Immunological Response of Bladder Cancer Patients Under BCG

NCT04806178 | Completed Phase 3

• 1 other identifier: BCG IMMUNO Bladder
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Bladder Cancer; Bacillus Calmette-Guerin

Keywords

BCG; Bladder cancer; Immunotherapy

Outcome Measures

Primary Outcomes (6)

• Flow Cytometry

  Cellular Immune Response

  Day 0

• Flow Cytometry

  Cellular Immune Response

  Day 14

• Flow Cytometry

  Cellular Immune Response

  Day 21

• Flow Cytometry

  Cellular Immune Response

  Day 35

• Flow Cytometry

  Cellular Immune Response

  Day 49

• Flow Cytometry

  Cellular Immune Response

  Day 180

Secondary Outcomes (3)

• Adverse Effects and Change from Baseline Voiding Symptoms

  Day 21

• Adverse Effects and Change from Baseline Voiding Symptoms

  Day 35

• Adverse Effects and Change from Baseline Voiding Symptoms

  Day 49

Study Arms (2)

BCG intradermal vaccine

ACTIVE COMPARATOR

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.

Biological: Bacillus Calmette Guerin

Placebo

PLACEBO COMPARATOR

Placebo group (n = 16): 0.9% saline solution in the same volume as BCG vaccine in a single dose.

Other: PLACEBO

Interventions

Bacillus Calmette Guerin BIOLOGICAL

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.

Also known as: BCG

BCG intradermal vaccine

PLACEBO OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NMIBC with the indication for intravesical BCG treatment;

You may not qualify if:

• Previous BCG treatment;
• Muscle invasive tumor.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator
• Pontifical University Catholic of Campinas: collaborator

Study Sites (2)

Pontifical Catholic University of Campinas Hospital

Campinas, São Paulo, 13034685, Brazil

Location

Hospital das Clínicas Unicamp

Campinas, São Paulo, 13083887, Brazil

Location

Related Publications (2)

• 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.

  PMID: 31413921 BACKGROUND

• 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.

  PMID: 32678343 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Leonardo O Reis, MD, PhD

  University of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Livre Docente

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 19, 2021
• Study Start: September 3, 2021
• Primary Completion: May 24, 2024
• Study Completion: August 18, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)