A Phase 3, 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)
Summary
Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include: * Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. * Observation, which is watching to see if cancer grows or worsens The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.
Arms & interventions
- DrugSacituzumab tirumotecan
Administered via intravenous (IV) infusion at a dose of 4mg/kg
- DrugBevacizumab
Administered via IV infusion at a dose of 15mg/kg
- DrugRescue Medications
Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.
Outcome measures
Primary
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Time frame: Up to approximately 49 months
Secondary
Overall Survival (OS)
Time frame: Up to approximately 78 months
Progression-Free Survival 2 (PFS2)
Time frame: Up to approximately 78 months
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 78 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 78 months
Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Baseline, and at designated time points up to approximately 78 months
Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30
Time frame: Baseline, and at designated time points up to approximately 78 months
Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30
Time frame: Baseline, and at designated time points up to approximately 78 months
Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)
Time frame: Baseline, and at designated time points up to approximately 78 months
Eligibility criteria
Study locations (9)
Mount Sinai Cancer Center ( Site 0029)
Miami Beach, Florida, 33140
Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)
Orlando, Florida, 32806
Winship Cancer Institute of Emory University ( Site 0037)
Atlanta, Georgia, 30308
Parkview Research Center at Parkview Regional Medical Center ( Site 0055)
Fort Wayne, Indiana, 46845
Women's Cancer Care ( Site 0018)
Covington, Louisiana, 70433
Nebraska Methodist Hospital ( Site 0004)
Omaha, Nebraska, 68114
University Of Nebraska Medical Center ( Site 0035)
Omaha, Nebraska, 68198
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)
Tulsa, Oklahoma, 74146
West Cancer Center and Research Institute ( Site 0013)
Germantown, Tennessee, 38138