New Haven, CTNCT07048457Now EnrollingIRB Ready

Locally Advanced Urothelial Carcinoma Clinical Trial in New Haven, CT

Access cutting-edge locally advanced urothelial carcinoma treatment through this clinical trial at a research site in New Haven. Study-provided care at no cost to qualified participants.

Sponsored by Yale University

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Expert Care in New Haven

Access locally advanced urothelial carcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related locally advanced urothelial carcinoma treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to New Haven

    Convenient for CT residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New Haven site if eligible
  4. 4Begin participation

About This Locally Advanced Urothelial Carcinoma Study in New Haven

This study investigates the therapeutic benefit of consolidative local therapy with extirpative surgery for participants with locally advanced or oligo-metastatic urothelial carcinoma that have disease control with enfortumab vedotin-based systemic therapy and surgically resectable or previously radiated metastatic sites.

Sponsor: Yale University

Who Can Participate

Inclusion Criteria

Be at least 18 years of age.
Have provided informed consent.
Have ECOG Performance status of 0 or 1.
Be surgical candidate for extirpative surgery of primary site with standard bilateral pelvic lymph node dissection and urinary diversion at the discretion of urological oncologist.
If applicable, must be a surgical candidate for resection of non-irradiated metastatic lesion(s) at the discretion of the treating surgeon.
Have adequate organ function as defined by:
Hgb \>9.0 ng/dL.
WBC \>3.0 K/mcL.
PLT \>100 K /mcL.
AST \<3.0 x ULN U/L.
ALT \<3.0 x ULN U/L.
Total Bilirubin \<2.0 x UNL mg/dL. Disease characteristics:
Have histologically confirmed diagnosis of locally advanced or oligo-metastatic urothelial carcinoma defined by presence of five or few distinct metastatic lesions at the time of diagnosis of metastatic disease.
If variant histology present, it must be \<50% and UC must be predominant.
Must have begun the first cycle of enfortumab-vedotin-based first-line therapy at least three months prior to the surgery and have continued therapy and the treatment duration must have not exceeded six months from the start of the first cycle. Treatment interruption, modification and discontinuation due to adverse events are allowed. Metastasis-directed radiotherapy (MDRT) is allowed.
The most recent restaging scan prior to signing ICD must show stable disease, partial response or complete response per treating investigator-assessed RECIST v1.1. In case of stable disease or partial response, MDRT is highly recommended. Enrollment of such participants should be discussed with the PI.

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from study entry.
Received systemic anti-cancer therapy within three weeks prior to the surgery.
Received radiotherapy within two weeks prior to the surgery.
Have a positive serum pregnancy test or women who are breastfeeding.
Have other concurrent medical, surgical or psychiatric conditions that, in the treating investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
Have any medical condition that, in the treating investigator's opinion, poses an undue risk to the participant's participation in the study.
Have history of central nervous system (CNS) metastasis and/or leptomeningeal metastasis.

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 New Haven?

Yes, this clinical trial (NCT07048457) has an active research site in New Haven, CT 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.

Locally Advanced Urothelial Carcinoma Treatment Options in New Haven, CT

If you're searching for locally advanced urothelial carcinoma treatment options in New Haven, CT, this clinical trial (NCT07048457) 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 New Haven research site is actively enrolling participants for this clinical trial. You'll receive care from experienced locally advanced urothelial carcinoma 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 locally advanced urothelial carcinoma clinical trials near you to find additional studies recruiting in your area.

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