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BCG Solution
BCG (Bacillus Calmette-Guérin) is a live attenuated mycobacterium that stimulates the immune system to recognize and destroy cancer cells, particularly in the bladder.
BCG (Bacillus Calmette-Guérin) is a live attenuated mycobacterium that stimulates the immune system to recognize and destroy cancer cells, particularly in the bladder. Used for Non-muscle-invasive bladder cancer (NMIBC), including carcinoma in situ (CIS), High-grade urothelial carcinoma of the bladder.
At a glance
| Generic name | BCG Solution |
|---|---|
| Also known as | Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution, Experimental GROUP |
| Sponsor | Alliance for Clinical Trials in Oncology |
| Drug class | Live attenuated vaccine / Immunotherapy |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
BCG works as an immunotherapy by activating innate and adaptive immune responses against tumor cells. When instilled directly into the bladder, it triggers local inflammation and recruits immune cells (T cells, macrophages, dendritic cells) that recognize and eliminate malignant urothelial cells. This mechanism has made BCG the gold standard for non-muscle-invasive bladder cancer treatment for decades.
Approved indications
- Non-muscle-invasive bladder cancer (NMIBC), including carcinoma in situ (CIS)
- High-grade urothelial carcinoma of the bladder
Common side effects
- Dysuria (painful urination)
- Urinary frequency
- Hematuria (blood in urine)
- Fever
- Malaise
- BCG sepsis (rare but serious)
Key clinical trials
- Early vs Delayed Intravesical Blad-Care During BCG Therapy (NA)
- S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (PHASE3)
- Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (PHASE1, PHASE2)
- Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer (PHASE4)
- 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)
- Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers (PHASE1)
- Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients (NA)
- Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer (PHASE2)
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 |