A Phase III, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced non-HRD positive Ovarian Cancer Following First-line Platinum- based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: III
Principal Investigator: McAlarnen, Lindsey
Contact Information:
Evelyn Cantril, CRA
402-559-7507
ecantril@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07318558?term=GOG-3102&rank=1&tab=study#participation-criteria
Summary
-To compare sac-TMT maintenance treatment with or without bevacizumab to SoC, with respect to PFS per RECIST 1.1 as assessed by BICR.
-Hypothesis (H1): sac-TMT with or without bevacizumab is superior to SoC with respect to PFS as assessed by BICR in participants with TROP2 medium + high expression tumors.
-Hypothesis (H2): sac-TMT with or without bevacizumab is superior to SoC with respect to PFS as assessed by BICR in all participants.
-To compare sac-TMT maintenance treatment with respect to OS.
-Hypothesis (H3): sac-TMT with or without bevacizumab is superior to SoC with respect to OS in participants with TROP2 medium + high expression tumors.
-Hypothesis (H4): sac-TMT with or without bevacizumab is superior to SoC with respect to OS in all participants.
-To evaluate the safety and tolerability of sac-TMT maintenance treatment with or without bevacizumab.
-To evaluate sac-TMT maintenance treatment with or without bevacizumab versus SoC with respect to the mean change from baseline of GHS/QoL score using the EORTC QLQ-C30 and abdominal/GI symptoms using the EORTC QLQ-OV28 abdominal/GI symptom scale.
-To evaluate other health-related QoL scale scores of the EORTC QLQ C30 and the EORTC QLQ-OV28.
-To evaluate sac-TMT maintenance treatment with or without bevacizumab versus SoC with respect to TTD or GHS/QoL score using EORTC QLQ-C30 and abdominal/GI symptoms using EORTC QLQ-OV28.
-To evaluate sac-TMT maintenance treatment with or without bevacizumab versus SoC with respect to mean change in the EQ-5D-5L VAS score.
-To evaluate the TFST.
-To identify molecular (genetic, metabolic and/or proteomic) biomarkers that may be indicative of clinical response/resistance, pharmacodynamic activity, and/or the mechanism of action of sac-TMT.
-To characterize the PK and incidence of ADA of sac-TMT.