Nadofaragene Firadenovec

DRUG6 trials

Sponsors

Ferring Pharmaceuticals, Memorial Sloan Kettering Cancer Center, University of Washington

Conditions

Bladder CancerCISIntermediate Risk Non-Muscle Invasive Bladder CancerLow-grade Upper Tract Urothelial CarcinomaMuscle Invasive Bladder Urothelial CarcinomaNon-Muscle Invasive Bladder CancerNon-muscle Invasive Bladder Cancer With Carcinoma in SituStage II Bladder Cancer AJCC v8

Phase 1

Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis

RecruitingNCT06668493

Ferring PharmaceuticalsLow-grade Upper Tract Urothelial Carcinoma

Start: 2025-06-12End: 2029-11-30Target: 20Updated: 2026-09-15

Phase 2

Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial

Not yet recruitingNCT07332351

University of WashingtonMuscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8

Start: 2026-12-01End: 2027-02-01Target: 33Updated: 2026-09-17

Phase 3

Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

RecruitingNCT06510374

Ferring PharmaceuticalsIntermediate Risk Non-Muscle Invasive Bladder Cancer

Start: 2024-10-01End: 2031-06-30Target: 454Updated: 2026-09-04

A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer

RecruitingNCT06545955

Ferring PharmaceuticalsNon-muscle Invasive Bladder Cancer With Carcinoma in Situ

Start: 2024-10-01End: 2030-12-31Target: 250Updated: 2026-08-06

A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)

RecruitingNCT06929286

Memorial Sloan Kettering Cancer CenterNon-Muscle Invasive Bladder Cancer

Start: 2025-04-11End: 2028-04-01Target: 125Updated: 2026-08-20

Phase 4

A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.

WithdrawnNCT06390111

Ferring PharmaceuticalsBladder Cancer, CIS, Ta/T1

Start: 2024-06-17End: 2026-07-31Updated: 2024-11-22

Related Papers

ABLE-32: A randomized, controlled, phase 3b clinical trial of nadofaragene firadenovec-vncg versus observation in patients with intermediate-risk non–muscle-invasive bladder cancer.

Journal of Clinical Oncology2025-05-283 citations

ABLE-22: Safety and efficacy evaluation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy—A randomized, open-label, phase 2 study.

Journal of Clinical Oncology2025-05-282 citations

ABLE-22: Safety and efficacy evaluation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy—A randomized, open-label, phase 2 study.

Journal of Clinical Oncology2025-02-101 citations

ABLE-32: A randomized, controlled, phase 3b clinical trial of nadofaragene firadenovec-vncg versus observation in patients with intermediate-risk non–muscle-invasive bladder cancer.

Journal of Clinical Oncology2025-02-10