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A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603432
Recruitment Status : Active, not recruiting
First Posted : November 11, 2015
Results First Posted : December 17, 2020
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Urothelial Cancer Biological: Avelumab Other: Best Supportive Care Biological: Following the planned interim analysis for this study: Avelumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 25, 2016
Actual Primary Completion Date : October 21, 2019
Estimated Study Completion Date : June 3, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arm Intervention/treatment
Experimental: Arm A
Avelumab plus Best Supportive Care (BSC)
Biological: Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles

Other: 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.

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.

Other: 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.

Biological: Following the planned interim analysis for this study: Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (maximum duration of up to 41 months at the time of final analysis) ]
    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.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (maximum duration of up to 41 months at the time of the analysis) ]
    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 (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 new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.

  2. Progression-Free Survival (PFS) as Assessed by Investigator [ Time Frame: From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  3. Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  4. Percentage of Participants With Objective Response as Assessed by Investigator [ Time Frame: From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  5. Time to Tumor Response (TTR) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: From the date of randomization to the first documentation of objective response (CR or PR) (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  6. Time to Tumor Response (TTR) as Assessed by Investigator [ Time Frame: From the date of randomization to the first documentation of objective response (CR or PR) (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  7. Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: 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 (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  8. Duration of Response (DOR) as Assessed by Investigator [ Time Frame: 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 (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  9. Percentage of Participants With Disease Control (DC) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: From randomization to PD, death or start of new anti-cancer therapy (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  10. Percentage of Participants With Disease Control (DC) as Assessed by Investigator [ Time Frame: From randomization to PD, death or start of new anti-cancer therapy (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  11. Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 [ Time Frame: For "Avelumab + Best Supportive Care (BSC)'' group: Day 1 up to 90 days after last dose of study drug; for "Best Supportive Care'' group: Day 1 up to 90 days after EOT visit, for a maximum duration of up to 41 months at the time of the analysis ]
    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.

  12. 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 [ Time Frame: For "Avelumab + Best Supportive Care (BSC)'' group: Day 1 up to 90 days after last dose of study drug; for "Best Supportive Care'' group: Day 1 up to 90 days after EOT visit, for a maximum duration of up to 41 months at the time of the analysis ]
    Hematology (Anemia G3: hemoglobin<8.0 grams per deciliter [g/dL],<4.9 mmol/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]).

  13. 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 [ Time Frame: Baseline (D1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum duration of up to 41 months at the time of the analysis) ]
    Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP).

  14. 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 [ Time Frame: Baseline (D1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum duration of up to 41 months at the time of the analysis) ]
    Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.

  15. Maximum Plasma Concentration (Cmax) of Avelumab [ Time Frame: 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 ]
    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.

  16. Predose Plasma Concentration (Ctrough) of Avelumab [ Time Frame: 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 ]
    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.

  17. Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status [ Time Frame: From randomization up to the 30-Day Follow-up visit (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  18. Number of ADA Ever Positive Participants For Each Serum of ADA Titers for Avelumab [ Time Frame: From randomization up to the 30-Day Follow-up visit (maximum duration of up to 41 months at the time of the analysis) ]
    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 43740) are reported.

  19. Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never Positive and Ever Positive Status [ Time Frame: Up to approximately 60 months ]
  20. Number of Participants With Programmed Death Receptor-1 Ligand 1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC) [ Time Frame: Up to 41 months at the time of the analysis ]
    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.

  21. Number of Participants With Cluster of Differentiation 8 (CD8) T Lymphocytes (Cytotoxic T Lymphocytes) [ Time Frame: Up to approximately 60 months ]
  22. 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 [ Time Frame: Baseline, Day 1 of Cycle 6 ]
    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.

  23. 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 [ Time Frame: From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months at the time of the analysis) ]
    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.

  24. Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6 [ Time Frame: Baseline, Day 1 of Cycle 6 ]
    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.

  25. Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6 [ Time Frame: Baseline, Day 1 of Cycle 6 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 )

Exclusion Criteria:

  • Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
  • Prior immunotherapy with IL-2, IFN-α, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603432


Locations
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United States, Colorado
Anschutz Cancer Center Pavilion Pharmacy
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
University of Colorado Denver, CTO (CTRC)
Aurora, Colorado, United States, 80045
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, United States, 80045
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, United States, 80045
United States, Connecticut
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06510
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Cleveland Clinic Taussing Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Virginia
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Argentina
Centro de Investigacion Pergamino S.A.
Pergamino, Buenos Aires, Argentina, B2700CPM
Fundación CENIT para la Investigación en Neurociencias
Caba, Argentina, C1125ABD
GP Diagnostico SRL
La Rioja, Argentina, 5300
Hospital Regional Dr. Enrique Vera Barros
La Rioja, Argentina, 5300
Instituto del Diagnostico
La Rioja, Argentina, 5300
Centro Oncologico Riojano Integral (Cori)
La Rioja, Argentina, F5300COE
Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Concord Hospital
Concord, New South Wales, Australia, 2139
Dubbo Base Hospital
Dubbo, New South Wales, Australia, 2830
Ramsay Pharmacy
Kogarah, New South Wales, Australia, 2217
St George Private Hospital
Kogarah, New South Wales, Australia, 2217
Epic Pharmacy
Lismore, New South Wales, Australia, 2480
North Coast Radiology St Vincents
Lismore, New South Wales, Australia, 2480
Northern Rivers Pathology Service
Lismore, New South Wales, Australia, 2480
St Vincent's Pathology Lismore
Lismore, New South Wales, Australia, 2480
Macquarie University Hospital Pharmacy
Macquarie University, New South Wales, Australia, 2109
Macquarie University
Macquarie University, New South Wales, Australia, 2109
Slade Pharmacy
Mount Kuring-Gai, New South Wales, Australia, 2080
The Murwillumbah Hospital
Murwillubah, New South Wales, Australia, 2484
Macquarie Medical Imaging
North Ryde, New South Wales, Australia, 2109
The Tweed Hospital Pharmacy Department
Tweed Heads, New South Wales, Australia, 2485
The Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Australia, Queensland
Icon Cancer Care Wesley
Auchenflower, Queensland, Australia, 4066
River City Pharmacy
Auchenflower, Queensland, Australia, 4066
Oncology Pharmacy
Birtinya, Queensland, Australia, 4575
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Icon Cancer Care Chermside
Chermside, Queensland, Australia, 4032
The Townsville Hospital
Douglas, Queensland, Australia, 4814
Slade Health
Geebung, Queensland, Australia, 4034
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care Southport
Southport, Queensland, Australia, 4215
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
SA Pharmacy, Level 3 Pharmacy
Bedford Park, South Australia, Australia, 5042
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia, 5037
Ashford Cancer Centre Research
Kurralta park, South Australia, Australia, 5037
Cancer Care SA Pty Ltd
Kurralta Park, South Australia, Australia, 5037
Icon Cancer Care SA trading as Icon Pharmacy Adelaide
Kurralta Park, South Australia, Australia, 5037
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
BHS Diagnostic Services
Ballarat, Victoria, Australia, 3350
Lake Imaging
Ballarat, Victoria, Australia, 3350
Ballarat Oncology & Haematology Services
Ballarat, Victoria, Australia, 3355
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Eastern Health Clinical School
Box Hill, Victoria, Australia, 3128
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Monash Cancer Centre
