A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma
Summary
Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy. Researchers want to know if giving sacituzumab tirumotecan (sac-TMT), the trial medicine, can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies.
Arms & interventions
- BiologicalSacituzumab tirumotecan
IV infusion
- DrugVinflunine
IV infusion
- DrugDocetaxel
IV infusion
- DrugPaclitaxel
IV infusion
- DrugRescue medications for sacituzumab tirumotecan
Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).
- DrugRescue medications for chemotherapy
Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are dexamethasone or equivalent, H1 receptor antagonist, H2 receptor antagonist, and laxative.
Outcome measures
Primary
Overall Survival (OS)
OS is defined as time from randomization to death due to any cause.
Time frame: Up to approximately 40 months
Secondary
Progression-Free Survival (PFS)
Time frame: Up to approximately 32 months
Objective Response Rate (ORR)
Time frame: Up to approximately 32 months
Duration of Response (DOR)
Time frame: Up to approximately 49 months
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 49 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 48 months
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
Time frame: Baseline, up to approximately 49 months
Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Time frame: Baseline, up to approximately 49 months
Change From Baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Time frame: Baseline, up to approximately 49 months
Change From Baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score
Time frame: Baseline, up to approximately 49 months
Change From Baseline in EORTC QLQ-C30 Nausea/Vomiting (Items 14 and 15) Combined Score
Time frame: Baseline, up to approximately 49 months
Change From Baseline in EORTC QLQ-C30 Diarrhea (Item 17) Score
Time frame: Baseline, up to approximately 49 months
Eligibility criteria
Study locations (3)
Munson Medical Center ( Site 0812)
Traverse City, Michigan, 49684
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
Cincinnati, Ohio, 45220
Thompson Cancer Survival Center ( Site 0803)
Knoxville, Tennessee, 37916