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

PHASE3RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

June 30, 2028

Study Completion Date

December 31, 2030

Conditions
Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Interventions
DRUG

Nadofaragene Firadenovec

vector-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.

DRUG

Gemcitabine

Intravesical Gemcitabine chemotherapy, used in combination with Docetaxel.

DRUG

Docetaxel

Intravesical Docetaxel chemotherapy, used in combination with Gemcitabine.

DRUG

Pembrolizumab

Pembrolizumab 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.

Trial Locations (21)

10468

RECRUITING

James J. Peters VA Medical Center, The Bronx

11042

RECRUITING

Northwell Health -The Arthur Smith Institute for Urology, Lake Success

12603

RECRUITING

Premier Medical Group of the Hudson Valley, Poughkeepsie

14225

RECRUITING

Great Lakes Physician PC d/b/a Western new York Urology Associates, Cheektowaga

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

19004

RECRUITING

MidLantic Urology, Bala-Cynwyd

29572

RECRUITING

Carolina Urologic Research Center, Myrtle Beach

30322

RECRUITING

Emory University, Atlanta

30328

RECRUITING

Georgia Urology, Atlanta

45267

RECRUITING

University of Cincinnati, Cincinnati

46202

RECRUITING

Indiana University, Indianapolis

48084

RECRUITING

Ferring Investigational Site, Troy

67226

RECRUITING

Wichita Urology Group, Wichita

77030

RECRUITING

Houston Methodist Hospital (Houston), Houston

83702

RECRUITING

Boise VA Medical Center, Boise

90017

RECRUITING

American Institute of Research, Los Angeles

90080

RECRUITING

USC Kenneth Norris Jr Cancer Hospital, Los Angeles

92123

RECRUITING

Genesis Research, LLC - San Diego, San Diego

92868

RECRUITING

University of California, Irvine, Orange

06519

RECRUITING

Yale School of Medicine, New Haven

07960

RECRUITING

Atlantic Health, Morristown

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY

NCT06545955 - 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 | Biotech Hunter | Biotech Hunter