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DRUG:

Tice BCG (live attenuated bacillus Calmette-Guerin)

i
Other names: BCG vaccine
Associations
Company:
Merck (MSD), Texas A&M University
Drug class:
Immunostimulant
Related drugs:
Associations
4d
Enrollment closed • Combination therapy
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Keytruda (pembrolizumab) • Tice BCG (live attenuated bacillus Calmette-Guerin)
2ms
ALBAN: Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients (clinicaltrials.gov)
P3, N=516, Active, not recruiting, UNICANCER | Trial completion date: Feb 2028 --> Oct 2028 | Trial primary completion date: Apr 2024 --> Oct 2024
Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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Tecentriq (atezolizumab) • Tice BCG (live attenuated bacillus Calmette-Guerin)
5ms
Trial completion • IO biomarker
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PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • PD-L2 (Programmed Cell Death 1 Ligand 2)
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Keytruda (pembrolizumab) • Tice BCG (live attenuated bacillus Calmette-Guerin)
10ms
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections (clinicaltrials.gov)
P2, N=29, Completed, Johns Hopkins University | Recruiting --> Completed | N=180 --> 29
Trial completion • Enrollment change
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IFNG (Interferon, gamma)
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Tice BCG (live attenuated bacillus Calmette-Guerin)
12ms
Enrollment closed
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PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
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Tecentriq (atezolizumab) • Tice BCG (live attenuated bacillus Calmette-Guerin)
over1year
BCG+MMC: Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer (clinicaltrials.gov)
P3, N=501, Active, not recruiting, University of Sydney | Recruiting --> Active, not recruiting
Enrollment closed
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mitomycin • TheraCys (PMCJ-9) • Tice BCG (live attenuated bacillus Calmette-Guerin)
over1year
Genetically engineered Salmonella Typhi as novel microbial immunotherapy for bladder cancer (EACR 2023)
We established the preclinical safety and efficacy of live-attenuated Salmonella enterica Typhi strain ZH9 as a novel immunotherapy for NMIBC.Material and MethodsZH9 efficacy and mechanism of action (MOA) were tested in the murine orthotopic, syngeneic MB49 tumor model, compared to OncoTICE®BCG...Systemic priming further enhances immune responses and may therefore result in greater efficacy. This suggests that ZH9 immunotherapy may improve outcomes for patients with NMIBC, allowing less aggressive treatment and more reliable manufacturing method than the current SOC.
IO biomarker
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Tice BCG (live attenuated bacillus Calmette-Guerin)
almost2years
The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov)
P2/3, N=0, Withdrawn, Carman Giacomantonio | N=100 --> 0 | Trial completion date: Dec 2031 --> Sep 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2031 --> Sep 2022
Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Metastases
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IL2 (Interleukin 2)
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Proleukin (aldesleukin) • Tice BCG (live attenuated bacillus Calmette-Guerin)
over2years
The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov)
P2/3, N=100, Not yet recruiting, Carman Giacomantonio | Trial completion date: Jul 2031 --> Dec 2031 | Trial primary completion date: Jul 2031 --> Dec 2031
Trial completion date • Trial primary completion date
|
IL2 (Interleukin 2)
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Proleukin (aldesleukin) • Tice BCG (live attenuated bacillus Calmette-Guerin)
over2years
Selective delipidation of Mycobacterium bovis BCG retains antitumor efficacy against non-muscle invasive bladder cancer. (PubMed, Cancer Immunol Immunother)
These data support clinical investigation of dBCG-Tokyo as a treatment for patients with BCG-intolerant NMIBC.
Journal
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • GZMB (Granzyme B)
|
Tice BCG (live attenuated bacillus Calmette-Guerin)
over2years
Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Tecentriq (atezolizumab) • Tice BCG (live attenuated bacillus Calmette-Guerin)
over3years
The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov)
P2/3, N=100, Not yet recruiting, Carman Giacomantonio | Trial completion date: Apr 2026 --> Jul 2031 | Trial primary completion date: Apr 2026 --> Jul 2031
Trial completion date • Trial primary completion date
|
IL2 (Interleukin 2)
|
Proleukin (aldesleukin) • Tice BCG (live attenuated bacillus Calmette-Guerin)
almost4years
The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov)
P2/3, N=100, Not yet recruiting, Carman Giacomantonio | Trial completion date: Sep 2030 --> Apr 2026 | Trial primary completion date: Sep 2025 --> Apr 2026
Trial completion date • Trial primary completion date
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IL2 (Interleukin 2)
|
Proleukin (aldesleukin) • Tice BCG (live attenuated bacillus Calmette-Guerin)
4years
[VIRTUAL] PHASE 1 TRIAL OF DURVALUMAB IN COMBINATION WITH BCG OR EXTERNAL BEAM RADIATION IN BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS (HCRN GU16-243: ADAPT-BLADDER TRIAL) (SUO 2020)
TICE BCG 50 mg was administered intravesically weekly x 6 weeks with maintenance therapy per the treating urologist’s discretion. Durvalumab in combination with intravesical BCG therapy or EBRT can be safely administered to NMIBC patients. Complete response rates in the treated BCG-unresponsive NMIBC population are promising with no unexpected adverse events observed. 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.
Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1)
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Imfinzi (durvalumab) • Tice BCG (live attenuated bacillus Calmette-Guerin)
over4years
The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma (clinicaltrials.gov)
P2/3, N=100, Not yet recruiting, Carman Giacomantonio | N=40 --> 100 | Trial completion date: Jan 2030 --> Sep 2030 | Trial primary completion date: Jan 2025 --> Sep 2025
Enrollment change • Trial completion date • Trial primary completion date
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IL2 (Interleukin 2)
|
Proleukin (aldesleukin) • Tice BCG (live attenuated bacillus Calmette-Guerin)
over5years
Enrollment open • Clinical
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PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
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Tecentriq (atezolizumab) • Tice BCG (live attenuated bacillus Calmette-Guerin)
almost6years
New P3 trial • Clinical
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PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
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Tecentriq (atezolizumab) • Tice BCG (live attenuated bacillus Calmette-Guerin)