BCG vaccine / University of Campinas - LARVOL DELTA

Intradermal priming to intravesical Bacillus Calmette-Guérin in non-muscle invasive bladder cancer: A translational research and phase I clinical trial. (PubMed, Oncol Res) - P3 | "Twenty-one non-muscle invasive urothelial bladder cancer patients undergoing intravesical adjuvant BCG after transurethral resection of bladder tumor (TURBT) in a teaching hospital between September 2021 and April 2023 were randomized to 0.1 mL of intradermal BCG vaccine or placebo (0.9% saline) administered 15 days before the start of intravesical BCG therapy...There was no difference in adverse effects emerging from the intravesical Onco-BCG therapy, and no difference in the expression of the cytokines and proteases analyzed between control and intervention, and over time...Other immune targets should be explored in the future. The Brazilian tuberculosis-endemic status, where BCG vaccination is mandatory, might have affected the results."

Clinical • Journal • P1 data • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Tuberculosis • AXL • CASP8 • IFITM3 • IFNB1 • IL10 • IL1B • IL2RA • IL6 • TNFA

Viral infections and immune modulation in bladder cancer: implications for immunotherapy. (PubMed, Explor Target Antitumor Ther) - "This review explores the intricate relationship between viral infections and Bacillus Calmette-Guerin (BCG) efficacy, emphasizing immune modulation mechanisms that may influence treatment outcomes...A deeper understanding of viral-induced immune dysregulation may improve prognostic assessment, optimize treatment protocols, and reduce healthcare costs associated with bladder cancer. Future research should focus on targeted interventions to mitigate the immunosuppressive effects of chronic infections, ultimately improving patient outcomes in NMIBC management."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Immunology • Infectious Disease • Oncology • Solid Tumor • Urothelial Cancer

IMMUNOBCG: Immunological Response of Bladder Cancer Patients Under BCG (clinicaltrials.gov) - P3 | N=30 | Completed | Sponsor: University of Campinas, Brazil | Suspended ➔ Completed | Trial completion date: Dec 2028 ➔ Aug 2024 | Trial primary completion date: Dec 2026 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Therapeutic BCG vaccine protects against long COVID: The BATTLE randomized clinical trial. (PubMed, J Intern Med) - "Not tested for previous mycobacterial exposure; loss to follow-up, particularly at 12 months."

Clinical • Journal • Alopecia • Immunology • Infectious Disease • Novel Coronavirus Disease • Otorhinolaryngology • Respiratory Diseases • FASLG • IFITM3 • IL10 • IL6

Relevance of immune tumor microenvironment and its interaction with HABP4 and SERBP1 proteins in bladder cancer. (ASCO 2024) - "The samples were divided into three groups (n = 10 samples per group): Group 1 - Initial Non-Muscle Invasive Bladder Cancer (NMIBC); Group 2 - Bacillus Calmette-Guerin (BCG)-unresponsive NMIBC; and Group 3 - Muscle Invasive Bladder Cancer... The augmented presence of Foxp3+Treg cells and CD163+M2 macrophages, concomitant with SERBP1 overexpression and the decrease of immune checkpoints, likely compromises the therapeutic efficacy of BCG. This immunosuppressive milieu hinders the activation, proliferation, and effector functions of CD8+ T cells, thereby promoting tumor progression. Conversely, a heightened infiltration of CX3CR1+CD8+ T cells and iNOS+M1 macrophages promotes a cytotoxic microenvironment, rendering it more amenable to immunotherapeutic interventions."

Biomarker • IO biomarker • Tumor microenvironment • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD163 • CD8 • CX3CR1 • FOXP3 • IFNG • PD-L1

IMMUNOBCG: Immunological Response of Bladder Cancer Patients Under BCG (clinicaltrials.gov) - P3 | N=30 | Suspended | Sponsor: University of Campinas, Brazil | Trial completion date: Nov 2023 ➔ Dec 2028 | Completed ➔ Suspended | Trial primary completion date: May 2022 ➔ Dec 2026

Trial completion date • Trial primary completion date • Trial suspension • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

IMMUNOBCG: Immunological Response of Bladder Cancer Patients Under BCG (clinicaltrials.gov) - P3 | N=30 | Completed | Sponsor: University of Campinas, Brazil | Active, not recruiting ➔ Completed

Trial completion • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Castration immunoregulates toll-like receptor-4 in male bladder cancer. (PubMed, Int Urol Nephrol) - "To our knowledge, this is the first description of TLR-4 urothelial expression hormonal modulation. The described castration-mediated immunomodulation will help to improve the knowledge of urothelial cancer gender diversities and PRRs modulations with treatment implications."

