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Bladder Carcinoma in Situ (CIS)Phase 3NCT05024773

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

A Phase 3 study testing ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) in people with Bladder Carcinoma in Situ (CIS), run by Fidia Farmaceutici s.p.a. at 47 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Carcinoma in Situ (CIS)
What is being tested?
ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
47 sitesin 6 countries
Study dates
29 Dec 2022to Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 full doses of six doses of an initial induction course plus at least two full doses of three doses of maintenance therapy.
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  • At least five full doses of six doses of an initial induction course plus at least two full doses 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,
  • ALT/AST ≤1. 5 x upper limit of normal (ULN),
  • alkaline phosphatase ≤ 5 x ULN,
  • total serum bilirubin ≤ 1.5 x ULN, for patients with Gilbert's ≤ 3 X ULN,
  • serum creatinine ≤ 2.2 mg/dL.
  • Women in non-reproductive years (defined as surgically sterile or one year postmenopausal). Women of childbearing potential (WOCBP) must have a negative serum pregnancy test upon entry into this study and agree to use highly effective contraceptive methods, i.e. methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include:
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
  • oral
  • intravaginal
  • transdermal
  • progestogen-only hormonal contraception associated with inhibition of ovulation:
  • oral
  • injectable
  • implantable
  • intrauterine device (IUD)
  • intrauterine hormone-releasing system (IUS)
  • bilateral tubal occlusion
  • vasectomised partner (*)
  • sexual abstinence (**)
  • Male patients with WOCBP partners must agree to use effective contraceptive methods, i.e.:
  • condom;
  • consider contraception for non-pregnant WOCBP partner.
  • Able and willing to comply with the scheduled visits, therapy plans, and laboratory tests required in this protocol.
  • () Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success.
  • () Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated to the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.

Who cannot join

  • Current or previous muscle-invasive disease (T2-T4) or metastatic urothelial carcinoma.
  • Patients with more than 12 months between inclusion and the last BCG instillation
  • Suspected hypersensitivity to paclitaxel or to any of the Oncofid-P-B constituents.
  • Previous or concomitant urothelial carcinoma 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.
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  • Symptomatic urinary tract infection or bacterial cystitis.
  • 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/mL, 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.
  • Subjects who have a mean QTc >450 msec for males and >470 msec for females at baseline and who need concomitant medications which may cause QT prolongation.
  • Applies to France Only:
  • Persons deprived of liberty by judical or administrative decision, adults subjects to a legal protection measure (under guardianship/curators), persons under protective measures and persons not affiliated with social security will be excluded from the study.

Trial locations and contacts

47 sites in 6 countries.

47 sites in 6 countries

Italy12 sites

  • Humanitas Gavazzeni

    Bergamo, 24125

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

    Bologna, 40138

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

    Castelfranco Veneto, 31033

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • ASL Lecce- Ospedale Vito Fazzi

    Lecce, 73100

  • Istituto Clinico Humanitas

    Milan, 20089

  • IRCSS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80131

  • IFO-Istituto Nazionale dei Tumori Regina Elena

    Roma, 00128

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

    Torino, 10126

  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

    Verona, 37126

Other trials in Italy

Spain12 sites

  • Vall d'Hebron Barcelona Hospital

    Barcelona, Barcelona, 08035

  • Hospital Universitari de Bellvitge

    Barcelona, Barcelona, 08907

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Universitario de Basurto

    Bilbao, 48013

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Fundación Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitario Fundacion Alcorcon

    Madrid, 28922

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Instituto Valenciano de Oncologia

    Valencia, Valencia, 46009

Other trials in Spain

France7 sites

  • CHU Bordeaux -Hopital Pellegrin

    Bordeaux, 33000

  • CHU de Clermont-Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, 63000

  • CHU de Lille - Hopital Claude Huriez

    Lille, 59000

  • Institute Paoli-Calmettes

    Marseille, 13009

  • AP-HP Hopital Bichat-Claude Bernard

    Paris, 75018

  • AP-HP Hopital Tenon

    Paris, 75020

  • Centre Hospitalier Universitaire Poitiers

    Poitiers, 90577

Other trials in France

United Kingdom7 sites

  • Darent Valley Hospital

    Dartford, Kent, DA2 8DA

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

  • St James's University Hospital

    Leeds, LS9 7TF

  • Barts Health NHS Trust

    London, EC1A7BE

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Royal Preston Hospital

    Preston, PR2 9HT

  • Royal Marsden Hospital - Surrey

    Sutton, SM2 5PT

Other trials in United Kingdom

United States6 sites

  • Johns Hopkins Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • TriState Urologic Services PSC Inc. dba The Urology Group

    Cincinnati, Ohio, 45212

  • Banner Health- MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70124

Other trials in United States

Poland3 sites

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

    Lublin, 20-090

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

    Przemyśl, Poland, 37-700

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

    Warsaw, Warszawa, 02-637

Other trials in Poland

About this study

Official title: 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)

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.

Being tested
ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05024773
Study groupRoleWhat they receive
ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)ExperimentalNot described
Receives: Drug: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Centrally assessed Complete Response Rate (CRR) at any time.

    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

    Measured: CRR will be evaluated at any time from enrollment to 24 months after induction or re-induction start.

Secondary outcomes (11)

  1. Centrally assessed CRR

    CRR calculated as the proportion of patients achieving a CR at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction start

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

  2. Duration of Response (DoR)

    DoR defined as the time from first documented evidence of CR to time of documented recurrence (CIS or Ta-T1), progression to MIBC, to extravesical disease, or death

    Measured: 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

  3. Duration of Response (DoR) rate

    DoR rate calculated as the proportion of patients who maintained a CR after 6, 9, 12, 15, 18, 21, 30, 36, 42 and 48 months after induction or re-induction start.

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

  4. Progression rate

    Progression rate calculated as the proportion of patients with muscle invasion or extravesical expansion of the disease at EOIT/EORIT, 15, 24 and 48 months after induction or re-induction start

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

  5. Time to progression

    Time to progression defined as time from treatment start to time of documented tumor progression to MIBC or extravesical disease.

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

  6. Rate of patients undergoing cystectomy

    Proportion of patients undergoing cystectomy for disease progression at EOIT/EORIT, 9, 15, 24 and 48 months after induction or re-induction start.

    Measured: Rate of patients undergoing cystectomy will be evaluated at EOIT/EROIT, 9, 15, 24, 24 and 48 months after induction or re-induction start.

  7. Time to cystectomy defined as time from start of treatment to the date of cystectomy

    Time to cystectomy is defined as the time (months) form start of treatment to the date of cystectomy, analyzed using the Kaplan-Meier method. The median time to cystectomy will be presented along with 95% CI.

    Measured: from start of treatment to date of cystectomy

  8. event-free survival (EFS)

    EFS defined as time from treatment start to the time of documented recurrence after CR, or progression or death due to any cause.

    Measured: Event-free survival (EFS) will be evaluated at any time during the study up to 48 months after treatment start

  9. Overall survival (OS)

    OS defined as time from treatment start to death due to any cause.

    Measured: overall survival (OS) will be evaluated at any time during the study up to 48 months after treatment start

  10. Incidence of Treatment-Emergent Adverse Events (Overall Safety)

    Overall safety and tolerability evaluated throughout the study on the basis of the incidence, nature, severity and causality of TEAEs, coded to preferred term and system organ class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA) and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5 and the incidence of serious adverse events (SAEs)

    Measured: Safety data will be evaluated up to study month 16

  11. Treatment time of retention (tolerability)

    The tolerability of ONCOFID-P-B expressed as the ability to retain intravesical instillation for the desired dwell time (optimal retention time is 120 minutes) and measured as time of retention.

    Measured: Tolerability will be evaluated up to study month 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start29 Dec 2022
  3. Primary completionMay 2028 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05024773
Sponsor's protocol ID
R39_21_01
Status last verified
Jun 2026
First submitted
20 Aug 2021
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) in people with Bladder Carcinoma in Situ (CIS), run by Fidia Farmaceutici s.p.a. at 47 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Italy, Spain, France, United Kingdom, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05024773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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