [25]
0
0
3355 - Wendouree
Query!
Recruitment postcode(s) [26]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [27]
0
0
3149 - Mount Waverley
Query!
Recruitment postcode(s) [28]
0
0
2109 - New South Wales
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Colorado
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Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Massachusetts
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Minnesota
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Ohio
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Virginia
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Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Washington
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Buenos Aires
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Caba
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Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
La Rioja
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Brasschaat
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Brussels
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Bruxelles
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Gent
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Ghent
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Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Kortrijk
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Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Liège
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Wilrijk
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
BA
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
RIO Grande DO SUL
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
RJ
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
RS
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
SP
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
São Paulo
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Ontario
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Quebec
Query!
Country [27]
0
0
Czechia
Query!
State/province [27]
0
0
Ceska Republika
Query!
Country [28]
0
0
Czechia
Query!
State/province [28]
0
0
Brno
Query!
Country [29]
0
0
Czechia
Query!
State/province [29]
0
0
Horovice
Query!
Country [30]
0
0
Denmark
Query!
State/province [30]
0
0
Aalborg
Query!
Country [31]
0
0
Denmark
Query!
State/province [31]
0
0
Aarhus C
Query!
Country [32]
0
0
Denmark
Query!
State/province [32]
0
0
Aarhus N
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Country [33]
0
0
Denmark
Query!
State/province [33]
0
0
Copenhagen OE
Query!
Country [34]
0
0
Denmark
Query!
State/province [34]
0
0
Herlev
Query!
Country [35]
0
0
Denmark
Query!
State/province [35]
0
0
København Ø
Query!
Country [36]
0
0
Denmark
Query!
State/province [36]
0
0
Odense C
Query!
Country [37]
0
0
Denmark
Query!
State/province [37]
0
0
Odense
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Cedex 13
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Angers Cedex 02
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Angers
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Bayonne
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Country [42]
0
0
France
Query!
State/province [42]
0
0
BESANCON cedex
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Country [43]
0
0
France
Query!
State/province [43]
0
0
Besançon
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
CRÉTEIL Cedex
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Country [45]
0
0
France
Query!
State/province [45]
0
0
Hyères
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Le Mans
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Lille cedex
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Country [48]
0
0
France
Query!
State/province [48]
0
0
Lille
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Country [49]
0
0
France
Query!
State/province [49]
0
0
Lyon cedex 8
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Country [50]
0
0
France
Query!
State/province [50]
0
0
LYON cedex 8
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Marseille cedex 5
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Marseille Cedex 9
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Marseille
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Nimes Cedex 9
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Nimes
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Country [56]
0
0
France
Query!
State/province [56]
0
0
PARIS cedex 13
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Paris
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Rennes Cedex
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Country [59]
0
0
France
Query!
State/province [59]
0
0
Rouen Cedex 1
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Rouen
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Saint Herblain Cedex
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Strasbourg
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Country [63]
0
0
France
Query!
State/province [63]
0
0
Suresnes
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Country [64]
0
0
France
Query!
State/province [64]
0
0
Villejuif cedex
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Country [65]
0
0
France
Query!
State/province [65]
0
0
Villejuif
Query!
Country [66]
0
0
Greece
Query!
State/province [66]
0
0
Athens
Query!
Country [67]
0
0
Greece
Query!
State/province [67]
0
0
PC
Query!
Country [68]
0
0
Greece
Query!
State/province [68]
0
0
Patra
Query!
Country [69]
0
0
Greece
Query!
State/province [69]
0
0
Thessaloniki
Query!
Country [70]
0
0
Hong Kong
Query!
State/province [70]
0
0
Hong Kong
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Kaposvár
Query!
Country [72]
0
0
India
Query!
State/province [72]
0
0
Delhi
Query!
Country [73]
0
0
India
Query!
State/province [73]
0
0
Gujarat
Query!
Country [74]
0
0
India
Query!
State/province [74]
0
0
Maharashtra
Query!
Country [75]
0
0
India
Query!
State/province [75]
0
0
Telangana
Query!
Country [76]
0
0
India
Query!
State/province [76]
0
0
WEST Bengal
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Jerusalem
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Ramat - GAN
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Beer Yaakov
Query!
Country [80]
0
0
Israel
Query!
State/province [80]
0
0
Haifa
Query!
Country [81]
0
0
Israel
Query!
State/province [81]
0
0
Ramat - Gan
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
(torino)
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Ancona
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Forli-cesena
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Genoa
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Liguria
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Milan
Query!
Country [88]
0
0
Italy
Query!
