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).
Diagnosed, as documented, with carcinoma in situ (CIS) ±Ta/T1 high-grade disease.
For T1 disease biopsies should contain muscle fibres.
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.
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
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
Parallel
Nadofaragene Firadenovec
Drugvector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification. It is a non-replicating recombinant adenovirus serotype 5 vector containing a transgene encoding the human IFN-α2b gene.
Gemcitabine
DrugIntravesical Gemcitabine chemotherapy, used in combination with Docetaxel.
Docetaxel
DrugIntravesical Docetaxel chemotherapy, used in combination with Gemcitabine.
Pembrolizumab
DrugPembrolizumab is an FDA approved immune checkpoint inhibitor which restores the anti-tumour immune response by blocking the programmed cell death protein 1 (PD-1). Pembrolizumab is administered via intravenous (IV) infusion.
Complete response
Complete response (CR) at any time from first treatment (defined as absence of high-grade (HG) recurrence).
Complete response at month 3
Complete response 3 months from first treatment
Complete response at month 6
Complete response 6 months from first treatment
Durability of complete response
Durability of complete response (defined as time from achieved CR to HG recurrence, progression or death due to any cause).
Muscle-invasive progression of disease
Muscle-invasive progression of disease (defined as time from first treatment to first evidence of muscle-invasive disease or death)
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