East Bentleigh, Victoria, Australia, 3165
Moorabbin Radiology
East Bentleigh, Victoria, Australia, 3165
Ballarat Day Procedure Centre
Wendouree, Victoria, Australia, 3355
Ballarat Oncology & Haematology Services
Wendouree, Victoria, Australia, 3355
Nova Pharmacy
Wendouree, Victoria, Australia, 3355
Australia, Western Australia
SKG Radiology
Murdoch, Western Australia, Australia, 6050
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia, 6150
Australia
Slade Health
Mount Waverley, Australia, 3149
Macquarie Heart
New South Wales, Australia, 2109
Belgium
AZ Klina - Apotheek
Brasschaat, Belgium, 2930
AZ Klina
Brasschaat, Belgium, 2930
Hôpital Erasme
Brussels, Belgium, 1070
Hôpital Erasme
Bruxelles, Belgium, 1070
UZ Gent
Gent, Belgium, 9000
UZ Gent
Ghent, Belgium, 9000
AZ Groeninge
Kortrijk, Belgium, 8500
CHU de Liège
Liège, Belgium, 4000
GZA Sint-Augustinus
Wilrijk, Belgium, 2610
Brazil
Hospital da Bahia
Salvador, BA, Brazil, 41820-011
CENOB Centro de Oncologia da Bahia S/S Ltda. / Oncovida
Salvador, BA, Brazil, 41820-021
Hospital Mãe de Deus/Aesc
Porto Alegre, RIO Grande DO SUL, Brazil, 90110-270
Instituto Nacional de Câncer - INCA
Rio de Janeiro, RJ, Brazil, 20230-130
Associação Hospital de Caridade Ijuí / Hospital de Caridade de Ijuí
Ijuí, RS, Brazil, 98700-000
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus
Porto Alegre, RS, Brazil, 90110-000
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Ambulatório Quimioterapia
Porto Alegre, RS, Brazil, 90110-270
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Centro de Abastecimento Farmaceu
Porto Alegre, RS, Brazil, 90110-270
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Farmácia Oncológica
Porto Alegre, RS, Brazil, 90110-270
Associação Educadora São Carlos - AESC / Hospital Mãe de Deus
Porto Alegre, RS, Brazil, 90110-270
Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS
Porto Alegre, RS, Brazil, 90610-000
Fundação FPio XII Barretos
Barretos, SP, Brazil, 14784-400
Fundação Pio XII Barretos
Barretos, SP, Brazil, 14784-400
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Fundacao Faculdade de Medicina / Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Hospital Alemao Oswaldo Cruz
Sao Paulo, SP, Brazil, 01323-903
Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP
Sao Paulo, SP, Brazil, 05403-900
Centro Integrado de Pesquisa Clinica - CIP
São José do Rio Preto, SP, Brazil, 15090-000
Sociedade Beneficente de Senhoras Hospital Sírio Libanês
São Paulo, SP, Brazil, 01308-050
Hospital Israelita Albert Einstein - SP
São Paulo, SP, Brazil, 05652-900
Sociedade Beneficente de Senhoras Hospital Sírio Libanês/ Instituo Sirio Libanes de Ensino e Pesqu
São Paulo, Brazil, 01308-060
Canada, Ontario
William Osler Health System
Brampton, Ontario, Canada, L6R 3J7
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM - Centre Hospitalier de l'Universite de Montreal
Montréal, Quebec, Canada, H2X 3E4
Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, Ceska Republika, Czechia, 656 91
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Fakultni nemocnice u sv.Anny v Brne
Brno, Czechia, 656 91
Nemocnice Horovice, NH Hospital a.s.
Horovice, Czechia, 268 31
Nemocnice Horovice
Horovice, Czechia, 268 31
Denmark
Aalborg Universitetshospital Syd
Aalborg, Denmark, 9000
Aalborg Universitetshospital
Aalborg, Denmark, 9000
Sygehusapoteket Aalborg
Aalborg, Denmark, 9000
Aarhus Universitetshospital
Aarhus C, Denmark, 8000
Aarhus Universitetshospital
Aarhus N, Denmark, 8200
CT-Klinikken A/S
Aarhus N, Denmark, 8200
Rigshospitalet, Onkologisk Klinik, afsnit 5073
Copenhagen OE, Denmark, 2100
Herlev Hospital
Herlev, Denmark, 2730
Herlev og Gentofte Hospital
Herlev, Denmark, 2730
Klinik for Klinisk Fysiologi,Nuklearmedicin og PET
København Ø, Denmark, 2100
Rigshospitalet
København Ø, Denmark, 2100
Odense Universitetshospital
Odense C, Denmark, 5000
Odense Universitetshospital
Odense, Denmark, 5000
France
Groupe hospitalier Pitie Saleptriere
