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Transitional Cell CarcinomaPhase 3NCT06462001

BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer

A Phase 3 study testing Bacillus Calmette-Guerin Vaccine Intravesical and Mitomycin in people with Transitional Cell Carcinoma and Transurethral Resection, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.

Active, not recruiting

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

Official record
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Trial summary

Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non-muscle-invasive bladder cancer (NMIBC), but over 30% of people still develop recurrent transitional cell… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bacillus Calmette-Guerin Vaccine Intravesical and Mitomycin
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited Kingdom
Study dates
10 Dec 2020to 1 Dec 2026
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

  • Males or females with confirmed high grade pTa or stage pT1 (any grade) non-muscle invasive bladder cancer on initial or re-resection histology (concurrent carcinoma in situ is allowed).
  • Age ≥ 18 yrs
  • No macroscopically visible disease at cystoscopy within 8 weeks prior to randomisation. This may either be the initial TURBT at which the primary tumour was completely resected, or a planned second cystoscopy and/ or re-resection done within 8 weeks of the initial TURBT.
  • ECOG Performance Status of 0-2
  • Adequate bone marrow, renal and liver function confirmed by pre-randomisation blood tests.
  • Study treatment both planned and able to start within 4 weeks of randomisation
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  • Is willing to complete HRQL questionnaires or is unable to complete them because of literacy, insufficient English or limited vision
  • Willing and able to comply with all study requirements, including treatment, timing and/or nature of all required assessments
  • Signed, written informed consent

Who cannot join

  • Contraindications or hypersensitivity to investigational products, BCG and MM
  • Prior treatment with any other intravesical agent including BCG or MM (excludes single doses given post TURBT)
  • Current or past transitional cell carcinoma (TCC) of the upper urinary tract
  • Prior muscle-invasive (stage T2 or higher) transitional-cell carcinoma of the bladder
  • Bladder dysfunction precluding intravesical therapy e.g. Severe urinary incontinence or overactive or spastic bladder
  • Life expectancy < 3 months
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  • Congenital or acquired immune deficiencies, whether due to a concurrent disease (e.g. acquired immune deficiency syndrome (AIDS), leukaemia, lymphoma) or immunosuppressive therapy (e.g. corticosteroids), or cancer therapy (cytotoxic drugs, radiation)
  • Prior radiotherapy of the pelvis
  • Prior or current treatment with radiotherapy-response or biological-response modifiers
  • Clinical evidence of existing active tuberculosis
  • History of another malignancy within 5 years prior to registration. Patients with non-melanomatous carcinoma of the skin are eligible for this study.
  • Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
  • Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Nottingham University Hospitals

    Nottingham, NG51PB

Other trials in United Kingdom

About this study

Official title: BCG + MMC: Adding Mitomycin C to BCG as Adjuvant Intravesical Therapy for High-risk, Non-muscle-invasive Bladder Cancer: a Randomised Phase 3 Trial

Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non-muscle-invasive bladder cancer (NMIBC), but over 30% of people still develop recurrent transitional cell carcinoma (TCC) despite optimal therapy with adjuvant intravesical BCG. Our meta-analysis, including a recent randomised phase 2 trial, suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both Mitomycin (MM) and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase 3 trial using standard techniques for intravesical administration.

Being tested
Bacillus Calmette-Guerin Vaccine Intravesical, Mitomycin
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

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

  • Bacillus Calmette-Guerin Vaccine IntravesicalBiological

    BCG (Oncotice) is administered intravesically as per usual standard of care

  • MitomycinDrug

    MMC is administered intravesically as per usual standard of care

Study groups in NCT06462001
Study groupRoleWhat they receive
Arm A: Standard Intravesical BCGActive comparatorStandard intravesical BCG therapy given as per usual standard of care
Receives: Biological: Bacillus Calmette-Guerin Vaccine Intravesical
Arm B: Experimental BCG + MMExperimentalCombination therapy with BCG and MM, given on specific protocol sessions
Receives: Biological: Bacillus Calmette-Guerin Vaccine Intravesical; Drug: Mitomycin

What is being measured

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

  1. Disease free survival

    Death, disease free survival, or evidence of transitional cell carcinoma (TCC)

    Measured: 5 years follow up

Secondary outcomes (10)

  1. Activity

    Clear cystoscopy at 3 months

    Measured: 3 months

  2. Time to Recurrence

    Recurrence of TCC bladder

    Measured: 5 years follow up

  3. Time to Progression

    Recurrence of Higher Grade or Stage

    Measured: 5 years follow up

  4. Safety and adverse events

    Adverse Events Graded According to CTC AE V4.03

    Measured: During treatment phase of the trial (typically 12 months)

  5. Health-Related Quality of Life

    QLQ-BLS24. Individual internationally-validated (but subjective) symptom score questionnaire that gives an overall QOL assesment, that can be tracked throughout follow up. They do not use SI units of measurement.

    Measured: 5 years follow up

  6. Health-Related Quality of Life

    QLQ-C30. Individual internationally-validated (but subjective) symptom score questionnaire that gives an overall QOL assesment, that can be tracked throughout follow up. They do not use SI units of measurement.

    Measured: 5 years follow up

  7. Health-Related Quality of Life

    I-PSS. Individual internationally-validated (but subjective) symptom score questionnaire that gives an overall QOL assesment, that can be tracked throughout follow up. They do not use SI units of measurement.

    Measured: 5 years follow up

  8. Overall Survival Time

    Death from any Cause

    Measured: 5 years follow up

  9. Feasibility as a future standard of care

    Compliance with intravesical therapy, measured in percent (%) of planned intravesical therapies actually given

    Measured: During treatment phase of the trial, typically 1 year

  10. Marginal Resource Use

    Number of GP visits, Number of outpatient and emergency department visits, number of inpatient admissions and number of days admitted

    Measured: 5 years follow up

Timeline

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

  1. First posted17 Jun 2024
  2. Study start10 Dec 2020
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
an open label, randomised, stratified, 2-arm multicentre phase 3 clinical trial
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06462001
Sponsor's protocol ID
18UR004
Status last verified
Jun 2024
First submitted
29 Dec 2023
Last updated
17 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bacillus Calmette-Guerin Vaccine Intravesical and Mitomycin in people with Transitional Cell Carcinoma and Transurethral Resection, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.

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 9 inclusion and 13 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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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 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?

Disease free survival (time frame: 5 years follow up). 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 NCT06462001.

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 17 Jun 2024.

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