AzTrials
AzTrials

Non-Muscle- Invasive Bladder CancerPhase 3PATAPSCONCT05943106

BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants

A Phase 3 study testing Durvalumab and BCG in people with Non-Muscle- Invasive Bladder Cancer, run by AstraZeneca at 19 sites in United States.

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

The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have received no prior… Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Non-Muscle- Invasive Bladder Cancer
What is being tested?
Durvalumab and BCG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
19 sitesUnited States
Study dates
11 Aug 2023to 31 Mar 2027
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 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BCG-naïve (defined as participants not having received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry).
  • Local histological confirmation (based on cytology and/or pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa.
  • Complete resection of all Ta/T1 papillary disease prior to enrollment, with the transurethral resection of bladder tumor (TURBT) removing high-risk NMIBC (non-muscle invasive bladder cancer) performed not more than 4 months before enrollment in the study.
  • No prior radiotherapy for bladder cancer.
  • A life expectancy of at least 12 weeks (90 days).
  • Adequate organ and marrow function
Show all 10Show fewer
  • World Health Organization/Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
  • No prior exposure to immune-mediated therapy of cancer
  • A candidate for BCG treatment.
  • Local histological confirmation (based on cytology and/or pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high-risk tumor is defined as one of the following: T1 tumor; High-grade/G3 tumor; CIS.

Who cannot join

  • Evidence of muscle-invasive, locally advanced, metastatic, and/or extra-vesical bladder cancer (ie, T2, T3, T4, and / or Stage IV).
  • Predominantly variant histology such as micropapillary, plasmacytoid, nested, sarcomatoid, microcystic, squamous and adeno variants of UC representing > 50% of tumor tissue or other than urothelial tumors as assessed by pathology.
  • Evidence of lymphovascular invasion of bladder tumor, except if treatment with BCG is deemed to be the only clinically viable treatment.
  • Immediate cystectomy is indicated.
  • Known or documented absolute and/or relative contraindication of adjuvant intravesical BCG treatment.
  • Concurrent extravesical, non-muscle-invasive transitional cell carcinoma of the urothelium.
Show all 16Show fewer
  • History of allogenic organ transplantation. Participants with any history of allogenic stem cell transplantation are also excluded.
  • Active or prior documented autoimmune or inflammatory disorders.
  • Participants with hypothyroidism stable on hormone replacement.
  • History of active primary immunodeficiency.
  • Active infection including hepatitis B (known positive HBV/HBsAg result), HCV, or HIV 1/2 (positive HIV) antibodies.
  • Current or prior use of immunosuppressive medication within 14 days before the first durvalumab dose.
  • Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ highly effective birth control.
  • Any concurrent chemotherapy, study intervention, biologic or hormonal therapy for cancer treatment; uncontrolled intercurrent illness;
  • History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥ 2 years; Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated CIS without evidence of disease; Prostate cancer of stage ≤ T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention.
  • Previous or concurrent treatment with potent systemic immunostimulatory agents

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Research Site

    Austin, Texas, 78759

  • Research Site

    Bala-Cynwyd, Pennsylvania, 19004-1017

  • Research Site

    Baltimore, Maryland, 21203

  • Research Site

    Cincinnati, Ohio, 45212

  • Research Site

    Greenwood, Indiana, 46143

  • Research Site

    Hanover, Maryland, 21076

  • Research Site

    Hialeah, Florida, 33016

  • Research Site

    Jacksonville, Florida, 32209

  • Research Site

    Lakewood, Colorado, 80228

  • Research Site

    Little Rock, Arkansas, 72211

  • Research Site

    Myrtle Beach, South Carolina, 29572

  • Research Site

    Nashville, Tennessee, 37209

  • Research Site

    Phoenix, Arizona, 85054

  • Research Site

    Royal Oak, Michigan, 48073

  • Research Site

    San Diego, California, 92123

  • Research Site

    Spokane, Washington, 99202

  • Research Site

    Syracuse, New York, 13210

  • Research Site

    Troy, Michigan, 48084

  • Research Site

    Wichita, Kansas, 67226

Other trials in United States

About this study

Official title: A Phase IIIb Open-Label, Single-Arm, Multi-Center, US Study of Bacillus Calmette-Guerin (BCG) Administered in Combination With Durvalumab in Adult BCG-naïve, High-risk Non-Muscle- Invasive Bladder Cancer Participants (PATAPSCO)

The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have received no prior systemic therapy for NMIBC, and who are BCG-naïve.

Read the detailed description

This is an open-label, single-arm, multi-center, Phase IIIb US study exploring the combination of durvalumab and BCG (induction and maintenance) in participants with high-risk NMIBC.

Each participant will have screening activities up to 4 weeks before initiation of study intervention, receive study intervention for up to 24 months, followed by 3 months safety follow-up. Participants will continue to be followed up for survival until 2 years from the date of treatment initiation of the last participant enrolled in this study (approximately 42 months after first participant enrolled).

