Hot Springs, ARNCT07720284Now EnrollingIRB Ready

High-risk Muscle Invasive Urothelial Carcinoma Clinical Trial in Hot Springs, AR

Access cutting-edge high-risk muscle invasive urothelial carcinoma treatment through this phase 3 clinical trial at a research site in Hot Springs. Study-provided care at no cost to qualified participants.

Sponsored by AstraZeneca

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Expert Care in Hot Springs

Access high-risk muscle invasive urothelial carcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related high-risk muscle invasive urothelial carcinoma treatment provided free

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Check if you qualify for this high-risk muscle invasive urothelial carcinoma clinical trial in Hot Springs, AR

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Why Participate?

  • No-Cost Study Care

  • Local to Hot Springs

    Convenient for AR 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 Hot Springs site if eligible
  4. 4Begin participation

About This High-risk Muscle Invasive Urothelial Carcinoma Study in Hot Springs

Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection. Study details: Duration: \~78 months (6.5 years) from FSI to last subject visit Treatment length: up to \~12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3

Sponsor: AstraZeneca

Who Can Participate

Inclusion Criteria

Participant must be \> 18 years of age at the time of signing the ICF.
Histologically confirmed MIUC of the bladder or upper tract.
Completed R0 radical resection 28 to 120 days before randomisation, with negative margins and no residual or metastatic disease.
Pathologic evidence of urothelial carcinoma at high-risk of recurrence and
not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage
completed neoadjuvant treatment and has ypT2-ypT4a, or any ypT with ypN+ stage
No evidence of disease at screening,
ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
Minimum life expectancy of \> 12 weeks at time of screening.
An archival surgical tumour sample must be available pre-randomisation for central testing.
Adequate organ and bone marrow function within 28 days before randomisation.

Exclusion Criteria

Any tumour with predominant or pure high grade neuroendocrine carcinoma component.
Partial cystectomy in the setting of bladder cancer primary tumour or partial nephrectomy.
Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma.
Severe or uncontrolled systemic diseases, history of organ transplant or allogeneic stem cell transplant, or psychological disorders/social situations, and/or substance abuse.
History of clinically significant corneal disease.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention and of low potential risk for recurrence.
Ongoing toxicities except alopecia from prior cancer treatment must be Grade ≤ 1 or at baseline. Stable Grade 2 toxicities are allowed if unchanged for ≥3 months and managed by standard care.
Active or uncontrolled hepatitis B or C virus infection.
Known HIV infection that is not well controlled.
Any other active or uncontrolled infection including tuberculosis requiring systemic treatment that has not resolved by the time of randomisation.
History of non-infectious ILD/pneumonitis including radiation, pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
Has clinically severe pulmonary function compromise.
Mean resting corrected QTcF \> 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening
Uncontrolled or significant cardiac conditions.
Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment in the past 5 years.
Prior exposure to TROP2-directed therapies, other ADCs with deruxtecan, therapeutic anti-cancer vaccines, anti-TIGIT therapy or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms.
Current or prior use of immunosuppressive medication within 14 days prior to treatment assignment/randomisation.
Known history of severe hypersensitivity reactions to any study drug
Not eligible to receive at least one of SoC according to local regulations/approvals.
Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

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 Hot Springs?

Yes, this clinical trial (NCT07720284) has an active research site in Hot Springs, AR 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.

High-risk Muscle Invasive Urothelial Carcinoma Treatment Options in Hot Springs, AR

If you're searching for high-risk muscle invasive urothelial carcinoma treatment options in Hot Springs, AR, this clinical trial (NCT07720284) 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 Hot Springs research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced high-risk muscle invasive 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 high-risk muscle invasive urothelial carcinoma clinical trials near you to find additional studies recruiting in your area.

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