Endometrial Cancer Advanced, Metastatic, or Primary Unresectable Endometrial Cancer, Recurrent
Conditions
Brief summary
1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by independent central review (BICR) [Time Frame: Up to approximately 3 years], 2. Overall Survival (OS) [Time Frame: Up to approximately 3 years]
Detailed description
Objective Response Rate (ORR), per RECIST v1.1, as Determined by BIRC, PFS, per RECIST v1.1, as determined by investigator assessment, ORR, per RECIST v1.1, as Determined by investigator assessment, Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment, DOR, per RECIST v1.1, as Determined by BICR, Number of Participants with Treatment-emergent Adverse Events (TEAEs), Change from Baseline in Global Health Status/Quality of Life (GHS/Qol), Time to Deterioration (TTD) in GHS/Qol
Interventions
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by independent central review (BICR) [Time Frame: Up to approximately 3 years], 2. Overall Survival (OS) [Time Frame: Up to approximately 3 years] | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR), per RECIST v1.1, as Determined by BIRC, PFS, per RECIST v1.1, as determined by investigator assessment, ORR, per RECIST v1.1, as Determined by investigator assessment, Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment, DOR, per RECIST v1.1, as Determined by BICR, Number of Participants with Treatment-emergent Adverse Events (TEAEs), Change from Baseline in Global Health Status/Quality of Life (GHS/Qol), Time to Deterioration (TTD) in GHS/Qol | — |
Outcome results
None listed