IO biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Solid Tumor • Urothelial Cancer • TLR4

BCG vaccine safety in COVID-19 convalescent adults: BATTLE a randomized controlled trial. (PubMed, Vaccine) - P4 | "The BCG revaccination is safe in convalescent COVID-19 adults of a tuberculosis endemic region, regardless of tuberculin or IGRA test results. Local adverse events were similar though occurred earlier to that previously reported in children."

Journal • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Randomized clinical trial of BCG vaccine in patients with convalescent COVID-19: Clinical evolution, adverse events, and humoral immune response. (PubMed, J Intern Med) - P4 | "No severely ill patients were included."

Adverse events • Clinical • Journal • Dermatology • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

IMMUNOBCG: Immunological Response of Bladder Cancer Patients Under BCG (clinicaltrials.gov) - P3 | N=32 | Active, not recruiting | Sponsor: University of Campinas, Brazil | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor • Urothelial Cancer

OncoTherad® (MRB-CFI-1) nano-immunotherapy reduced tumoral progression in non-muscle invasive bladder cancer through activation of Toll-like signaling pathway. (PubMed, Tissue Cell) - "The new modalities for treating patients with high-grade non-muscle invasive bladder cancer (HGNMIBC) for whom Bacillus Calmette-Guerin (BCG) has failed or is contraindicated are recently increasing due to the development of new drugs...Immunohistochemical analysis demonstrated that while the conventional BCG treatment stimulated the canonic pathway, OncoTherad® (MRB-CFI-1) stimulated the non-canonical pathway (increasing expression of TLR4, TRIF, IRF, and IFNγ). OncoTherad® (MRB-CFI-1) could be considered a promising therapy in the treatment of NMIBC."

IO biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor • Urothelial Cancer • IFNG • IL6 • MYD88 • TNFA

Effective combined antiretroviral therapy provides partial immune recovery to mycobacterial antigens in vertically infected, BCG-vaccinated youth living with HIV. (PubMed, Tuberculosis (Edinb)) - "Even under long-term cART, YLHIV seem to have a suboptimal T-helper-1 response to mycobacterial antigens. This can be explained by early immunodeficiency in vertical infection, with lasting damage."

Journal • Human Immunodeficiency Virus • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8 • IFNG • IL10 • IL17A • IL2 • IL4 • IL5 • TNFA

Impact of intravesical instillation of a novel biological response modifier (P-MAPA) on progress of non-muscle invasive bladder cancer treatment in a rat model. (PubMed, Med Oncol) - "After treatment with MNU, the rats were distributed into four experimental groups: Control (without MNU) group, MNU (cancer) group, MNU-BCG (Bacillus Calmette-Guerin) group, and MNU-P-MAPA group...These alterations were fundamental for histopathological recovery from cancer and for suppress abnormal cell proliferation. This action of P-MAPA on apoptotic pathways may represent a new strategy for treating NMIBC."

Journal • Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • MYC

[VIRTUAL] Carcinogenesis and Bacillus Calmette-Guerin (BCG) Intravesical Treatment of Non-Muscle Invasive Bladder Cancer Under Tryptophan and Thymine Supplementation (AUA 2021) - "Tryptophan and thymine inhibit urothelial carcinogenesis and potentiate the intravesical BCG in the treatment of bladder cancer by reducing cell proliferation and activating TLRs."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • TLR4

IMMUNOBCG: Immunological Response of Bladder Cancer Patients Under BCG (clinicaltrials.gov) - P3; N=32; Recruiting; Sponsor: University of Campinas, Brazil

Clinical • New P3 trial • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor • Urothelial Cancer