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

NCT05024773 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: R39_21_01
• Study Type: interventional
• Target: 112
• Locations: 6 countries
• Sites: 47

Brief Summary

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.

Conditions

Bladder Carcinoma in Situ (CIS)

Outcome Measures

Primary Outcomes (1)

• Centrally assessed Complete Response Rate (CRR) at any time

  CRR calculated as the proportion of patients achieving a CR at any time. CRR will be based on central assessment of response

  CRR will be evaluated at any time

Secondary Outcomes (11)

• Centrally assessed CRR

  CRR will be evaluated at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction

• Duration of Response (DoR)

  DoR will be evaluated at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-inductiononths after treatment start

• Duration of Response (DoR) rate

  DoR rates will be evaluated at 6, 9, 12, 15, 18, 21, 30, 36, 42 and 48 after induction or re-induction start

• Progression rate

  Progression rate will be evaluated at EOIT/EROIT, 15, 24 and 48 months after induction or re-inductionstart

• Time to progression

  Time to progression will be evaluated at 15, 24 and 48 months after induction or re-induction start

Study Arms (1)

ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)

EXPERIMENTAL

Drug: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)

Interventions

ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) DRUG

Schedule: once a week for 12 consecutive weeks (induction phase). Patients who achieve a complete response at the end of the induction phase will enter the maintenance phase, during which ONCOFID-P-B is administered once a month for 12 months until recurrence or progression of the disease.

ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to freely provide written informed consent (in presence of an Independent Witness if applicable) prior to performing study procedures.
• Age 18 years or older, male or female.
• Persistent or recurrent histologically confirmed CIS of the bladder with or without concomitant recurrent HG Ta-T1 and with no evidence of metastases demonstrated by abdominal CT scan or MRI.
• "BCG unresponsive" patients who refuse radical cystectomy or are not clinically suitable for cystectomy. BCG unresponsive disease is defined as persistent or recurrent CIS alone or with recurrent HG Ta-T1 within 12 months of completion of adequate BCG therapy.
• Adequate BCG therapy is defined as at least one of the following:
• At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy.
• At least five of six doses of an initial induction course plus at least two of six doses of a second induction course.
• Complete resection of Ta-T1 papillary lesions before entering the trial in patients with concomitant CIS and papillary tumors (residual CIS acceptable, obvious areas of CIS should also be fulgurated).
• In patients with T1 papillary lesions undergoing resection of the base of the lesion, the biopsy should contain muscle fibers.
• In patients undergoing transurethal resection of their bladder tumors, absence of locally advanced disease should be confirmed by pelvic examination under anesthesia.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Adequate organ function:
• absolute neutrophil count ≥ 1,500/mm3,
• platelets ≥ 100,000/mm3,
• hemoglobin ≥ 8.5 g/dL,

You may not qualify if:

• Current or previous muscle-invasive disease (T2-T4) or metastatic urothelial carcinoma.
• Suspected hypersensitivity to paclitaxel or to any of the Oncofid-P-B constituents.
• Previous or concomitant cancer of the upper urinary tract or the prostatic urethra. Freedom from upper tract disease must be demonstrated by intravenous pyelogram, retrograde pyelogram, CT scan or MRI.
• Current or prior systemic therapy for bladder cancer.
• Intravesical therapy within 4 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g. mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure between 14 to 60 days prior to beginning study treatment.
• Symptomatic urinary tract infection or bacterial cystitis. Once successfully treated (negative urine culture), patients may enter the study.
• Major surgery, other than diagnostic, within 4 weeks prior to treatment.
• Patients who have previous or concurrent malignancies that require treatment and are not clinically stable; examples of permitted concurrent recent second malignancies are: adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix or prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) \<10 ng/dL, Gleason score 6 or less and cT1.
• Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders).
• Presence of significant urologic disease interfering with intravesical therapy.
• Current enrollment or participation in another therapeutic clinical trial within 6 months preceding screening. Patients previously included in a BCG-only study arm might be enrolled following discussion with the medical monitor and/or sponsor if the definition of adequate BCG therapy is met.
• Known substance and/or alcohol abuse.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry in this study or could compromise protocol objectives.
• Pregnancy, lactating women or women of childbearing potential (WOCBP) unwilling to use adequate birth control measures for the duration of the study and until 3 months after the end of treatment.
• Male patients with WOCBP partners unwilling to use contraceptive methods for the duration of the study and until 6 months after the end of treatment.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (47)

Banner Health- MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70124, United States

RECRUITING

Johns Hopkins Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

TriState Urologic Services PSC Inc. dba The Urology Group

Cincinnati, Ohio, 45212, United States

RECRUITING

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

RECRUITING

CHU Bordeaux -Hopital Pellegrin

Bordeaux, 33000, France

RECRUITING

CHU de Clermont-Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

RECRUITING

CHU de Lille - Hopital Claude Huriez

Lille, 59000, France

RECRUITING

Institute Paoli-Calmettes

Marseille, 13009, France

RECRUITING

AP-HP Hopital Bichat-Claude Bernard

Paris, 75018, France

RECRUITING

AP-HP Hopital Tenon

Paris, 75020, France

TERMINATED

Centre Hospitalier Universitaire Poitiers

Poitiers, 90577, France

RECRUITING

Humanitas Gavazzeni

Bergamo, 24125, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San Giacomo

Castelfranco Veneto, 31033, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

RECRUITING

ASL Lecce- Ospedale Vito Fazzi

Lecce, 73100, Italy

RECRUITING

Istituto Clinico Humanitas

Milan, 20089, Italy

RECRUITING

IRCSS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, 80131, Italy

RECRUITING

IFO-Istituto Nazionale dei Tumori Regina Elena

Roma, 00128, Italy

RECRUITING

AOU Città della Salute e della Scienza di Torino-Ospedale le Molinette

Torino, 10126, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

Verona, 37126, Italy

RECRUITING

Wojewodzki Szpital im Sw. Ojca Pio w Przemyslu, Oddzial Urologiczny z Pododdzialem Urologii Onkologicznej

Przemyśl, Poland, 37-700, Poland

RECRUITING

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

Warsaw, Warszawa, 02-637, Poland

TERMINATED

Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Oddzial Urologiczny

Lublin, 20-090, Poland

TERMINATED

Vall d'Hebron Barcelona Hospital

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Universitari de Bellvitge

Barcelona, Barcelona, 08907, Spain

RECRUITING

Instituto Valenciano de Oncologia

Valencia, Valencia, 46009, Spain

RECRUITING

Hospital Clinic Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario de Basurto

Bilbao, 48013, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

Hospital Fundación Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Fundacion Alcorcon

Madrid, 28922, Spain

TERMINATED

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Darent Valley Hospital

Dartford, Kent, DA2 8DA, United Kingdom

RECRUITING

Huddersfield Royal Infirmary

Huddersfield, HD3 3EA, United Kingdom

RECRUITING

St James's University Hospital

Leeds, LS9 7TF, United Kingdom

RECRUITING

Barts Health NHS Trust

London, EC1A7BE, United Kingdom

RECRUITING

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

RECRUITING

Royal Marsden Hospital - Surrey

Sutton, SM2 5PT, United Kingdom

RECRUITING

Central Study Contacts

Nicola Giordan

CONTACT

+390498232512; ngiordan@fidiapharma.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 27, 2021
• Study Start: December 29, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

PL (3); GB (7); ES (12); IT (12); US (6); FR (7)