Is NCT06545955 recruiting in Little Rock, AR?

Yes, NCT06545955 is currently recruiting participants at its Little Rock, AR location. This bladder cancer clinical trial is actively enrolling qualified participants.

How do I join the bladder cancer clinical trial in Little Rock?

To join this clinical trial in Little Rock, 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 Little Rock 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 Little Rock, AR

About This Bladder Cancer Study in Little Rock

The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).

Sponsor: Ferring Pharmaceuticals

Who Can Participate

Inclusion Criteria

Diagnosed, as documented, with carcinoma in situ (CIS) ±Ta/T1 high-grade disease.

For T1 disease biopsies should contain muscle fibres.

Unresponsive to ≥2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last 12 months. BCG-unresponsive refers to participants with high-grade non-muscle invasive bladder cancer (NMIBC) who are unlikely to benefit from and who will not be receiving further intravesical BCG. The term "BCG-Unresponsive" includes participants who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. The following criteria define the participants who may be included in the trial:

Have received at least 2 courses of BCG within a 12 month period - defined as at least 5 of 6 induction BCG instillations and at least 2 of 3 instillations of maintenance BCG, or at least 2 of 6 instillations of a second induction course, where maintenance BCG is not given. o Exception: those who have T1 high-grade disease at 1st evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression

At the time of tumour recurrence, participants with CIS alone or high-grade Ta/T1 with CIS should be within 12 months of last exposure to BCG

No maximum limit to the amount of BCG administered

All visible papillary tumours must be resected and those with persistent T1 disease on transurethral resection of bladder tumour (TURBT) should undergo an additional re-TURBT within 14 to 70 days prior to beginning trial treatment. Obvious areas of CIS should also be fulgurated

Eastern Cooperative Oncology Group (ECOG) status ≤2

Aged ≥18 years at the time of consent

Available for the whole duration of the trial

Life expectancy \>2 years, in the opinion of the investigator

Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumour by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or magnetic resonance imaging (MRI) with or without urogram performed within 6 months of enrolment. Absence of locally advanced disease as assessed by CT scan or MRI

Participants who elect not to undergo cystectomy

Participants with prostate cancer on active surveillance at low risk for progression are permitted to be included into the trial at the discretion of the investigator

Females of reproductive potential must have a negative highly sensitive urine or serum pregnancy test upon entry into this trial and be willing to use highly effective contraception during treatment with the investigational medicinal product and for 6 months following the last dose. Otherwise, female participants must be post-menopausal (no menstrual period for a minimum of 12 months, as confirmed by follicle-stimulating hormone levels) or surgically sterile

Male subjects must be willing to use a male condom and effective contraception during sex throughout the treatment period and for 3 months following the last dose.

Exclusion Criteria

Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive disease include but are not limited to:

Presence of lymphovascular invasion and / or micropapillary, sarcomatoid, plasmacytoid and / or neuroendocrine disease as shown in the histology of the biopsy sample

Participants with CIS+T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumour

Current systemic therapy for bladder cancer other than investigational medicinal products used in randomisation arm

Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non interventional study does not apply) within 1 month prior to screening

Current or prior pelvic external beam radiotherapy within 2 years of screening

Prior treatment with nadofaragene firadenovec at any time

Prior systemic therapy for bladder cancer at any time

Prior intravesical chemotherapy for the treatment of BCG-unresponsive NMIBC

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 Little Rock?

Yes, this clinical trial (NCT06545955) has an active research site in Little Rock, 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.

Bladder Cancer Treatment Options in Little Rock, AR

If you're searching for bladder cancer treatment options in Little Rock, AR, this clinical trial (NCT06545955) 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 Little Rock research site is actively enrolling participants for this phase 3 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 Little Rock, AR

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