No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
590 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for
This trial is looking for people with bladder cancer that has spread or got worse after previous treatments. Participants will receive a new treatment called sacituzumab tirumotecan and be compared to those receiving standard chemotherapy options.
Are You a Good Fit for This Trial?
You may be able to join if
I have locally advanced or metastatic bladder cancer
I have measurable disease as confirmed by my doctor
I have been treated with anti-PD-L1 therapy and platinum-based chemotherapy
I have received no more than 2 prior lines of therapy
I have disease progression after my last treatment
I have an ECOG performance status of 0 or 1
I can provide a tissue sample or tumor biopsy
I have well-controlled HIV or hepatitis B/C
You may not be able to join if
I have severe dry eye syndrome or corneal disease
I have uncontrolled significant heart or brain disease
I have a history of interstitial lung disease or pneumonitis
I have received anticancer therapy in the last 4 weeks
I have had previous treatment with a TROP2-targeted therapy
I have had radiation therapy recently or have radiation-related side effects
I have had a major surgery recently or have surgical complications
I have an active infection requiring systemic therapy
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 goa…
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment
* Ha…
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment
* Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator
* Has received treatment with anti-programmed cell death \[ligand\] 1 (anti-PD-\[L\]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)
* Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry
* Has received a maximum of 2 prior lines of therapy
* Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
* Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine)
* Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated
* If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART)
* If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load
* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
* Has adequate organ function
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy
* Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC)
* Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC
* Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine)
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has a current or past history of central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active infection requiring systemic therapy other than those permitted per protocol
* Has a history of stem cell/solid organ transplant
* Has not adequately recovered from major surgery, or has ongoing surgical complications
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