Paris, Cedex 13, France, 75651
Institut de cancérologie de l'Ouest - Site Paul Papin
Angers Cedex 02, France, 49055
Institut de cancérologie de l'Ouest - Site Paul Papin
Angers, France, 49100
Centre d'Oncologie et de Radiothérapie du Pays-Basque
Bayonne, France, 64100
Clinique CAPIO Belharra
Bayonne, France, 64100
Hôpital Jean Minjoz
BESANCON cedex, France, 25030
CHU Besançon
Besançon, France, 25030
Hôpital Henri Mondor
CRÉTEIL Cedex, France, 94010
Hôpital Privé Toulon-Hyères - Clinique Sainte Marguerite
Hyères, France, 83400
Clinique Victor Hugo
Le Mans, France, 72015
Centre Oscar Lambret
Lille cedex, France, 59020
Centre Oscar Lambret
Lille, France, 59000
Centre Leon Berard
Lyon cedex 8, France, 69373
Centre Léon Berard
LYON cedex 8, France, 69373
Hopital La Conception
Marseille cedex 5, France, 13285
Institut Paoli Calmettes
Marseille Cedex 9, France, 13273
Institut Paoli Calmettes
Marseille, France, 13009
Hopital de La Timone
Marseille, France, 13385 cedex 05
Hopital de La Timone
Marseille, France, 13385
CHU Nimes - Institut de Cancerologie du Gard
Nimes Cedex 9, France, 30029
CHU Nimes
Nimes Cedex 9, France, 30029
CHU Nimes - Hopital Caremeau
Nimes, France, 30000
Groupe Hospitalier Pitié Salpêtrière
PARIS cedex 13, France, 75651
Groupe Hospitalier Pitié Salpêtrière
Paris, France, 75013
Centre Eugene Marquis
Rennes Cedex, France, 35042
Centre Henri Becquerel
Rouen Cedex 1, France, 76038
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France, 76031
CHU de Rouen
Rouen, France, 76031
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint Herblain Cedex, France, 44805
Centre de Radiothérapie - Clinique Sainte Anne
Strasbourg, France, 67000
Clinique Sainte Anne
Strasbourg, France, 67000
Hopital FOCH
Suresnes, France, 92150
Hopital Foch
Suresnes, France, 92151
Institut Gustave Roussy
Villejuif cedex, France, 94805
Institut Gustave Roussy
Villejuif, France, 94805
Greece
Medical Center of Athens
Marousi, Athens, Greece, 15125
Metropolitan General Hospital
Athens, PC, Greece, 11562
Sotiria General Chest Disease Hospital
Athens, Greece, 11527
Alexandra General Hospital, Oncology Department
Athens, Greece, 11528
University General Hospital of Patras, Division of Oncology
Patra, Greece, 26504
EUROMEDICA General Clinic of Thessaloniki
Thessaloniki, Greece, 546 45
Hong Kong
Department of Clinical Oncology
Hong Kong, Hong Kong
Hungary
Kaposvári Egyetem Egészségügyi Centrum
Kaposvár, Hungary, 7400
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Hungary, 7400
India
Dr Ram Manohar Lohia (RML) Hospital & PGI MER
New Delhi, Delhi, India, 110001
CIMS Cancer, Care Institute of Medical Sciences, CIMS Hospital
Ahmedabad, Gujarat, India, 380060
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India, 411004
Apollo Hospitals
Hyderabad, Telangana, India, 500096
Medica Superspecialty hospital
Kolkata, WEST Bengal, India, 700099
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, India, 110085
Israel
Hadassah University Hospital
Kiryat Hadassah, Jerusalem, Israel, 91120
The Chaim Sheba Medical Center
Tel-Hashomer, Ramat - GAN, Israel, 5265601
Assaf Harofe MC
Beer Yaakov, Israel, 70300
Rambam Health Care Campus
Haifa, Israel, 31096
The Chaim Sheba Medical Center
Ramat - Gan, Israel, 5265601
Italy
Farmacia Ospedaliera
Candiolo, (torino), Italy, 10060
AOU Ospedali Riuniti di Ancona
Torrette, Ancona, Italy, 60126
U.O. Anatomia Patologica
Forli, Forli-cesena, Italy, 47121
U.O. Radiologia
Forli, Forli-cesena, Italy, 47121
U.O.S. Medicina Nucleare
Forli, Forli-cesena, Italy, 47121
Farmacia Oncologica
Meldola, Forli-cesena, Italy, 47014
Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori
Meldola, Forli-cesena, Italy, 47014
Farmacia Studi Clinici
Rozzano, Milan, Italy, 20089
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
AUSL della Romagna - RAVENNA, Presidio Ospedaliero di Faenza
Faenza, Ravenna, Italy, 48018
Presidio Ospedaliero di Lugo
Lugo, Ravenna, Italy, 48022
Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo
Candiolo, Torino, Italy, 10060
Farmacia Ospedaliera
Arezzo, Italy, 52100
Presidio Ospedaliero San Donato
Arezzo, Italy, 52100
Centro di Riferimento Oncologico - IRCCS
Aviano (PN), Italy, 33081
S.O.C. di Farmacia
Aviano (PN), Italy, 33081
Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi
Bologna, Italy, 40138
U.O. Farmacia Clinica - IDS
Bologna, Italy, 40138
IRCCS AOU San Martino - IST
Genova, Italy, 16132
U.O.C. Farmacia
Genova, Italy, 16132
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, Italy, 20133
SC Farmacia
Milan, Italy, 20133
Instituto Europeo di Oncologia
Milan, Italy, 20141
Servizio di Farmacia
Milan, Italy, 20141
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Naples, Italy, 80131
UOSC Farmacia
Naples, Italy, 80131
Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale
Napoli, Italy, 80131
S.C. Farmacia Ospedaliera
Napoli, Italy, 80131
A.O.U. Pisana Ospedale S. Chiara
Pisa, Italy, 56126
U.O. Farmacia Ospedaliera
Pisa, Italy, 56126
Presidio Ospedaliero di Ravenna
Ravenna, Italy, 48121
Servizio Farmacia Ospedaliera - Farmacia Oncologica
Ravenna, Italy, 48121
Azienda Ospedaliera San Camillo Forlanini_Oncologia Medica
Rome, Italy, 00152
U.O.C. Farmacia
Rome, Italy, 00152
Azienda Ospedaliera S. Maria di Terni
Terni, Italy, 05100
S.C. Farmacia Interna
Terni, Italy, 05100
Japan
Nagoya University Hospital
Nagoya, Aichi, Japan, 466-8560
Hirosaki University School of Medicine & Hospital
Hirosaki, Aomori, Japan, 036-8563
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Gunma Prefectural Cancer Center
Ota, Gunma, Japan, 373-8550
National Hospital Organization hokkaido Cancer Center
Sapporo,, Hokkaido, Japan, 0030804
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital
Kobe-city, Hyogo, Japan, 650-0047
Tsukuba Medical Center Hospital
Tsukuba, Ibaraki, Japan, 305-8558
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan, 028-3695
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan, 252-0392
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Kindai University Hospital
Osakasayama, Osaka, Japan, 589-8511
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan, 350-1298
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, Japan, 343-8555
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
Japanese Foundation For Cancer Research Cancer Institute Hospital
Koto-ku, Tokyo, Japan, 135-8550
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan, 160-8582
Yamaguchi University Hospital
Ube, Yamaguchi, Japan, 755-8505
Chiba Cancer Center
Chiba, Japan, 260-8717
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan, 730-8518
Kagoshima University Hospital
Kagoshima, Japan, 890-8520
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan, 860-0008
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Osaka City University Hospital
Osaka, Japan, 545-8586
Tokushima University Hospital
Tokushima, Japan, 770-8503
Yamagata University Hospital
Yamagata, Japan, 990-9585
Korea, Republic of
National Cancer Center - Clinical Trial Pharmacy
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
National Cancer Center Urology center for Prostate Cancer
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital, Clinical Pharmacy
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Chungnam National University Hospital, Clinical Pharmacy
Daejeon, Korea, Republic of, 35015
Chungnam National University Hospital
Daejeon, Korea, Republic of, 35015
Severance Hospital Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center - Clinical Trial Pharmacy
Seoul, Korea, Republic of, 05505
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center Clinical Trial Pharmacy
Seoul, Korea, Republic of, 06351
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Mexico
Instituto Nacional de Cancerologia
Mexico, Ciudad DE Mexico, Mexico, 14080
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlan Izcalli, Estado DE Mexico, Mexico, 54769
