Sacituzumab Tirumotecan for Bladder Cancer

(TroFuse-031 Trial)

Recruiting at 26 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Anti-PD-L1, Platinum-based, Enfortumab vedotin

Must not be taking: TROP2-targeted ADC, Topoisomerase 1 ADC

Disqualifiers: Severe eye disease, Cardiovascular disease, Pneumonitis, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Up to approximately 40 months

590 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

I have advanced or metastatic urothelial cancer that cannot be cured with surgery or radiation.

I can safely receive at least one of the listed chemotherapy drugs.

I have hepatitis B and my viral load is undetectable after at least 4 weeks of treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab tirumotecan or non-platinum chemotherapy until disease progression or unacceptable toxicity

Up to approximately 40 months

Every 2 weeks for sacituzumab tirumotecan, every 3 weeks for chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 49 months

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab Tirumotecan

How Is the Trial Designed?

Group I: Sacituzumab tirumotecan Experimental Treatment 2 Interventions

Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity.

Group II: Chemotherapy Active Control 4 Interventions

Participants receive paclitaxel 175 mg/m\^2, docetaxel 75 mg/m\^2, or vinflunine 320 mg/m\^2 IV every 3 weeks (Q3W), at the investigator's discretion, until disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University