A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Particip
Primary Objective Part 1: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance treatment with bevacizumab Part 2: To compare sacituzumab tirumotecan maintenance treatment with or without bevacizumab to SoC (observation with or without bevacizumab) with respect to PFS per RECIST 1.1 as assessed by BICR Hypothesis (H1): Sacituzumab tirumotecan with or without bevacizumab is superior to SoC with respect to PFS per RECIST 1.1 as assessed by BICR in participants with medium + high TROP2 expression tumors Hypothesis (H2): Sacituzumab tirumotecan with or without bevacizumab is superior to SoC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants Secondary Objectives (Part 2) Part 2: To compare sacituzumab tirumotecan maintenance treatment with or without bevacizumab to SoC with respect to OS Hypothesis (H3): Sacituzumab tirumotecan with or without bevacizumab is superior to SoC with respect to OS in participants with medium + high TROP2 expression tumors Hypothesis (H4): Sacituzumab tirumotecan with or without bevacizumab is superior to SoC with respect to OS in all participants Part 2: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance treatment with or without bevacizumab Part 2: To evaluate sacituzumab tirumotecan maintenance treatment with or without bevacizumab versus SoC with respect to the mean change from baseline of global health status/QoL score using the EORTC QLQ-C30 and abdominal/GI symptoms using the EORTC QLQ-OV28 abdominal/GI symptom scale Tertiary/Exploratory Objectives Part 2: To evaluate PFS2 as determined by the investigator Part 2: To evaluate the time to first subsequent anticancer treatment (TFST) in participants with TROP2 high expressing tumors and all participants Part 2: To evaluate sacituzumab tirumotecan maintenance treatment with or without bevacizumab versus SoC with respect to TTD of global health status/QoL score using EORTC QLQ-C30 and abdominal/GI symptoms using EORTC QLQ-OV28 Part 2: To evaluate other health-related QoL scale scores of the EORTC QLQ-C30 and the EORTC QLQ-OV28 Part 2: To evaluate sacituzumab tirumotecan maintenance treatment with or without bevacizumab versus SoC with respect to mean change in the EQ-5D-5L VAS score Part 2: To identify molecular (genetic, metabolic, and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of sacituzumab tirumotecan Parts 1 and 2: To characterize the PK and incidence of ADA of sacituzumab tirumotecan