Centro de Investigación Clínica de Leon S.C.
Leon, Guanajuato, Mexico, 37520
Hospital Médica Campestre (Administradora Hospitalaria S.A de C.V.)
León, Guanajuato, Mexico, 37180
Netherlands
Rijnstate Arnhem
Arnhem, Netherlands, 6815 AD
Ziekenhuis Rijnstate
Arnhem, Netherlands, 6815 AD
St Apotheek der Haarlemse Ziekenhuizen
Haarlem, Netherlands, 2035 RC
Spaarne Gasthuis
Hoofddorp, Netherlands, 2134 TM
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Radboudumc
Nijmegen, Netherlands, 6525 GA
New Zealand
Auckland City Hospital Pharmacy
Grafton, Auckland, New Zealand, 1023
Auckland City Hospital
Grafton, Auckland, New Zealand, 1142
Christchurch Hospital
Christchurch, New Zealand, 8140
Waikato Hospital
Hamilton, New Zealand, 3240
Norway
Akershus University Hospital
Lorenskog, Norway, 1478
Sykehusapoteket HF 23 Lørenskog
Lorenskog, Norway, 1478
Sykehusapoteket HF 23 Lørenskog
Nordbyhagen, Norway, 1474
Bildediagnostisk avdeling
Nordbyhagen, Norway, 1478
Stavanger University Hospital
Stavanger, Norway, 4011
Poland
Centralny Szpital Kliniczny MSWiA
Warszawa, Masovian, Poland, 02-507
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli
Lublin, Poland, 20-090
Lecznice CITOMED Sp. z o.o.
Torun, Poland, 87-100
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny
Torun, Poland, 87-100
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Poland, 87-100
Wojewodzki Szpital Zespolony im. L. Rydygiera, Szpital Specjalistyczny dla Dzieci I Doroslych
Torun, Poland, 87-100
Portugal
Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE
Coimbra, Portugal, 3000-075
Hospital da Luz Coimbra
Coimbra, Portugal, 3020-479
IMACENTRO - Clínica de Imagiologia Médica do Centro, SA
Coimbra, Portugal, 3020-479
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos
Lisboa, Portugal, 1169-050
Hospital CUF Descobertas, SA
Lisboa, Portugal, 1998-018
Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.
Porto, Portugal, 4050-075
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Centro Hospitalar de São João, EPE
Porto, Portugal, 4200-319
Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
Vila Real, Portugal, 5000-508
Russian Federation
State Budgetary Healthcare Insti. Republican Clinical Oncology Dispensary of the MoH of Bashk. Rep.
Ufa, Bashkortostan Republic, Russian Federation, 450054
Federal State Budgetary Institution "National medical research radiology center" MoH RF
Obninsk, Kaluzhskaya Region, Russian Federation, 249036
Private Medical Institution "Evromedservice"
Pushkin, Saint Petersburg, Russian Federation, 196603
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, Russian Federation, 105229
Moscow Research Oncology Institute named after P. A. Gertsen
Moscow, Russian Federation, 125284
BHI of Omsk region "Clinical oncological dispensary"
Omsk, Russian Federation, 644013
FGBIH "Clinical Hospital #122 n.a. L.G. Sokolov of Federal Medico-biological agency"
St. Petersburg, Russian Federation, 194291
Non-State Healthcare Institution "Railway Clinical Hospital JSC RZhD"
St. Petersburg, Russian Federation, 195271
FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov" MoH RF
St. Petersburg, Russian Federation, 197022
FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov"
St. Petersburg, Russian Federation, 197022
FSBEI HE"First St. Petersburg State Medical University n.a. acad. I.P.Pavlov" MoH RF
St. Petersburg, Russian Federation, 197022
"Ramsay Diagnostics Rus", LLC
St. Petersburg, Russian Federation, 197046
FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
St. Petersburg, Russian Federation, 197758
Hospital Orkli, LLC
St. Petersburg, Russian Federation, 199178
Mart, Llc
St. Petersburg, Russian Federation, 199178
SHI YR "Regional Clinical Oncology Hospital"
Yaroslavl, Russian Federation, 150054
Serbia
Institute for Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
Clinical Centre Nis, Clinic of Oncology
Nis, Serbia, 18000
Oncology Institute of Vojvodina
Sremska Kamenica, Serbia, 21204
Spain
