A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

简要总结

主要结局

次要结局

• Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression(From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months))
• DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression(From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 89 months))
• TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression(From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months))
• Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression(From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months))
• Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03(From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months))
• Number of Participants Who Discontinued Treatment Due to Toxicity(From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months))
• Trough Plasma Concentration (Ctrough) of Avelumab(Pre dose (0 hour) on Day 1, 15 and 29 of Cycle 1, Day 1 and 29 of Cycles 2, 3, 4 and Day 1 of Cycle 6)
• Ctrough of Axitinib(Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks))
• Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups(From date of randomization until PD (maximum up to approximately 26 months))
• TTR in Biomarker-Positive Subgroup(From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months))
• Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib(From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months))
• PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression(From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months))
• OS in Participants Irrespective of PD-L1 Expression(From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months))
• Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression(From date of randomization until PD (maximum up to approximately 89 months))
• Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score(Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months))
• Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression(From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 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 (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days))
• Maximum Plasma Concentration (Cmax) of Axitinib(2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1)
• Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue(At screening)
• Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression(From date of randomization until PD (maximum up to approximately 26 months))
• Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression(From date of randomization until PD (maximum up to approximately 26 months))
• Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit(Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days))
• Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression(From date of randomization until PD (maximum up to approximately 89 months))
• PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression(From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months))
• Number of Participants According to Grade Shift in Hematology Parameters(From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months))
• Number of Participants According to Grade Shift in Chemistry Parameters(From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months))
• Time to Treatment Discontinuation/Failure Due to Toxicity(From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months))
• PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups(From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months))
• Percentage of Participants With DC in Biomarker-Positive Subgroup(From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months))
• DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups(From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months))
• Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)(Date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS (maximum up to approximately 26 months))
• Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score(Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months))