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)

Recruiting now Phase 3 Last updated 19 May 2026

What this trial tests

Phase 3 trial testing ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) in Bladder Carcinoma in Situ (CIS) in 112 participants. Currently enrolling.

Timeline

29 December 2022

Primary endpoint
1 May 2028

1 December 2030

Quick facts

Lead sponsor	Fidia Farmaceutici s.p.a.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	112
Start date	29 December 2022
Primary completion	1 May 2028
Estimated completion	1 December 2030
Sites	47 locations across United States, France, Italy, Poland, Spain, United Kingdom

Drugs / interventions tested

• ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) — full drug profile →

Conditions studied

• Bladder Carcinoma in Situ (CIS) — all drugs for Bladder Carcinoma in Situ (CIS) →

Sponsor

Fidia Farmaceutici s.p.a. — full company profile →

Who can join

18 and older, any sex, with Bladder Carcinoma in Situ (CIS). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Centrally assessed Complete Response Rate (CRR) at any time.
  Time frame: CRR will be evaluated at any time from enrollment to 24 months after induction or re-induction start.
  CRR calculated as the proportion of patients achieving a CR at any time within 24 months after induction or re-induction start. CRR will be based on central assessment of response

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hyaluronic Acid: A Powerful Biomolecule with Wide-Ranging Applications-A Comprehensive Review.
   Iaconisi GN, Lunetti P, Gallo N, Cappello AR, et al · · 2023 · cited 122× · PMID 37373443 · DOI 10.3390/ijms241210296
2. A paclitaxel-hyaluronan conjugate (ONCOFID-P-B™) in patients with BCG-unresponsive carcinoma in situ of the bladder: a dynamic assessment of the tumor microenvironment.
   Tosi A, Parisatto B, Gaffo E, Bortoluzzi S, et al · · 2024 · cited 12× · PMID 38600583 · DOI 10.1186/s13046-024-03028-5
3. Hyaluronic Acid-Based Drug Delivery Systems for Cancer Therapy.
   Pashkina E, Bykova M, Berishvili M, Lazarev Y, et al · · 2025 · cited 11× · PMID 39851489 · DOI 10.3390/cells14020061
4. CD44 in Bladder Cancer.
   Duex J, Theodorescu D. · · 2024 · cited 7× · PMID 38539529 · DOI 10.3390/cancers16061195
5. Targeted Therapy in Non-Muscle Invasive Bladder Cancer-Clinical Updates.
   Passarelli R, Pfail J, Golombos D, Jang TL, et al · · 2024 · cited 1× · PMID 40964450 · DOI 10.33696/pharmacol.6.056
6. Clickable polyamidosaccharides: accessing bottlebrush inspired hyaluronic acid glycopolymers for CD44 targeting of breast cancer cells.
   Sockett KA, Loffredo MK, DeMoya CD, Garman ZG, et al · · 2026 · PMID 41705495 · DOI 10.1039/d5bm01613d
7. Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette-Guérin failure: a systematic review.
   Soma T, Takemura K, Toide M, Ito M, et al · · 2026 · PMID 41635525 · DOI 10.1136/bmjonc-2025-000753