C.H. Univ. Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15706
Hospital Comarcal General de Elda de Virgen de la Salud
Elda, Alicante, Spain, 03600
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33011
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Institut Catalá d'Oncología - Hospital Duran i Reynals
l´Hospitalet de LLobregat, Barcelona, Spain, 08908
Institut Catalá d'Oncología
L´Hospitalet de Llobregat, Barcelona, Spain, 08908
Althaia. Xarxa Assistencial Universitaria de Manresa
Manresa, Barcelona, Spain, 08243
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Hospital General Universitario de Elche
Elche, Comunidad Valenciana, Spain, 03203
Hospital Clinico Universitario de Valencia
Valencia, Comunidad Valenciana, Spain, 46010
C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro
Vigo, Galicia, Spain, 36312
C.H. Universitario de Vigo- Hospital Meixoeiro
Vigo, Galicia, Spain, 36313
Hospital Universitario Infanta Sofia
San Sebastian de los Reyes, Madrid, Spain, 28702
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain, 28702
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Vithas Internacional Medimar
Alicante, Spain, 03016
Hospital Infanta Cristina
Badajoz, Spain, 06080
Hospital del Mar
Barcelona, Spain, 08003
Hospital Quiron of Barcelona
Barcelona, Spain, 08023
Hospital Quirón de Barcelona
Barcelona, Spain, 08023
Hospital de La Santa Creu i Sant pau_Oncology department
Barcelona, Spain, 08025
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain, 08025
CETIR Grup Medic
Barcelona, Spain, 08029
Cetir, Centre Mèdic, S.L
Barcelona, Spain, 08029
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Hospital Universitario Reina Sofía
Cordoba, Spain, 14004
Institut Catala d'Oncologia
Gerona, Spain, 17007
Institut Diagnostic de la lmatge
Gerona, Spain, 17007
Hospital Universitario Lucus Augusti
Lugo, Spain, 27003
Fundacion Maria Rafols para la investigacion del Diagnostico de la imagen
Madrid, Spain, 28006
Gabinete Radiologico Doctor Pita
Madrid, Spain, 28006
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Ruber Internacional
Madrid, Spain, 28034
Hospital Ruber International
Madrid, Spain, 28034
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, Spain, 28050
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Hospital Clinico Universitario de Valencia
Valencia, Spain, 4610
Sweden
APL
Stockholm, Sweden, 171 64
Karolinska University Hospital
Stockholm, Sweden, 171 76
Taiwan
Clinical Trial Pharmacy, China Medical University Hospital
Taichung, Taiwan, 40447
China Medical University Hospital
Taichung, Taiwan, 404
Department of Pharmacy, National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Investigational Drug services, National Taiwan University Hospital
Taipei, Taiwan, 100
National Taiwan University Hospital
Taipei, Taiwan, 100
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, 112
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 333
Chemotherapy pharmacy, Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 333
United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom, BA1 3NG
St Bartholomew 's Hospital, Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
St. Bartholomew's Hospital, Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Guy's & St. Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
London, United Kingdom, SE1 9RT
Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] February 13, 2020
Statistical Analysis Plan  [PDF] April 2, 2019

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02603432    
Other Study ID Numbers: B9991001
2015-003262-86 ( EudraCT Number )
JAVELIN BLADDER 100 ( Other Identifier: Alias Study Number )
First Posted: November 11, 2015    Key Record Dates
Results First Posted: December 17, 2020
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Bladder cancer
Urologic neoplasms
urothelial carcinoma
PD-L1
programmed cell death protein
maintenance treatment
Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs