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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Ferring Pharmaceuticals
Study ID
NCT06545955
Phase
PHASE3
Status
Recruiting
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Conditions

  • Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nadofaragene Firadenovec — DRUG
    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.
  • Gemcitabine — DRUG
    Intravesical Gemcitabine chemotherapy, used in combination with Docetaxel.
  • Docetaxel — DRUG
    Intravesical Docetaxel chemotherapy, used in combination with Gemcitabine.
  • Pembrolizumab — DRUG
    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.

Study Details

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).

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2025
Primary completion
Jun 30, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nadofaragene firadenovec
    Nadofaragene firadenovec (intravesical)
  • Experimental: Nadofaragene firadenovec + gemcitabine & docetaxel
    Nadofaragene firadenovec (intravesical), and sequential gemcitabine and docetaxel (intravesical)
  • Experimental: Nadofaragene firadenovec + Pembrolizumab
    Nadofaragene firadenovec (intravesical), and pembrolizumab (IV infusion). This arm will be closed and patients will no longer be randomised to this arm. This modification will convert ABLE-22 into a two-arm study with 1:1 randomisation between nadofaragene alone and nadofaragene + gemcitabine/docetaxel, to now N=100 in each of the 2 remaining arms. Participants already enrolled in this arm will not be impacted.

Primary Outcome Measure

Complete response [ Time Frame: up to 6 months ]

Central Contacts

Locations (38)

FacilityCityStateZIPSite coordinators
Center for NeurosciencesTucsonArizona85718-
Arkansas Urology, North Little RockLittle RockArkansas72211-
American Institute of ResearchLos AngelesCalifornia90017-
USC Kenneth Norris Jr Cancer HospitalLos AngelesCalifornia90080-
University of California, IrvineOrangeCalifornia92868-
Genesis Research, LLC - San DiegoSan DiegoCalifornia92123-
Advent HealthDenverColorado80210-
Colorado Urology - St. Anthony Hospital CampusLakewoodColorado80228-
Yale School of MedicineNew HavenConnecticut06519-
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007-
Sarasota Memorial Healthcare SystemSarasotaFlorida34239-
Emory UniversityAtlantaGeorgia30322-
Georgia UrologyAtlantaGeorgia30328-
Boise VA Medical CenterBoiseIdaho83702-
NextStage Clinical ResearchLisleIllinois60532-
Indiana UniversityIndianapolisIndiana46202-
Wichita Urology GroupWichitaKansas67226-
Anne Arundel Urology, PAAnnapolisMaryland21401-
Chesapeake Urology Research AssociatesHanoverMaryland21076-
Atlantic HealthMorristownNew Jersey07960-
Roswell Park Cancer InstituteBuffaloNew York14263-
Great Lakes Physician PC d/b/a Western new York Urology AssociatesCheektowagaNew York14225-
Northwell Health -The Arthur Smith Institute for UrologyLake SuccessNew York11042-
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical CenterNew YorkNew York10010-
James J. Peters VA Medical CenterThe BronxNew York10468-
University of CincinnatiCincinnatiOhio45267-
MidLantic UrologyBala-CynwydPennsylvania19004-
Keystone Urology SpecialistsLancasterPennsylvania17601-
University of Pennsylvania - Perelman Center for Advanced Medicine - Penn UrologyPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center - Shadyside Medical BuildingPittsburghPennsylvania15232-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
The Conrad Pearson Clinic - Wolf River Office (Urology Center of the South)GermantownTennessee38138-
Urology Associates, P.C.NashvilleTennessee37209-
Urology AustinAustinTexas78759-
University of Texas Southwestern Medical Center - Urology ClinicDallasTexas75390-
Urology Clinics of North Texas PLLC (Dallas)DallasTexas75231-
Houston Methodist Hospital (Houston)HoustonTexas77030-
Virginia Mason Medical CenterSeattleWashington98101-

Find similar trials in Tucson, AZ

By research site
Center for Neurosciences· Tucson, AZArkansas Urology, North Little Rock· Little Rock, ARAmerican Institute of Research· Los Angeles, CAUSC Kenneth Norris Jr Cancer Hospital· Los Angeles, CAUniversity of California, Irvine· Orange, CAGenesis Research, LLC - San Diego· San Diego, CA

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