Adstiladrin (nadofaragene firadenovec-vncg)

P2, N=33, Not yet recruiting, University of Washington | Initiation date: Jun 2026 --> Sep 2026

In parallel, we highlight emerging intravesical immunotherapies for BCG-unresponsive NMIBC with carcinoma in situ, including nadofaragene firadenovec (Adstiladrin), nogapendekin alfa inbakicept-pmln (Anktiva), cretostimogene grenadenorepvec (CG0070), and detalimogene voraplasmid (EG-70). The lack of comparative data, coupled with the absence of predictive biomarkers of response, complicates treatment selection. Our review underscores that developing effective therapies for BCG-unresponsive disease will require combination strategies targeting multiple immune escape mechanisms that shape immune dynamics within the TME.

P3, N=53, Completed, Ferring Ventures Limited | Active, not recruiting --> Completed

P3, N=454, Recruiting, Ferring Pharmaceuticals | N=296 --> 454

P2, N=33, Not yet recruiting, University of Washington | Initiation date: Mar 2026 --> Jun 2026

Intermediate-risk patients could benefit from either intravesical chemotherapy or Bacillus Calmette-Guérin (BCG) instillation, with emerging therapies such as UGN-102 chemoablation showing promise...Moreover, alternative agents such as sequential gemcitabine and docetaxel instillation have demonstrated favorable outcomes in both BCG-naïve and BCG-unresponsive patients...Gene therapy (nadofaragene firadenovec), oncolytic viral therapy (CG0070), interleukin-15 superagonist (Nogapendekin alfa-inbakicept), and innovative drug delivery systems (TAR-200) have shown encouraging clinical potential in this population. This review provides an overview of current intravesical treatment strategies for NMIBC across different risk groups and highlights promising new approaches aimed at overcoming the limitations of BCG therapy.

P2/3, N=143, Recruiting, Ferring Pharmaceuticals A/S

P1/2, N=5, Not yet recruiting, Ferring Pharmaceuticals A/S

P=N/A, N=202, Terminated, Ferring Pharmaceuticals | N=400 --> 202 | Trial completion date: Dec 2027 --> Jan 2026 | Recruiting --> Terminated | Trial primary completion date: Dec 2027 --> Jan 2026; An internal audit identified major inconsistencies and missing data in key registry fields, including primary outcomes. These issues mean we can no longer ensure the validity of the primary endpoints.

P2, N=33, Not yet recruiting, University of Washington

P1, N=52, Recruiting, University of California, Davis | Not yet recruiting --> Recruiting | Trial completion date: Dec 2030 --> Feb 2030

Nadofaragene firadenovec, a recombinant adenovirus delivering interferon alpha-2b (IFNα2b), is the first FDA-approved gene therapy for BCG-unresponsive NMIBC with carcinoma in situ (CIS)...Cretostimogene grenadenorepvec (CG0070), an oncolytic vector, demonstrated a 47% 6-month CR rate in a phase II study (NCT02365818). Detalimogene voraplasmid (EG-70), a nonviral gene therapy, demonstrated a 47% 6-month CR in a phase I/II study (NCT04752722). Future advances are likely to focus on patient selection, novel vectors, and combination strategies to improve treatment outcomes. Gene therapy represents a significant addition to the bladder cancer treatment landscape by offering bladder-sparing alternatives where conventional therapies are limited.