Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University 
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  • ||||||||||  Verity-BCG (Strain Russian BCG-I) / Verity Pharma
    Enrollment open, Trial completion date:  EVER: Evaluating Safety and Efficacy of Verity-BCG in BCG-na (clinicaltrials.gov) -  Feb 20, 2025   
    P3,  N=540, Recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Jan 2026 --> Feb 2029
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Journal:  BCG-therapy for non-muscle-invasive bladder cancer: overview of the current trends (Pubmed Central) -  Nov 20, 2024   
    According to the survey, one third of doctors do not prescribe BCG therapy due to the lack of conditions or a shortage of the drug. An increase of relapse-free survival of patients with NMIBC is possible by providing conditions for intravesical immunotherapy.
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Trial completion, Enrollment change:  Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections (clinicaltrials.gov) -  Jan 16, 2024   
    P2,  N=29, Completed, 
    Active, not recruiting --> Completed Recruiting --> Completed | N=180 --> 29
  • ||||||||||  abiraterone acetate / Generic mfg.
    Biomarker, Phase classification, Enrollment change, Trial completion date, Trial primary completion date:  Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms (clinicaltrials.gov) -  Aug 31, 2023   
    P2/3,  N=600, Active, not recruiting, 
    Recruiting --> Active, not recruiting Phase classification: P1 --> P2/3 | N=20 --> 600 | Trial completion date: Oct 2023 --> May 2024 | Trial primary completion date: Oct 2023 --> May 2024
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Trial completion date, Trial primary completion date:  Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections (clinicaltrials.gov) -  Jun 9, 2023   
    P2,  N=180, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
  • ||||||||||  BCG Tokyo-172 Strain Vaccine / Japan BCG Laboratory, Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Trial primary completion date:  S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (clinicaltrials.gov) -  Mar 2, 2023   
    P3,  N=1000, Active, not recruiting, 
    Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023 Trial primary completion date: Feb 2023 --> Dec 2024
  • ||||||||||  abiraterone acetate / Generic mfg.
    Biomarker, Trial completion date, Trial primary completion date:  Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms (clinicaltrials.gov) -  Feb 14, 2023   
    P1,  N=20, Active, not recruiting, 
    Trial primary completion date: Feb 2023 --> Dec 2024 Trial completion date: Mar 2022 --> Oct 2023 | Trial primary completion date: Mar 2022 --> Oct 2023
  • ||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Metastases:  The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov) -  Feb 14, 2023   
    P2/3,  N=0, Withdrawn, 
    Trial completion date: Mar 2022 --> Oct 2023 | Trial primary completion date: Mar 2022 --> Oct 2023 N=100 --> 0 | Trial completion date: Dec 2031 --> Sep 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2031 --> Sep 2022
  • ||||||||||  gemcitabine / Generic mfg.
    A phase II trial of intravesical chemoimmunotherapy with gemcitabine and bacillus Calmette-Gu (On Demand | Level 1, West Hall; Poster Board No. P2) -  Jan 10, 2023 - Abstract #ASCOGU2023ASCO_GU_673;    
    P1/2
    Combination BCG with immune checkpoint inhibition is associated with a ~12-18% risk of serious treatment-related adverse events and BCG combined with Mitomycin C (MMC) has unacceptable urinary toxicity...The maximum tolerated dose (MTD) was 2000 mg gemcitabine and 50 mg TICE BCG...Correlative studies explore immune and molecular predictors of response and resistance to chemoimmunotherapy in tumor tissue, urine, and blood. Clinical trial information: NCT04179162.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Enrollment closed, Trial completion date, IO biomarker:  NU 15U06: Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov) -  Oct 20, 2022   
    P1,  N=9, Active, not recruiting, 
    Recruiting --> Completed | Trial completion date: Dec 2022 --> Aug 2022 | Trial primary completion date: Dec 2022 --> Aug 2022 Unknown status --> Active, not recruiting | Trial completion date: Feb 2022 --> Feb 2023
