A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator’s Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy
Phase 3 – large-scale trial before approval
Conditions:
Endometrial Cancer
Advanced
Recurrent
Metastatic
or Primary Unresectable Endometrial Cancer
Sponsor: Genmab A/S
trial.available_in:
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Overview
Trial status: Authorised
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
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]
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
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female
Target enrollment: 226 participants
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