BridgeMD
New treatment option for Low-grade Upper Tract Urothelial Carcinoma
Official title Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis
ClinicalTrials.gov ID: NCT06668493
What this study is testing
What is Nadofaragene Firadenovec?
Nadofaragene Firadenovec is an investigational medicine, being studied as a potential treatment for low-grade upper tract urothelial carcinoma.
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 primary purpose of this trial is to evaluate the safety \& tolerability of Nadofaragene Firadenovec in subjects with LG-UTUC. To help with this evaluation, a safety lead-in period will be conducted for the first 6 subjects.
- Phase 2: a mid-size study of how well it works
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
- Aged ≥18 years at the time of signing informed consent.
- Able to give written informed consent.
- Have biopsy-proven low-grade upper tract urothelial cancer (LG-UTUC) confirmed by a pathology report ≤2 months prior to enrolment.
- Have ≥1 measurable papillary low-grade tumour (5-15 mm in maximum diameter), evaluated visually above the ureteropelvic junction before enrolment.
- people with low-grade tumour larger than 15 mm will be eligible if endoscopic downsizing of the tumour to 5-15 mm in maximum diameter has been...
You likely can't join if
- #20]). Exclusion Criteria:
- UTUC characterised by one or more of the following:
- High-grade cytology or high-grade histology
- Multi-focal UTUC
- Exception: people with low-grade multi-focal tumours will be eligible if any ureteral tumours can be ablated before enrolment and if the total...
- Bilateral disease
See the full eligibility criteria
- Aged ≥18 years at the time of signing informed consent.
- Able to give written informed consent.
- Have biopsy-proven low-grade upper tract urothelial cancer (LG-UTUC) confirmed by a pathology report ≤2 months prior to enrolment.
- Have ≥1 measurable papillary low-grade tumour (5-15 mm in maximum diameter), evaluated visually above the ureteropelvic junction before enrolment.
- people with low-grade tumour larger than 15 mm will be eligible if endoscopic downsizing of the tumour to 5-15 mm in maximum diameter has been performed before enrolment.
- Willing to be available for at least 18 months after first dosing.
- Have life expectancy \>2 years, in the opinion of the investigator.
- Have an Eastern Cooperative Oncology Group (ECOG) status of 2 or less.
- 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 with female partners of reproductive potential must be surgically sterile or willing to use a condom in addition to effective contraception in their female partner during treatment with the IMP and for 3...
- Adequate laboratory values:
- haemoglobin ≥10 g/dL
- white blood cells (WBC) ≥4000/μL
- absolute neutrophil count (ANC) ≥2000/μL
- platelet count ≥100,000/μL
- international normalized ratio (INR)\ below institutional upper limit of normal (ULN)
- activated partial thromboplastin time (aPTT)\ below institutional ULN
- aspartate aminotransferase (AST) ≤1.5 x ULN
- alanine aminotransferase (ALT) ≤1.5 x ULN
- total bilirubin ≤1.5 x ULN
- sodium \>135 mmol/L
- potassium between 3.6 and 5.0 mmol/L
- Have an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 (for inclusion in the safety lead-in the eGFR must be ≥60 mL/min/1.73 m2 [see
- #20]). Exclusion Criteria:
- UTUC characterised by one or more of the following:
- High-grade cytology or high-grade histology
- Multi-focal UTUC
- Exception: people with low-grade multi-focal tumours will be eligible if any ureteral tumours can be ablated before enrolment and if the total diameter of the multifocal tumours above the ureteropelvic junction is not...
- Bilateral disease
- Exception: people who have had bilateral disease are eligible (not in the safety lead-in) if one renal unit is removed or rendered disease-free by endoscopic ablation before enrolment.
- Current or previous evidence of carcinoma in situ, of muscle invasive (muscularis propria) urothelial cancer in the urogenital tract presented at the screening visit.
- Concomitant lower tract urothelial carcinoma and/or concomitant or prior urothelial carcinoma within the prostatic urethra.
- History of high grade papillary urothelial cancer within 2 years prior to screening.
- Current or prior treatment with mitomycin gel and/or any investigational drug for the treatment of UTUC.
- Current systemic chemo- or immunotherapy for bladder cancer or any other malignancy.
- Current or prior investigational treatment for Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) or any other investigational drug within 1 month prior to screening.
- Current or prior retroperitoneal external beam radiotherapy within 5 years of screening.
- Prior treatment with adenovirus-based drugs including use of other adenovirus vector medications, including COVID-19 vaccines, within 2 weeks before instillation.
- Suspected and/or a medical history of hypersensitivity to nadofaragene firadenovec, interferon-α2b (IFN-α2b) and/or adenovector medications.
- Urinary tract infection or bacterial cystitis (once satisfactorily treated, people can enter the trial).
- Clinically significant and unexplained elevated liver or renal function tests at screening.
- Women who are pregnant (highly sensitive urine or serum pregnancy test at screening) or breastfeeding.
- Any other significant disease or other clinical findings which in the opinion of the investigator would prevent trial entry.
- History of malignancy in any other organ system than the upper urinary tract within the past 5 years prior to screening. However, people with the following exceptions will be allowed inclusion in the trial:
- Treated basal cell carcinoma or squamous cell carcinoma of the skin.
- History of ≤pT2 upper tract urothelial carcinoma, at least 24 months after radical nephroureterectomy (RNU).
- Cervical intraepithelial carcinoma (CIN) without evidence of invasive carcinoma.
- Prostate cancer that is under active surveillance or urothelial cancer. All other genitourinary cancers are excluded.
- Inability to deliver IMP to the pyelocaliceal system.
- Previous BCG treatment during 6 months before the initiation of treatment.
- Any immunosuppressive therapy within 3 months prior to screening.
- people who are immunocompromised or immunodeficient at screening.
- people with solitary kidney and/or an eGFR \<60 mL/min/1.73 m2 (only applicable for people in the safety lead-in period).
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Santa Monica, California, United States
- Jacksonville, Florida, United States
- Indianapolis, Indiana, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
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 Scottsdale, Arizona, United States; Santa Monica, California, United States; Jacksonville, Florida, United States; Indianapolis, Indiana, United States; Rochester, Minnesota, United States; New York, New York, United States and 2 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.