  • ||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Trial completion date, Trial primary completion date, Metastases:  The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov) -  Jul 19, 2022   
    P2/3,  N=100, Not yet recruiting, 
    Unknown status --> Recruiting | Trial completion date: Dec 2020 --> Dec 2024 | Trial primary completion date: Dec 2020 --> Dec 2024 Trial completion date: Jul 2031 --> Dec 2031 | Trial primary completion date: Jul 2031 --> Dec 2031
  • ||||||||||  Verity-BCG (Strain Russian BCG-I) / Verity Pharma
    Trial completion date, Trial initiation date, Trial primary completion date, Head-to-Head:  EVER: Evaluating Safety and Efficacy of Verity-BCG in BCG-na (clinicaltrials.gov) -  Apr 8, 2022   
    P3,  N=540, Not yet recruiting, 
    Trial primary completion date: Apr 2022 --> Apr 2024 Trial completion date: Aug 2026 --> Jan 2026 | Initiation date: Jan 2022 --> Jun 2022 | Trial primary completion date: Jul 2025 --> Dec 2025
  • ||||||||||  BCG Tokyo-172 Strain Vaccine / Japan BCG Laboratory, Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Trial primary completion date:  S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (clinicaltrials.gov) -  Mar 10, 2022   
    P3,  N=1000, Active, not recruiting, 
    Trial completion date: Aug 2026 --> Jan 2026 | Initiation date: Jan 2022 --> Jun 2022 | Trial primary completion date: Jul 2025 --> Dec 2025 Trial primary completion date: Feb 2022 --> Feb 2023
  • ||||||||||  abiraterone acetate / Generic mfg.
    Biomarker, Trial completion date, Trial primary completion date:  Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms (clinicaltrials.gov) -  Jan 14, 2022   
    P1,  N=20, Active, not recruiting, 
    However, no significant differences were detected for PFS and CSS, respectively. Trial completion date: Jul 2022 --> Mar 2022 | Trial primary completion date: Jun 2022 --> Mar 2022
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Trial completion date, Trial primary completion date, Adverse events:  Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) -  Nov 16, 2021   
    P2,  N=45, Recruiting, 
    Trial completion date: Jul 2022 --> Mar 2022 | Trial primary completion date: Jun 2022 --> Mar 2022 Trial completion date: Jan 2022 --> Dec 2022 | Trial primary completion date: Jan 2022 --> Dec 2022
  • ||||||||||  Tecentriq (atezolizumab) / Roche
    Trial termination, Combination therapy:  Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Gu (clinicaltrials.gov) -  Oct 28, 2021   
    P1/2,  N=24, Terminated, 
    Trial completion date: Jan 2022 --> Dec 2022 | Trial primary completion date: Jan 2022 --> Dec 2022 Completed --> Terminated; The study was terminated early as the study had met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Novel microbial immunotherapy approach for the treatment of bladder cancer (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_1160;    
    Tumor-bearing animals were treated with a single intravesical dose of ZH9 or OncoTice BCG and long-term survival comparisons were evaluated by log-rank (Mantel-Cox) test...ZH9 demonstrated direct tumour cell killing in vitro and induction of robust cellular immune responses in vivo. Preclinical studies indicate significant therapeutic potential of intravesical ZH9 as a novel microbial immunotherapy in bladder cancer.
  • ||||||||||  abiraterone acetate / Generic mfg.
    Biomarker, Trial completion date, Trial primary completion date:  Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms (clinicaltrials.gov) -  Sep 1, 2021   
    P1,  N=20, Active, not recruiting, 
    Preclinical studies indicate significant therapeutic potential of intravesical ZH9 as a novel microbial immunotherapy in bladder cancer. Trial completion date: Jun 2021 --> Jul 2022 | Trial primary completion date: Jun 2021 --> Jun 2022
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    [VIRTUAL] Extracellular Vesicles: a mechanism of action of Bacillus Calmette-Guerin and a potential biomarker () -  Aug 5, 2021 - Abstract #AUA2021AUA_1364;    
    We showed that BCG promotes the release of immuno-active EVs by BC cells. Those EVsBCG can directly activate dendritic cells to modulate BCG-induced anti-tumor host response that warrants the therapeutic benefit of EVsBCG as an adjuvant therapy. Together, these data suggest that BCEVs play an important role in the mechanism of action of BCG immunotherapy.