Being tested
Durvalumab, BCG
Keywords
Bacillus Calmette-Guerin (BCG), BCG-naïve, immunotherapeutics, human mAb, Durvalumab, non-muscle-invasive bladder cancer (NMIBC)
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

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

  • DurvalumabBiological

    Participants will receive Durvalumab via intravenous infusion from Week 1 for 13 cycles every 4 weeks (q4w) for maximum 12 months.

  • BCGBiological

    Participants will receive BCG via intravesical as induction weekly for 6 weeks starting at Week 1, Day 1 and subsequently for maintenance for 3 weekly doses up to 3, 6, 12, 18, and 24 months, at the physician's discretion as Standard of care.

Study groups in NCT05943106
Study groupRoleWhat they receive
Durvalumab + BCGExperimentalParticipants will receive Durvalumab for 13 cycles every 4 weeks (q4w) for a maximum 12 months. All participants will receive BCG (supplied by the site) intravesically, as induction weekly for 6 weeks. Patients will subsequently receive BCG for maintenance for 3 weekly doses at 3,6,12,18, and up to 24 months, at the physician's discretion.
Receives: Biological: Durvalumab; Biological: BCG

What is being measured

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

  1. Incidence of Grade 3 or 4 Possibly related adverse events (PRAEs)

    A PRAE is defined as an AE that has been assessed by the Investigator to be possibly related to study treatment. A PRAE will be included if it has onset or worsens (by Investigator report of an increase in CTCAE (common terminology criteria for adverse events) grade relative to pre-treatment) within 6 months of initiation of study intervention and it has CTCAE Grade 3 or 4 recorded within this timeframe.

    Measured: From the date of the first dose of study treatment (Day 1) until 6 months after the initiation of study treatment

Secondary outcomes (7)

  1. Number of participants with adverse events (AEs)

    To further assess the safety and tolerability of durvalumab + BCG (induction and maintenance) combination therapy in high risk NMIBC participants. Number of participants with adverse events (AEs), including PRAEs, adverse events of special interest (AESIs), immune-mediated AEs, serious adverse events (SAEs), AEs resulting in treatment interruption and discontinuation will be assessed.

    Measured: From screening (Day -28 to -1) until 90 days following discontinuation of the last dose of study treatment (approximately 28 months)

  2. Percentage of patient-reported treatment tolerability symptoms assessed using specific PRO-CTCAE (Patient-Reported Outcomes- Common Terminology Criteria for Adverse Events)

    To assess patient-reported treatment tolerability in high-risk NMIBC participants treated with durvalumab + BCG (induction and maintenance) combination therapy by descriptive summary of PRO-CTCAE.

    Percentage of all dosed participants reporting each response category of each of the 19 relevant disease symptom items as measured by PRO-CTCAE. The PRO-CTCAE system, is an item bank of symptoms experienced by participants while undergoing treatment of their cancer.

    Measured: Up to 24 months

  3. Complete response rate (CRR)

    Complete response rate (CRR) is defined as the percentage of participants having carcinoma in situ (CIS) prior to study entry or at baseline cystoscopy who do not have CIS at 6 months.

    Measured: At 6 months

  4. Disease-free survival (DFS)

    Disease-free survival (DFS) is defined as the time from the date of first dose of study intervention until the date of first recurrence of high-risk disease or death (by any cause in the absence of recurrence) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to recurrence.

    Measured: At 12 months and 24 months

  5. Overall survival (OS)

    Overall survival (OS) is defined as the time from the date of the first dose of study intervention to the date of death from any cause.

    The analysis will include all dosed participants. All deaths will be included regardless of whether the participant withdraws from therapy or receives another anticancer therapy.

    Measured: At 24 months

  6. Best overall response for health-related quality of life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30)

    Best overall response is defined as the best response the participant achieved, based on evaluable data collected during the study period to assess disease and treatment related symptoms and HRQoL. The domains/scales of the EORTC QLQ-C30 prioritized include global HRQoL, physical functioning and fatigue. Final scores range from 0 to 100, where higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.

    Measured: Up to 24 months

  7. Best overall response for HRQoL as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Non-Muscle-Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24)

    Best overall response is defined as the best response the participant achieved, based on evaluable data collected during the study period. The domains/scales of the EORTC QLQ-NMIBC24 prioritized include urinary symptoms, intravesical treatment concerns, future perspectives and sexual functioning. Final scores range from 0 to 100, higher scores on the functioning scales (sexual functioning, sexual enjoyment) indicate better health status/function, whereas higher scores on symptom scales and individual symptom items represent greater symptom severity.

    Measured: Up to 24 months

Timeline

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

  1. First posted13 Jul 2023
  2. Study start11 Aug 2023
  3. Primary completion16 Jun 2025
  4. Study completion31 Mar 2027 (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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05943106
Sponsor's protocol ID
D419JC00002
Acronym
PATAPSCO
Status last verified
Aug 2026
First submitted
5 Jul 2023
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab and BCG in people with Non-Muscle- Invasive Bladder Cancer, run by AstraZeneca at 19 sites in United States.

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 10 inclusion and 16 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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?

Incidence of Grade 3 or 4 Possibly related adverse events (PRAEs) (time frame: From the date of the first dose of study treatment (Day 1) until 6 months after the initiation of study treatment). 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 NCT05943106.

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 13 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in