Summary:
This study is investigating the study drug nadofaragene firadenovec, alone or in combination with other study drugs, as a possible treatment for your cancer type, that is, high-grade non-muscle invasive bladder cancer.
Qualified Participants Must:
1. Signed informed consent obtained before beginning any trial-related procedures
2. Diagnosed, as documented, with carcinoma in situ (CIS) ±Ta/T1 high-grade disease
3. Unresponsive to ≥2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last
12 months. BCG-unresponsive refers to subjects 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 subjects 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 (CR) to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with highgrade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.
The following criteria define the subjects 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.
- 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, subjects 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
Qualified Participants May Receive:
Study medication and To help support your participation in this study, you will receive a stipend for $150.00 per completed protocol required study visit.