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Bladder CancerPhase 3IMMUNOBCGNCT04806178

Immunological Response of Bladder Cancer Patients Under BCG

A Phase 3 study testing Bacillus Calmette Guerin in people with Bladder Cancer and Bacillus Calmette-Guerin, run by University of Campinas, Brazil at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bladder cancer (BC) is one of the most common cancers worldwide and the most successful example of vaccine in cancer treatment, representing an efficient model for studying the importance of systemic and local immune mechanisms. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Bacillus Calmette-Guerin
What is being tested?
Bacillus Calmette Guerin
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesBrazil
Study dates
3 Sep 2021to 18 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

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

  • NMIBC with the indication for intravesical BCG treatment;

Who cannot join

  • Previous BCG treatment;
  • Muscle invasive tumor.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Pontifical Catholic University of Campinas Hospital

    Campinas, São Paulo, 13034685

  • Hospital das Clínicas Unicamp

    Campinas, São Paulo, 13083887

Other trials in Brazil

About this study

Official title: Systemic Immunological Response of Bladder Cancer Patients Under Bacillus Calmette Guérin Treatment

Bladder cancer (BC) is one of the most common cancers worldwide and the most successful example of vaccine in cancer treatment, representing an efficient model for studying the importance of systemic and local immune mechanisms. Despite being the standard of treatment for the last 40 years, the exact mode of action of immunotherapy with the bacillus Calmette-Guérin (BCG) is still poorly defined. In a mechanistic study, the investigators intend to prospectively investigate immunological signatures, including immune-checkpoints, pre and post-treatment in patients with BC, and correlate the cytokines of the immune by-product and BCG administration pathway to understand the independent contributions of BCG priming (prior exposure to BCG) and crosstalk immunotherapy between tumor profiles and immune response of the patient. The proposed research strategy is justified by the need to identify subsets of patients who better respond to an intervention, or to predict why new immunotherapies and drugs may be successful or failed in clinical trials.

Read the detailed description

Recognizing patient-to-patient variability, key data scarcity, and insight into traditional reductionist therapy, the BCG model offers exceptionally compelling opportunities to understand how immune system behavior in health and disease emerges from local, systemic, genetic, epigenetic, cellular, and environmental modulating factors.

The application seeks to change the current clinical practice and research paradigms, by using new theoretical concepts, challenging bladder cancer patients with a highly effective, safe, and affordable immunotherapy, the gold standard in the last 40 years of NMIBC, and in light of new concepts and methodologies brought by the paradigm of immune-checkpoint inhibitors that justified the Nobel Prize in Physiology or Medicine in 2018.

The current proposal has the potential to impact the prognosis and identification of those who are unlikely to respond to immune-checkpoint inhibitors, scenarios in which important unanswered questions remain, particularly as this class of agents advances along the spectrum of non-metastatic disease.

In a mechanistic approach, patients diagnosed with NMIBC and with the indication for intravesical BCG treatment will be randomized to placebo versus a priming intradermic BCG 14 days before the intravesical treatment and followed up to 180 days.

The investigators will define important clinical paradigms:

  1. The role of the priming effect on the immune system and better understanding of BCG immunotherapy, with a clear potential for improvement of bladder cancer treatment in NMIBC and MIBC scenarios;
  2. The potential of BCG, a widely used vaccine, to improve or impair the results of new immunotherapies, given its long-lasting effect;
  3. Rational to develop future treatment associations of BCG and immune-checkpoints. \

Under the new immunological concepts, a better understanding of tumor-associated immune responses in BC patients could provide more informed clinical decisions and treatment optimization.

Considering the growing need of assessing the value of treatment at the expense of cost, part of our proposal strategy is to limit financial toxicity as an important issue in cancer treatment and new immunotherapies.

Being tested
Bacillus Calmette Guerin, PLACEBO
Keywords
BCG, Bladder cancer, Immunotherapy
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.

  • Bacillus Calmette GuerinBiological

    Also called BCG

    0.1 ml of lyophilized, live, and attenuated BCG intradermal vaccine, containing between 2 and 8 x 1.000.000 C.F.U in a single dose.

  • PLACEBOOther

    0.1 ml 0.9% saline in the same volume as the BCG vaccine in a single dose.

Study groups in NCT04806178
Study groupRoleWhat they receive
BCG intradermal vaccineActive comparatorIntradermal BCG Group (n=16): 0.1 ml of lyophilized, live, and attenuated BCG intradermal vaccine, containing between 2 and 8 x 1.000.000 C.F.U in a single dose.
Receives: Biological: Bacillus Calmette Guerin
PlaceboPlacebo comparatorPlacebo group (n = 16): 0.9% saline solution in the same volume as BCG vaccine in a single dose.
Receives: Other: PLACEBO

What is being measured

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

  1. Flow Cytometry

    Cellular Immune Response

    Measured: Day 0

  2. Flow Cytometry

    Cellular Immune Response

    Measured: Day 14

  3. Flow Cytometry

    Cellular Immune Response

    Measured: Day 21

  4. Flow Cytometry

    Cellular Immune Response

    Measured: Day 35

  5. Flow Cytometry

    Cellular Immune Response

    Measured: Day 49

  6. Flow Cytometry

    Cellular Immune Response

    Measured: Day 180

Secondary outcomes (3)

  1. Adverse Effects and Change from Baseline Voiding Symptoms

    American Urological Association Symptom Score Questionnaire - minimum 0 and maximum 35, higher scores mean a worse outcome.

    Measured: Day 21

  2. Adverse Effects and Change from Baseline Voiding Symptoms

    American Urological Association Symptom Score Questionnaire - minimum 0 and maximum 35, higher scores mean a worse outcome.

    Measured: Day 35

  3. Adverse Effects and Change from Baseline Voiding Symptoms

    American Urological Association Symptom Score Questionnaire - minimum 0 and maximum 35, higher scores mean a worse outcome.

    Measured: Day 49

Timeline

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

  1. First posted19 Mar 2021
  2. Study start3 Sep 2021
  3. Primary completion24 May 2024
  4. Study completion18 Aug 2024

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04806178
Sponsor's protocol ID
BCG IMMUNO Bladder
Acronym
IMMUNOBCG
Status last verified
Dec 2024
First submitted
12 Mar 2021
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ji N, Mukherjee N, Morales EE, Tomasini ME, Hurez V, Curiel TJ, Abate G, Hoft DF, Zhao XR, Gelfond J, Maiti S, Cooper LJN, Svatek RS. Percutaneous BCG enhances innate effector antitumor cytotoxicity during treatment of bladder cancer: a translational clinical trial. Oncoimmunology. 2019 May 25;8(8):1614857. doi: 10.1080/2162402X.2019.1614857. eCollection 2019.

    PubMed 31413921

  • van Puffelen JH, Keating ST, Oosterwijk E, van der Heijden AG, Netea MG, Joosten LAB, Vermeulen SH. Trained immunity as a molecular mechanism for BCG immunotherapy in bladder cancer. Nat Rev Urol. 2020 Sep;17(9):513-525. doi: 10.1038/s41585-020-0346-4. Epub 2020 Jul 16.

    PubMed 32678343

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bacillus Calmette Guerin in people with Bladder Cancer and Bacillus Calmette-Guerin, run by University of Campinas, Brazil at 2 sites in Brazil.

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 1 inclusion and 2 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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Flow Cytometry (time frame: Day 0). The study lists 6 primary outcomes in all. 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 NCT04806178, which also lists 2 linked publications.

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 9 Dec 2024.

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