Advanced solid tumors
Conditions
Brief summary
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR), Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR, ORR per RECIST 1.1 as Assessed by Investigator, PFS per RECIST 1.1 as Assessed by Investigator at 9 months, PFS per RECIST 1.1 as Assessed by Investigator at 12 months
Detailed description
Overall Survival (OS), PFS per RECIST 1.1 as Assessed by Investigator, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, DOR per RECIST 1.1 as Assessed by Investigator, ORR per RECIST 1.1 as Assessed by Investigator, Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30), Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5), Number of Participants Who Experienced One or More Adverse Events (AEs)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR), Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR, ORR per RECIST 1.1 as Assessed by Investigator, PFS per RECIST 1.1 as Assessed by Investigator at 9 months, PFS per RECIST 1.1 as Assessed by Investigator at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS), PFS per RECIST 1.1 as Assessed by Investigator, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, DOR per RECIST 1.1 as Assessed by Investigator, ORR per RECIST 1.1 as Assessed by Investigator, Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30), Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5), Number of Participants Who Experienced One or More Adverse Events (AEs) | — |
Countries
France, Germany, Italy, Netherlands, Poland, Spain