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

简要总结

主要结局

次要结局

• Percentage of Participants With Objective Response as Assessed by Investigator(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))
• Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)(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))
• Percentage of Participants With Disease Control (DC) as Assessed by Blinded Independent Central Review (BICR)(From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months))
• Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03(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))
• Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)(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))
• Time to Tumor Response (TTR) as Assessed by Blinded Independent Central Review (BICR)(From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months))
• Percentage of Participants With Disease Control (DC) as Assessed by Investigator(From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months))
• Maximum Plasma Concentration (Cmax) of Avelumab(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))
• Number of ADA Ever Positive Participants For Each Serum of ADA Titers for Avelumab(From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months))
• Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)(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))
• Progression-Free Survival (PFS) as Assessed by Investigator(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))
• Time to Tumor Response (TTR) as Assessed by Investigator(From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months))
• Duration of Response (DOR) as Assessed by Investigator(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))
• 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(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))
• Predose Plasma Concentration (Ctrough) of Avelumab(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))
• 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(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))
• Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never Positive and Ever Positive Status(From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months))
• Number of Participants With Programmed Death Receptor-1 Ligand 1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)(Up to 41 months at the time of the analysis)
• Number of Participants With Cluster of Differentiation 8 (CD8) T Lymphocytes (Cytotoxic T Lymphocytes)(Up to approximately 60 months)
• 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(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))
• 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(From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months))
• Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status(From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months))
• Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6(Baseline, Day 1 of Cycle 6 (1 cycle=28 days))
• 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(Baseline, Day 1 of Cycle 6 (1 cycle=28 days))
• Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6(Baseline, Day 1 of Cycle 6 (1 cycle=28 days))