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New treatment option for Bladder Cancer
Official title A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
ClinicalTrials.gov ID: NCT07419295
What this study is testing
What is Sacituzumab tirumotecan?
Sacituzumab tirumotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bladder cancer.
Also referred to as MK-2870, SKB264.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main 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...
- 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...
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
- The main 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Traverse City, Michigan, United States
- Cincinnati, Ohio, United States
- Germantown, Tennessee, United States
- Knoxville, Tennessee, United States
- Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Rosario, Santa Fe Province, Argentina
- Macquarie, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Brussels, Bruxelles-Capitale, Region de, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Liège, Belgium
- Curitiba, Paraná, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São José do Rio Preto, São Paulo, Brazil
- Québec, Quebec, Canada
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Zhuhai, Guangdong, China
- Wuhan, Hubei, China
+ 42 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Traverse City, Michigan, United States; Cincinnati, Ohio, United States; Germantown, Tennessee, United States; Knoxville, Tennessee, United States; Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina; Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina and 56 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.