  • ||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Trial completion date, Trial primary completion date, Metastases:  The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov) -  Jun 29, 2021   
    P2/3,  N=100, Not yet recruiting, 
    Those EVsBCG can directly activate dendritic cells to modulate BCG-induced anti-tumor host response that warrants the therapeutic benefit of EVsBCG as an adjuvant therapy. Together, these data suggest that BCEVs play an important role in the mechanism of action of BCG immunotherapy. Trial completion date: Apr 2026 --> Jul 2031 | Trial primary completion date: Apr 2026 --> Jul 2031
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date:  NUEVA: BCG Vaccination to Prevent COVID-19 (clinicaltrials.gov) -  Mar 26, 2021   
    P3,  N=0, Withdrawn, 
    Trial primary completion date: Nov 2023 --> Nov 2025 N=550 --> 0 | Trial completion date: Jun 2022 --> Mar 2021 | Recruiting --> Withdrawn | Trial primary completion date: Jun 2022 --> Mar 2021
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Trial completion date, Trial primary completion date:  NUEVA: BCG Vaccination to Prevent COVID-19 (clinicaltrials.gov) -  Mar 12, 2021   
    P3,  N=550, Recruiting, 
    N=550 --> 0 | Trial completion date: Jun 2022 --> Mar 2021 | Recruiting --> Withdrawn | Trial primary completion date: Jun 2022 --> Mar 2021 Trial completion date: Apr 2023 --> Jun 2022 | Trial primary completion date: Nov 2022 --> Jun 2022
  • ||||||||||  BCG Tokyo-172 Strain Vaccine / Japan BCG Laboratory, Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Enrollment closed:  S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (clinicaltrials.gov) -  Feb 24, 2021   
    P3,  N=1000, Active, not recruiting, 
    Trial completion date: Apr 2023 --> Jun 2022 | Trial primary completion date: Nov 2022 --> Jun 2022 Recruiting --> Active, not recruiting
  • ||||||||||  abiraterone acetate / Generic mfg.
    Biomarker, Trial completion date, Trial primary completion date:  Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms (clinicaltrials.gov) -  Feb 24, 2021   
    P1,  N=20, Active, not recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Nov 2020 --> Jun 2021 | Trial primary completion date: Oct 2020 --> Jun 2021
  • ||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Trial completion date, Trial primary completion date, Metastases:  The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov) -  Jan 27, 2021   
    P2/3,  N=100, Not yet recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Sep 2030 --> Apr 2026 | Trial primary completion date: Sep 2025 --> Apr 2026
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    Enrollment open:  NUEVA: BCG Vaccination to Prevent COVID-19 (clinicaltrials.gov) -  Dec 9, 2020   
    P3,  N=550, Recruiting, 
    Trial completion date: Sep 2030 --> Apr 2026 | Trial primary completion date: Sep 2025 --> Apr 2026 Not yet recruiting --> Recruiting
  • ||||||||||  Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
    New P3 trial:  NUEVA: BCG Vaccination to Prevent COVID-19 (clinicaltrials.gov) -  Nov 17, 2020   
    P3,  N=550, Not yet recruiting, 
  • ||||||||||  Tecentriq (atezolizumab) / Roche
    Trial completion, Trial completion date, Combination therapy:  Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Gu (clinicaltrials.gov) -  Nov 13, 2020   
    P1/2,  N=24, Completed, 
    Longer-term follow up to assess the true frequency of durable responses at 12-months and beyond as well as validation of predictive biomarkers associated with durable responses is warranted. Active, not recruiting --> Completed | Trial completion date: Feb 2021 --> Sep 2020
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, IO biomarker:  NU 15U06: Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov) -  Sep 15, 2020   
    P1,  N=9, Active, not recruiting, 
    N=550 --> 1525 Recruiting --> Active, not recruiting | N=27 --> 9 | Trial completion date: Feb 2020 --> Feb 2022 | Trial primary completion date: Jan 2020 --> May 2020