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New treatment option for Intermediate Risk Non-Muscle Invasive Bladder Cancer
Official title Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT06510374
What this study is testing
What is Nadofaragene Firadenovec?
Nadofaragene Firadenovec is an investigational medicine, being studied as a potential treatment for intermediate risk non-muscle invasive bladder cancer.
Also referred to as Adstiladrin.
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
- A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of...
- Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to...
- Recurrence within 1 year, low-grade Ta
- Solitary low-grade Ta \>3 cm
- Low-grade Ta, multifocal
You likely can't join if
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit High risk NMIBC defined...
- High-grade T1
- Any recurrent, high-grade Ta
- High-grade Ta \>3 cm (or multifocal)
- Any carcinoma in situ (CIS)
- Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
See the full eligibility criteria
- Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology [SUO] Guideline (2020)
- Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
- Recurrence within 1 year, low-grade Ta
- Solitary low-grade Ta \>3 cm
- Low-grade Ta, multifocal
- Solitary high-grade Ta, ≤3 cm
- Low-grade T1
- Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.
- Restage TURBT may be done at the discretion of the investigator
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit High risk NMIBC defined as:
- High-grade T1
- Any recurrent, high-grade Ta
- High-grade Ta \>3 cm (or multifocal)
- Any carcinoma in situ (CIS)
- Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
- Any variant histology
- Any prostatic urethral involvement Low risk NMIBC defined as:
- First occurrence of low-grade solitary Ta ≤3 cm
- Recurrence of low-grade solitary Ta ≤3 cm \>12 months from previous occurrence
- Papillary urothelial neoplasm of low malignant potential
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Bakersfield, California, United States
- Fresno, California, United States
- Los Angeles, California, United States
- Murrieta, California, United States
- Orange, California, United States
- Santa Monica, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Largo, Florida, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Lisle, Illinois, United States
- Quincy, Illinois, United States
- Jeffersonville, Indiana, United States
- Clive, Iowa, United States
+ 76 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 Mobile, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Bakersfield, California, United States; Fresno, California, United States and 90 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.