🏛️ Verified NIH Record • Updated 2026-06-19

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) (NCT05024773)

A Phase III, Single-arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (Paclitaxel-hyaluronic Acid Conjugate) Administered Intravesically to Patients With BCG-unresponsive Carcinoma in Situ of the Bladder With or Without Ta-T1 Papillary Disease (Orion-BC)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Fidia Farmaceutici s.p.a.

🩺 Plain-English Summary (8th-Grade Level)

This is a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy. After providing written informed consent (in presence of an Independent Witness, if applicable), patients will receive an induction therapy consisting of 12 weekly intravesical instillations of ONCOFID-P-B (induction phase). Patients with residual CIS at the end of induction treatment are eligible to enter a re-induction course of therapy (reinduction phase). Patients with stable disease by Investigator assessment defined as neither increased or decreased in extent or severity compared to baseline, are not eligible for re-induction therapy. Patients who achieve a complete resonde (CR) at the end of the induction or re-induction phase enter in the maintenance phase and receive monthly intravesical instillations of ONCOFID-P-B for an additional 12 monsthe or untile recurrence of CIS/HG Ta-T1 or progression to MIBC or extravesical disease. Patients who do not achieve a CR at the end of induction or re-induction phase, will discontinue investigational treatement and are followed up until month 48 from induction or re-induction start, or until a new antitumor therapy is initiated, wichever occurs first. Tumor response is evaluated by cystoscopy, cytology and biopsy at the end of the induction and re-induction phases and at Safety Follow Up Visit (SFUV). During the maintenance/follow-up period, tumorresponse is evaluated by cystoscopy and cytology every 3 months for up to 24 months from induction or re-induction start, and then every 6 months for an additional 2 years (long-term follow-up). Tumor biopsies are performed in case of of positive cystoscopy and/or cytology. Random biopsies are to be performed at 6, 12 and 18 months after the end of the induction or re-induction phase in responding patients (i.e. at 9, 15 and 21 months after induction or re-induction start.

Who can join: Review the eligibility criteria below.

Location: Banner Health- MD Anderson Cancer Center — Gilbert, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (47 Sites)

Showing the first 25 of 47 sites.

  • Banner Health- MD Anderson Cancer Center — Gilbert, Arizona
  • Ochsner Clinic Foundation — New Orleans, Louisiana
  • Johns Hopkins Kimmel Cancer Center — Baltimore, Maryland
  • University of Minnesota — Minneapolis, Minnesota
  • TriState Urologic Services PSC Inc. dba The Urology Group — Cincinnati, Ohio
  • Medical University of South Carolina (MUSC) — Charleston, South Carolina
  • CHU Bordeaux -Hopital Pellegrin — Bordeaux,
  • CHU de Clermont-Ferrand - Hopital Gabriel Montpied — Clermont-Ferrand,
  • CHU de Lille - Hopital Claude Huriez — Lille,
  • Institute Paoli-Calmettes — Marseille,
  • AP-HP Hopital Bichat-Claude Bernard — Paris,
  • AP-HP Hopital Tenon — Paris,
  • Centre Hospitalier Universitaire Poitiers — Poitiers,
  • Humanitas Gavazzeni — Bergamo,
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola — Bologna,
  • Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San Giacomo — Castelfranco Veneto,
  • Azienda Ospedaliero-Universitaria Careggi — Florence,
  • ASL Lecce- Ospedale Vito Fazzi — Lecce,
  • Istituto Clinico Humanitas — Milan,
  • IRCSS Ospedale San Raffaele — Milan,
  • Fondazione IRCCS Istituto Nazionale dei Tumori — Milan,
  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale — Naples,
  • IFO-Istituto Nazionale dei Tumori Regina Elena — Roma,
  • AOU Città della Salute e della Scienza di Torino-Ospedale le Molinette — Torino,
  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento — Verona,

📞 Contact the Study Coordinator

Phone: (877) 632-6789

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Bladder Carcinoma in Situ (CIS) clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