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Bladder CancerPhase 2NCT03768570

Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer

A Phase 2 study testing Durvalumab in people with Bladder Cancer, run by Canadian Cancer Trials Group at 31 sites in 3 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

The purpose of this study is to find out what effects durvalumab has on bladder cancer, combined with treatment after completion of surgery, chemotherapy and radiotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
31 sitesin 3 countries
Study dates
25 Oct 2019to 31 Dec 2026
Phase
Phase 2
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

  • Histologic diagnosis of urothelial carcinoma of the bladder. Patients with mixed histology (including small cell) and urothelial carcinoma are eligible. Patients with pure small cell carcinoma will be excluded.
  • Stage T2-T4a N0M0 at time of diagnosis based on trans-urethral resection of bladder tumour, imaging, and/or bimanual examination under anesthesia.
  • CT scan of the chest/abdomen/pelvis within 8 weeks from enrollment, showing no evidence of metastatic disease.
  • Patients must be ≥ 18 years of age.
  • Patients must have a life expectancy greater than 6 months.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and a body weight of > 30kg.
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  • Patients must have adequate hematologic reserve: Platelet count ≥ 75 x 10^9/L, Absolute neutrophils ≥ 1.0 x 10^9/L. Anemia will be corrected to minimum hemoglobin of 90 g/L with red cell transfusions, if necessary.
  • Patients must have an estimated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 ml/min.
  • Patients must have adequate liver function with a bilirubin ≤ 1.5 ULN (if confirmed Gilbert's, eligible providing bilirubin ≤ 3 x UNL) and AST/ALT (SGOT/SGPT) < 2.5 x the upper normal limit.
  • All patients must have a tumour block from their primary tumour available and consent to release the block/cores/cut slides for correlative analyses ( and the centre/pathologist must have agreed to the submission of the specimen(s).
  • Patients have completed prior trimodality therapy (TMT) consisting of surgery, chemotherapy and radiation therapy treatment prior to enrollment. Patient should start treatment within 42 days after completion of TMT.
  • Patients must have undergone a transurethral resection prior to study enrollment.
  • Patient may have completed up to 4 cycles of cisplatin-based neo-adjuvant chemotherapy. Adjuvant chemotherapy is not permitted. Patients will have received cisplatin, given intravenously during the radiation therapy. OR Patients may have received fluorouracil and mitomycin given intravenously once weekly or gemcitabine as an alternative to cisplatin during radiotherapy.
  • The following are radiotherapy guidelines for patients treated on study. Patients will be treated to radical treatment doses using IMRT, VMAT or 4 field conformal techniques. Planning will be based on CT planning. IGRT is recommended during the radiotherapy treatment. Recognizing differences in usual radiotherapy doses used in the various participating countries and centres the following would be acceptable doses in this study. The bladder CTV will include the whole empty bladder and any extravesical extension. PTV expansion will be a minimum of 0.75 cm right, left and inferiorly, 1.5 cm Anteriorly and superiorly and 1 cm posteriorly. These minimum expansions are with Cone beam verification. For patients undergoing RT without image-guided verification 1.5 cm expansion in all directions is recommended. Acceptable doses for this study include:
  • Bladder only: 64-66 Gy in 32-33 fractions over 6.5 weeks; 50-55 Gy in 20 fractions over 4 weeks
  • Pelvis and bladder: 45-46 Gy to pelvic nodes + 17-20 Gy bladder boost in 33-35 fractions over 6.5-7 wks [Note: minimal nodal dose (if used) is 44 Gy in 32f or 40 Gy in 20f]
  • Patients receiving concurrent bladder boost: pelvis dose 40 Gy and bladder dose 50 Gy given in 20 fractions over 4 weeks. Adaptive radiotherapy techniques would be acceptable.
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English, French or Spanish.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
  • Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits placed on patients being considered for this trial.
  • In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment.
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during and for 3 months following treatment.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Who cannot join

  • Pre-existing medical conditions precluding treatment.
  • Pregnancy or lactating mothers.
  • Received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, including durvalumab anti-programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumour Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (e.g. colitis or Crohn's disease: not due to radiation reaction), diverticulitis with the exception of diverticulosis, celiac disease (controlled by diet alone) or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
  • Patients with alopecia;
  • Patients with Grave's disease, vitiligo or psoriasis not requiring systemic treatment (within the last 2 years);
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  • Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement;
  • Any chronic skin condition that does not require systemic therapy.
  • Patients with active or uncontrolled intercurrent illness including, but not limited to:
  • cardiac dysfunction (symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia);
  • active peptic ulcer disease or gastritis;
  • active bleeding diatheses;
  • psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent;
  • known history of previous clinical diagnosis of tuberculosis;
  • known active human immunodeficiency virus infection (positive HIV 1/2 antibodies). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible;
  • known active hepatitis B infection (positive HBV surface antigen (HBsAg). Patients with a past or resolved HBV infection (defined as presence of hepatitis B core antibody (anti-HBc) and absence of HBsAg) are eligible;
  • known active hepatitis C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy or grade ≥ 3 infusion reaction.
  • Current or prior use of immunosuppressive medication within 28 days of study entry, with the exceptions of intranasal and inhaled corticosteroids or systemic chronic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Corticosteroids used on study for anti-emetic purpose are allowed. Corticosteroids as premedication for hypersensitivity reactions (e.g. computed tomography [CT] scan premedication) are allowed.
  • Peripheral neuropathy ≥ grade 2 (CTCAE v5.0).
  • History of allergic or hypersensitivity reactions to any study drug or their excipients.
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec in screening ECG measured using standard institutional method or history of familial long QT syndrome.
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline CT scan.
  • Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
  • Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
  • Live attenuated vaccination administered within 30 days prior to randomization.
  • Any prior carboplatin based therapy.

