ADSTILADRIN

DRUG5 trials

Sponsors

Ferring Pharmaceuticals A/S, Ferring Pharmaceuticals

Conditions

Bladder CancerHigh-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ(CIS) with or without papillary tumoursIntermediate riskLow-grade upper track urothelial carcinoma (LG-UTUC)Superficial Bladder Cancernon-muscle invasive bladder cancer

Phase 1

A Phase 1/2, Single-arm, Open-Label Trial to Evaluate the Safety and Efficacy of Nadofaragene Firadenovec Instilled to the Renal Pelvis in Adult Subjects with Low-Grade Upper Tract Urothelial Carcinoma (LG-UTUC)

Not yet recruitingCTIS2024-514360-70-00

Ferring Pharmaceuticals A/SLow-grade upper track urothelial carcinoma (LG-UTUC)

Target: 5Updated: 2025-09-22

Phase 3

ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

CompletedNCT02773849

Ferring PharmaceuticalsSuperficial Bladder Cancer

Start: 2016-09-19End: 2023-05-24Updated: 2024-07-29

A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Subjects with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

RecruitingCTIS2024-512029-10-00

Ferring Pharmaceuticals A/SIntermediate risk, non-muscle invasive bladder cancer

Start: 2025-12-05Target: 253Updated: 2026-01-16

A phase 3, randomised, multi-center, open label trial to evaluate the safety and efficacy of intravesical nadofaragene firadenovec alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in subjects with high-grade Bacillus Calmette-Guerin therapy (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC)

RecruitingCTIS2024-512177-27-01

Ferring Pharmaceuticals A/SHigh-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ(CIS) with or without papillary tumours

Start: 2025-09-29Target: 143Updated: 2026-01-26

Unknown Phase

ADSTILADRIN Early Utilization and Outcomes in the Real World Setting

TerminatedNCT06026332

Ferring PharmaceuticalsBladder Cancer

Start: 2023-09-15End: 2026-01-15Updated: 2026-02-17

Related Papers

Gene Therapy for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Current Evidence and Future Directions.

2025-11-12

ABLE-41, a real-world evidence study for bladder cancer patients treated with nadofaragene firadenovec: Baseline patient characteristics and demographics.

Journal of Clinical Oncology2025-05-282 citations

Safety of nadofaragene firadenovec-vncg: review of data from phase 2 and phase 3 studies.

2025-03-01

Cost effectiveness analysis of nadofaragene firadenovec for the treatment of high-risk, bacillus Calmette-Guerin–unresponsive, non-muscle invasive bladder cancer from a US third-party payer perspective.

Journal of Clinical Oncology2024-06-01

Efficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin-Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial.

2024-05-0547 citations

PD48-01 EFFICACY OF NADOFARAGENE FIRADENOVEC-VNCG FOR PATIENTS WITH BACILLUS CALMETTE-GUÉRIN-UNRESPONSIVE NON-MUSCLE-INVASIVE BLADDER CANCER: FINAL RESULTS FROM A PHASE 3 TRIAL

The Journal of Urology2024-04-15

ABLE-41: Nadofaragene firadenovec-vncg early use and outcomes in a real-world setting in the United States.

Journal of Clinical Oncology2024-01-293 citations

MP54-05 EVALUATING INTRAVESICAL NADOFARAGENE FIRADENOVEC AND IMMUNE CHECKPOINT BLOCKADE COMBINATION THERAPY IN BCG-UNRESPONSIVE NON-MUSCLE-INVASIVE BLADDER CANCER: EVIDENCE FROM A PHASE 3 TRIAL

The Journal of Urology2022-04-071 citations

MP16-01 EFFICACY OF INTRAVESICAL NADOFARAGENE FIRADENOVEC FOR PATIENTS WITH CARCINOMA IN SITU (CIS), BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC): LONGER-TERM FOLLOW-UP FROM THE PHASE III TRIAL

The Journal of Urology2021-08-044 citations

MP16-02 PHASE III TRIAL OF INTRAVESICAL NADOFARAGENE FIRADENOVEC IN PATIENTS WITH HIGH-GRADE, BCG-UNRESPONSIVE, NON-MUSCLE INVASIVE BLADDER CANCER: TWO YEAR FOLLOW-UP IN THE TA/T1 COHORT

The Journal of Urology2021-08-044 citations

PD09-02 ANTI-ADENOVIRAL ANTIBODY LEVELS PREDICT NADOFARAGENE FIRADENOVEC RESPONSE IN BCG-UNRESPONSIVE NMIBC: RESULTS FROM A PHASE 3 TRIAL

The Journal of Urology2021-08-04

Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial.

2020-11-27314 citations

PD12-07 A PHASE III STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVESICAL NADOFARAGENE FIRADENOVEC FOR PATIENTS WITH HIGH-GRADE, BCG UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER

The Journal of Urology2020-04-018 citations

Safety and efficacy of intravesical nadofaragene firadenovec for patients with high-grade, BCG unresponsive nonmuscle invasive bladder cancer (NMIBC): Results from a phase III trial.

Journal of Clinical Oncology2020-02-1914 citations

Precision Medicine in Bladder Cancer

Oncology Times2019-05-31