West Cancer Center

BLADDER: METASTATIC: 2nd Line: TroFuse-031

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

Title

Merck MK-2870-031 2nd Line Bladder

Study Title

Site Link

NCT07419295

Malignancy

Bladder cancer, Urothelial cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line or later

Investigational Agent

Sacituzumab Tirumotecan (sac-TMT)

Drug Class

Topo-2 targeted Antibody drug conjugate

Brad Somer, MD

Sponsor

Merck Sharp and Dohme

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent
Measurable disease
Must have had prior treatment with anti PD-(L)1 therapy, platinum based therapy, and enfortumab vedotin
No more than 2 prior lines of therapy
ECOG PS 0-1
No active HBV/HCV/HIV but well controlled disease is allowed
No severe corneal disease
No prior TROP2-targeted ADC
No prior therapy with paclitaxel, docetaxel, or vinflunine
No chronic steroid usage

Objective

Primary
- OS
Secondary
- PFS
- ORR
- DOR
- Safety
- QOL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Urothelial carcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes