Immunological Response of Bladder Cancer Patients Under BCG
NCT ID: NCT04806178
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2021-09-03
2024-08-18
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BCG intradermal vaccine
Intradermal 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.
Bacillus Calmette Guerin
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.
Placebo
Placebo group (n = 16): 0.9% saline solution in the same volume as BCG vaccine in a single dose.
PLACEBO
0.1 ml 0.9% saline in the same volume as the BCG vaccine in a single dose.
Interventions
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Bacillus Calmette Guerin
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.
PLACEBO
0.1 ml 0.9% saline in the same volume as the BCG vaccine in a single dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Muscle invasive tumor.
18 Years
ALL
No
Sponsors
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Coordination for the Improvement of Higher Education Personnel
OTHER
Pontifical University Catholic of Campinas
OTHER
University of Campinas, Brazil
OTHER
Responsible Party
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Leonardo Oliveira Reis
Professor Livre Docente
Principal Investigators
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Leonardo O Reis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Campinas
Locations
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Pontifical Catholic University of Campinas Hospital
Campinas, São Paulo, Brazil
Hospital das Clínicas Unicamp
Campinas, São Paulo, Brazil
Countries
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References
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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.
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.
Other Identifiers
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BCG IMMUNO Bladder
Identifier Type: -
Identifier Source: org_study_id