- |||||||||| 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
- |||||||||| Proleukin (aldesleukin) / Novartis, Prometheus, 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IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov) - Feb 14, 2023 P2/3, N=0, Withdrawn, Trial completion date: Mar 2022 --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 Withdrawn | Trial primary completion date: Dec 2031 --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.
- |||||||||| Proleukin (aldesleukin) / Novartis, Prometheus, 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
- |||||||||| 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
- |||||||||| 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) / Novartis, Prometheus, 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
- |||||||||| Proleukin (aldesleukin) / Novartis, Prometheus, 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: 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
- |||||||||| 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) - Jul 23, 2020 P1, N=20, Active, not recruiting, Recruiting --> Active, not recruiting | N=27 --> 9 | Trial completion date: Feb 2020 --> Feb 2022 | Trial primary completion date: Jan 2020 --> May 2020 Phase classification: P3 --> P1 | N=600 --> 20 | Trial completion date: May 2020 --> Nov 2020 | Trial primary completion date: Apr 2020 --> Oct 2020
- |||||||||| Proleukin (aldesleukin) / Novartis, Prometheus, Iovance Biotherap, Tice BCG (live attenuated bacillus Calmette-Guerin) / Merck (MSD), Texas A&M University
Enrollment change, Trial completion date, Trial primary completion date, Metastases: The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov) - Apr 12, 2020 P2/3, N=100, Not yet recruiting, Our results suggest that activation of STING signaling by recombinant BCG overexpressing STING is a promising approach to enhance the antitumor immune responses and may be valuable as an adjuvant treatment of patients with high risk NMIBC. N=40 --> 100 | Trial completion date: Jan 2030 --> Sep 2030 | Trial primary completion date: Jan 2025 --> Sep 2025
- |||||||||| Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Gu (clinicaltrials.gov) - Feb 17, 2020 P1/2, N=24, Active, not recruiting, N=40 --> 100 | Trial completion date: Jan 2030 --> Sep 2030 | Trial primary completion date: Jan 2025 --> Sep 2025 Trial completion date: Mar 2020 --> Feb 2021 | Trial primary completion date: Dec 2019 --> Sep 2020
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