Trial locations and contacts

31 sites in 3 countries.

31 sites in 3 countries

Canada15 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Thunder Bay Regional Health Sciences Centre/

    Thunder Bay, Ontario, P7B 6V4

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Spain8 sites

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

United Kingdom8 sites

  • Royal Cornwall Hospitals NHS Trust

    Cornwall, England, TR1 3LQ

  • Royal Devon and Exeter Hospital

    Exeter, Devon, EX2 5DW

  • Royal Preston Hospital

    Lancashire, England, PR2 9HT

  • Charing Cross Hospital

    London, England, VV6 8RF

  • The Christie NHS Foundation Trust

    Manchester, England

  • Nottingham University Hospitals City Hospital Campus

    Nottingham, NG5 1PB

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD

  • The Royal Marsden NHS Foundation Trust - Sutton

    Surrey, England

Other trials in United Kingdom

About this study

Official title: A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer

The purpose of this study is to find out what effects durvalumab has on bladder cancer, combined with treatment after completion of surgery, chemotherapy and radiotherapy.

Read the detailed description

This study is looking at whether a type of immunotherapy drug called durvalumab can be safely administered after initial treatment received by a patient. Durvalumab has been tested in many different types of cancers. Durvalumab works by allowing the immune system to detect cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. It is unclear if the addition of durvalumab is beneficial in patients with bladder cancer who have completed surgery, radiotherapy and chemotherapy.

Conditions
Bladder Cancer
Being tested
Durvalumab
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • DurvalumabDrug

    1500 mg IV on day 1 of 4 week cycle every 4 weeks for 12 months

Study groups in NCT03768570
Study groupRoleWhat they receive
SurveillanceNo interventionNot described
DurvalumabActive comparatorNot described
Receives: Drug: Durvalumab

What is being measured

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

  1. Disease-free survival

    defined as the time from the randomization to the time of the first event that is either recurrent (local or distant) bladder cancer, a new primary bladder cancer or death from any cause

    Measured: 5 years

Secondary outcomes (9)

  1. Non-muscle invasive bladder cancer recurrence rate

    Measured: 5 years

  2. Loco-regional control rate between study arms at the 12 week visit

    defined as proportion of patients with a confirmed locoregional complete response at 3 months post randomization

    Measured: 5 years

  3. Patterns of disease recurrence between study arms

    The two treatment arms will be compared using the log-rank test stratified by ECOG Performance Status (0, 1 vs. 2+), Neoadjuvant chemotherapy (Yes/No), whole bladder versus partial bladder versus bladder plus regional lymph nodes RT field, and disease stage (T2 vs T3/4). A table will be presented summarizing the patterns of disease recurrence by treatment arms

    Measured: 5 years

  4. Compare overall and bladder intact disease-free survival between study arms

    Measured: 5 years

  5. Metastasis-free survival between study arms

    Measured: 5 years

  6. Number and severity of adverse events between study arms

    Measured: 5 years

  7. Quality of Life between treatment arms using Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) questionnaire

    It consists of 39 questions, of which 12 are specific to bladder cancer. The questionnaire consists of 5 subscales: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a final subscale focusing specifically on bladder cancer.

    Measured: 5 years

  8. Cost-effectiveness between study arms

    Estimate an incremental cost-effectiveness ratio reported as a difference in cost per Disease free survival-year gained of durvalumab vs. surveillance. analyses will focus on the incremental cost-effectiveness of durvalumab from a government payer perspective, over a disease-free survival time horizon by prospectively collecting economic and resource utilization information during the clinical trial.

    Measured: 5 years

  9. Cost-utility between study arms

    A partitioned-survival model (Markov model) will be developed using data obtained from the trial. Different parametric models will be evaluated to fit data from the trial in order to evaluate the incremental cost-utility over a 3-, 5- and 10-y horizon.

    Measured: 5 years

Timeline

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

  1. First posted7 Dec 2018
  2. Study start25 Oct 2019
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03768570
Sponsor's protocol ID
BL13
Other IDs
2019-001310-42, 2019
Status last verified
Jun 2026
First submitted
5 Dec 2018
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab in people with Bladder Cancer, run by Canadian Cancer Trials Group at 31 sites in 3 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 23 inclusion and 27 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 18 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 31 sites in Canada, Spain, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Disease-free survival (time frame: 5 years). 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 NCT03768570.

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 18 Jun 2026.

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