State/province [88]
0
0
Ravenna
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
Torino
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Arezzo
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Aviano (PN)
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Bologna
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Naples
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Napoli
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Pisa
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Rome
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Terni
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Aichi
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Aomori
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Ehime
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Gunma
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Hokkaido
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Hyogo
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Ibaraki
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Iwate
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Kanagawa
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Osaka
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Saitama
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Shizuoka
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Tokyo
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Yamaguchi
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Chiba
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Fukuoka
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Hiroshima
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Kagoshima
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Kumamoto
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Niigata
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Tokushima
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Yamagata
Query!
Country [120]
0
0
Korea, Republic of
Query!
State/province [120]
0
0
Gyeonggi-do
Query!
Country [121]
0
0
Korea, Republic of
Query!
State/province [121]
0
0
Gyeonggido
Query!
Country [122]
0
0
Korea, Republic of
Query!
State/province [122]
0
0
Daejeon
Query!
Country [123]
0
0
Korea, Republic of
Query!
State/province [123]
0
0
Seoul
Query!
Country [124]
0
0
Mexico
Query!
State/province [124]
0
0
Ciudad DE Mexico
Query!
Country [125]
0
0
Mexico
Query!
State/province [125]
0
0
Estado DE Mexico
Query!
Country [126]
0
0
Mexico
Query!
State/province [126]
0
0
Guanajuato
Query!
Country [127]
0
0
Netherlands
Query!
State/province [127]
0
0
Arnhem
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
Haarlem
Query!
Country [129]
0
0
Netherlands
Query!
State/province [129]
0
0
Hoofddorp
Query!
Country [130]
0
0
Netherlands
Query!
State/province [130]
0
0
Maastricht
Query!
Country [131]
0
0
Netherlands
Query!
State/province [131]
0
0
Nijmegen
Query!
Country [132]
0
0
New Zealand
Query!
State/province [132]
0
0
Auckland
Query!
Country [133]
0
0
New Zealand
Query!
State/province [133]
0
0
Auckalnd
Query!
Country [134]
0
0
New Zealand
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State/province [134]
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Christchurch
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Country [135]
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New Zealand
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Hamilton
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Country [136]
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Norway
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State/province [136]
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Lorenskog
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Country [137]
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Norway
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State/province [137]
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Nordbyhagen
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Norway
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Stavanger
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Country [139]
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Poland
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Masovian
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Country [140]
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Poland
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State/province [140]
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Lublin
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Country [141]
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Poland
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State/province [141]
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Torun
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Country [142]
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Portugal
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State/province [142]
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Coimbra
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Portugal
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State/province [143]
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Lisboa
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Country [144]
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Portugal
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Porto
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Country [145]
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Portugal
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State/province [145]
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Senhora da Hora
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Country [146]
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Portugal
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Vila Real
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Russian Federation
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Bashkortostan Republic
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Country [148]
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Russian Federation
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State/province [148]
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Kaluzhskaya Region
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Country [149]
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Russian Federation
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State/province [149]
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Saint Petersburg
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Country [150]
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Russian Federation
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State/province [150]
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Moscow
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Country [151]
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Russian Federation
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State/province [151]
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Omsk
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Country [152]
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Russian Federation
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State/province [152]
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St. Petersburg
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Country [153]
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Russian Federation
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State/province [153]
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Yaroslavl
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Country [154]
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Serbia
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State/province [154]
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Belgrade
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Country [155]
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Serbia
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Nis
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Country [156]
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Serbia
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State/province [156]
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Sremska Kamenica
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Country [157]
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Spain
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State/province [157]
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A Coruña
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Country [158]
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Spain
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Alicante
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Country [159]
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Spain
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State/province [159]
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Asturias
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Country [160]
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Spain
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State/province [160]
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Barcelona
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Country [161]
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Spain
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State/province [161]
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Comunidad Valenciana
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Country [162]
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Spain
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State/province [162]
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Galicia
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Country [163]
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Spain
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State/province [163]
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Madrid
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Country [164]
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Spain
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Navarra
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Country [165]
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Spain
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Badajoz
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Country [166]
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Spain
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State/province [166]
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Cordoba
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Country [167]
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Spain
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State/province [167]
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Gerona
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Country [168]
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Spain
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State/province [168]
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Lugo
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Country [169]
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Spain
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State/province [169]
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Sevilla
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Country [170]
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Spain
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Valencia
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Country [171]
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Sweden
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State/province [171]
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Stockholm
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Country [172]
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Taiwan
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Taichung
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Taiwan
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Tainan
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Country [174]
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Taiwan
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State/province [174]
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Taipei
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Country [175]
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Taiwan
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State/province [175]
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Taoyuan
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Country [176]
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United Kingdom
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State/province [176]
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Bath
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Country [177]
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United Kingdom
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State/province [177]
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London
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Country [178]
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Ethics approval
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Summary
Brief summary
The main purpose of this study is to compare maintenance treatment with avelumab plus best
supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in
patients with locally advanced or metastatic urothelial cancer that did not worsen during or
following completion of first-line chemotherapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02603432
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02603432
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