Is NCT07419295 recruiting in Germantown, TN?

Yes, NCT07419295 is currently recruiting participants at its Germantown, TN location. This bladder cancer clinical trial is actively enrolling qualified participants.

How do I join the bladder cancer clinical trial in Germantown?

To join this clinical trial in Germantown, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Germantown clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Bladder Cancer Clinical Trial in Germantown, TN

About This Bladder Cancer Study in Germantown

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.

Sponsor: Merck Sharp & Dohme LLC

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Germantown?

Yes, this clinical trial (NCT07419295) has an active research site in Germantown, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Bladder Cancer Treatment Options in Germantown, TN

If you're searching for bladder cancer treatment options in Germantown, TN, this clinical trial (NCT07419295) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Germantown research site is actively enrolling participants for this clinical trial. You'll receive care from experienced bladder cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all bladder cancer clinical trials near you to find additional studies recruiting in your area.

Bladder Cancer Clinical Trial in Germantown, TN

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