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New treatment option for Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Official title A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT06545955
What this study is testing
What is Nadofaragene Firadenovec?
Nadofaragene Firadenovec is an investigational medicine, being studied as a potential treatment for non-muscle invasive bladder cancer with carcinoma in situ.
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
- 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).
- Phase 3: a large, late-stage study
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, 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...
- 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...
- 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
You likely can't join if
- Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased...
- Presence of lymphovascular invasion and / or micropapillary, sarcomatoid, plasmacytoid and / or neuroendocrine disease as shown in the histology of...
- 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...
- Current or prior pelvic external beam radiotherapy within 2 years of screening
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- Male people 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.
- 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 treatment study does not apply) within 1...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Diego, California, United States
- Denver, Colorado, United States
- Lakewood, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Boise, Idaho, United States
- Lisle, Illinois, United States
- Indianapolis, Indiana, United States
- Wichita, Kansas, United States
- Annapolis, Maryland, United States
- Hanover, Maryland, United States
- Morristown, New Jersey, United States
- Buffalo, New York, United States
- Cheektowaga, New York, United States
+ 47 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 Tucson, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; San Diego, California, United States; Denver, Colorado, United States and 61 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.