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Bacillus Calmette-Guerin Vaccine Intravesical
Bacillus Calmette-Guerin Vaccine Intravesical is a Live attenuated vaccine / Immunotherapy Biologic drug developed by Nottingham University Hospitals NHS Trust. It is currently in Phase 3 development for Non-muscle-invasive bladder cancer (NMIBC), high-grade urothelial carcinoma, Bladder cancer recurrence prevention.
BCG vaccine stimulates the immune system to recognize and destroy bladder cancer cells when instilled directly into the bladder.
BCG vaccine stimulates the immune system to recognize and destroy bladder cancer cells when instilled directly into the bladder. Used for Non-muscle-invasive bladder cancer (NMIBC), high-grade urothelial carcinoma, Bladder cancer recurrence prevention.
At a glance
| Generic name | Bacillus Calmette-Guerin Vaccine Intravesical |
|---|---|
| Sponsor | Nottingham University Hospitals NHS Trust |
| Drug class | Live attenuated vaccine / Immunotherapy |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BCG (Bacillus Calmette-Guerin) is a live attenuated mycobacterium that triggers a potent local immune response in the bladder urothelium. When instilled intravesically, it activates dendritic cells, macrophages, and T cells to target and eliminate bladder cancer cells, particularly non-muscle-invasive urothelial carcinoma. This immunotherapy approach reduces recurrence and progression of bladder cancer.
Approved indications
- Non-muscle-invasive bladder cancer (NMIBC), high-grade urothelial carcinoma
- Bladder cancer recurrence prevention
Common side effects
- Dysuria
- Urinary frequency
- Hematuria
- Fever
- Malaise
- BCG sepsis (rare)
Key clinical trials
- S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (PHASE3)
- A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer (PHASE1, PHASE2)
- A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) (PHASE3)
- Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer (PHASE4)
- Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (PHASE1, PHASE2)
- A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy (PHASE1, PHASE2)
- BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants (PHASE3)
- Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bacillus Calmette-Guerin Vaccine Intravesical CI brief — competitive landscape report
- Bacillus Calmette-Guerin Vaccine Intravesical updates RSS · CI watch RSS
- Nottingham University Hospitals NHS Trust portfolio CI
Frequently asked questions about Bacillus Calmette-Guerin Vaccine Intravesical
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Related
- Drug class: All Live attenuated vaccine / Immunotherapy drugs
- Manufacturer: Nottingham University Hospitals NHS Trust — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-muscle-invasive bladder cancer (NMIBC), high-grade urothelial carcinoma
- Indication: Drugs for Bladder cancer recurrence prevention
- Compare: Bacillus Calmette-Guerin Vaccine Intravesical vs similar drugs
- Pricing: Bacillus Calmette-Guerin Vaccine Intravesical cost, discount & access