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Active, not recruitingNCT06462001Updated Jun 17, 2024

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

A Phase 3 interventional study of Bacillus Calmette-Guerin Vaccine Intravesical and Mitomycin in Transitional Cell Carcinoma and Transurethral Resection, sponsored by Nottingham University Hospitals NHS Trust. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-17.

Sponsored by Nottingham University Hospitals NHS Trust · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Dec 2020, registered Dec 2023).
Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Transitional Cell Carcinoma
  • Transurethral Resection
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In context

Non-Muscle Invasive Bladder Neoplasms

265 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 113 are open to participants now.

This study's enrollment of 500 is above the median of 70 across 204 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.

Browse Non-Muscle Invasive Bladder Neoplasms studies →

Lead sponsor

Nottingham University Hospitals NHS Trust is the lead sponsor of 104 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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).
  2. Age ≥ 18 yrs
  3. 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.
  4. ECOG Performance Status of 0-2
  5. Adequate bone marrow, renal and liver function confirmed by pre-randomisation blood tests.
  6. Study treatment both planned and able to start within 4 weeks of randomisation
  7. Is willing to complete HRQL questionnaires or is unable to complete them because of literacy, insufficient English or limited vision
  8. Willing and able to comply with all study requirements, including treatment, timing and/or nature of all required assessments
  9. Signed, written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Contraindications or hypersensitivity to investigational products, BCG and MM
  2. Prior treatment with any other intravesical agent including BCG or MM (excludes single doses given post TURBT)
  3. Current or past transitional cell carcinoma (TCC) of the upper urinary tract
  4. Prior muscle-invasive (stage T2 or higher) transitional-cell carcinoma of the bladder
  5. Bladder dysfunction precluding intravesical therapy e.g. Severe urinary incontinence or overactive or spastic bladder
  6. Life expectancy \< 3 months
  7. 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)
  8. Prior radiotherapy of the pelvis
  9. Prior or current treatment with radiotherapy-response or biological-response modifiers
  10. Clinical evidence of existing active tuberculosis
  11. History of another malignancy within 5 years prior to registration. Patients with non-melanomatous carcinoma of the skin are eligible for this study.
  12. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
  13. 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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (actual)

Study arms

  • Active comparator
    Arm A: Standard Intravesical BCG

    Standard intravesical BCG therapy given as per usual standard of care

    Biological: Bacillus Calmette-Guerin Vaccine Intravesical

  • Experimental
    Arm B: Experimental BCG + MM

    Combination therapy with BCG and MM, given on specific protocol sessions

    Biological: Bacillus Calmette-Guerin Vaccine Intravesical · Drug: Mitomycin

Interventions

  • BiologicalBacillus Calmette-Guerin Vaccine Intravesical

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

  • DrugMitomycin

    MMC is administered intravesically as per usual standard of care

06

What researchers measure

Primary outcomes

  1. Disease free survival

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

    Time frame: 5 years follow up

Secondary outcomes

  1. Activity

    Clear cystoscopy at 3 months

    Time frame: 3 months

  2. Time to Recurrence

    Recurrence of TCC bladder

    Time frame: 5 years follow up

  3. Time to Progression

    Recurrence of Higher Grade or Stage

    Time frame: 5 years follow up

  4. Safety and adverse events

    Adverse Events Graded According to CTC AE V4.03

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 5 years follow up

  8. Overall Survival Time

    Death from any Cause

    Time frame: 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

    Time frame: 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

    Time frame: 5 years follow up

Other outcomes

  1. To consider future exploratory biomarker studies as potential prognostic biomarkers or predictive biomarkers of treatment

    Future (as yet unidentified) biomarker expression could be measured and then statistical association of those biomarkers with primary outcome meaures assessed.

    Time frame: 5 years follow up

07

Study locations

1 site
  • Nottingham University Hospitals
    Nottingham, NG51PB, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06462001
Lead sponsor
Nottingham University Hospitals NHS Trust
Collaborators
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, University of Sydney
Responsible party
Sponsor
First posted
Jun 17, 2024
Start date
Dec 10, 2020
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jun 17, 2024

Study contacts

Dickon Hayne, PhD
study director · The University of Western Australia

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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