Drugs / Bacillus Calmette-Guérin
Bacillus Calmette-Guérin
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03175380 | Aug 2017 → Jan 2019 | tuberculosis | Aeras | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT01838200 | Mar 2014 → Aug 2015 | metastatic melanoma | Ludwig Institute for Cancer Research | Terminated | No outcome recorded Stop: Enrollment |
| Phase 26 trials | ||||||
| Phase 2 | NCT07307456 | Dec 2025 → Dec 2027 expected | urinary bladder cancer | Changhai Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05866536 | May 2023 → May 2031 expected | type 1 diabetes mellitus | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05004688 | Mar 2022 → Jan 2024 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Steven E Arnold, MD | Completed | No outcome recorded |
| Phase 2 | NCT05180591 | Mar 2022 → Mar 2031 expected | diabetes mellitus, congenital autoimmune, type 1 diabetes mellitus | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02081326 | Jun 2015 → Jul 2029 expected | COVID-19, latent autoimmune diabetes in adults | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02281383 | Oct 2014 → Feb 2022 | urinary bladder cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03928275 | Dec 2021 → Sep 2022 | metastatic melanoma | Carman Giacomantonio | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT00330707 | Oct 1995 → Jun 2005 | superficial urinary bladder carcinoma | National University Hospital, Singapore | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT06441110 | Jun 2023 → Jun 2025 overdue | urinary bladder neoplasm | Fujian Medical University Union Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05538663 | Feb 2023 → Nov 2029 expected | urinary bladder carcinoma | ECOG-ACRIN Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04165317 | Dec 2019 → Dec 2024 overdue | urinary bladder carcinoma | Pfizer | Active not recruiting | Met primary |
| Phase 3 | NCT03528694 | May 2018 → Apr 2025 overdue | non-invasive bladder urothelial carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT02795260 | May → Oct 2016 | tuberculosis | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00974818 | Sep 2009 → Mar 2012 | urinary bladder cancer | Memorial Sloan Kettering Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 42 trials | ||||||
| Phase 4 | NCT05701332 | Apr 2023 → Dec 2025 | oligospermia, urothelial carcinoma | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT04701151 | Feb 2021 → Dec 2026 expected | — | Jørgen Bjerggaard Jensen | Active not recruiting | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06324058 | Mar 2024 → Mar 2025 | urinary bladder cancer | Huashan Hospital | Unknown | No outcome recorded |
| — | NCT03246230 | Sep 2017 → Aug 2022 | — | Boston Children's Hospital | Completed | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1/2 | NCT04179162 Background | Nov 2019 → Nov 2027 expected | non-invasive bladder urothelial carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT00671554 Background | Apr 2008 → Feb 2009 | melanoma | Prisma Health-Upstate | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT06636682 Background | Oct 2024 → Feb 2027 expected | prostate adenocarcinoma | Cellvax Therapeutics Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT03504163 Background | Jun 2018 → Apr 2027 expected | urinary bladder cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07726992 Background | Aug 2026 → Dec 2029 expected | non-invasive bladder papillary urothelial neoplasm | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07207824 Comparator | Dec 2025 → Jun 2030 expected | non-invasive bladder urothelial carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04806178 Comparator | Sep 2021 → May 2024 | urinary bladder cancer | University of Campinas, Brazil | Completed | No outcome recorded |
| Phase 3 | NCT06462001 Background | Dec 2020 → Dec 2026 expected | transitional cell carcinoma | Nottingham University Hospitals NHS Trust | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01284205 Comparator | Jan 2010 → Feb 2014 | urinary bladder cancer | Bioniche Life Sciences Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT00384891 Comparator | Feb 2002 → Dec 2013 | urinary bladder cancer | Medical Enterprises Europe B.V. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01442519 Comparator | Jan 1994 → Jun 2002 | urinary bladder cancer | University of Rome Tor Vergata | Completed | Met primary |
| Phase 3 | NCT02254915 Comparator | ? → Jan 2020 | urinary bladder neoplasm | Medical Enterprises Europe B.V. | Withdrawn | No outcome recorded |
| Phase 4 | NCT03790384 Background | Jan → Sep 2019 | urinary bladder cancer | Azienda Ospedaliera "Sant'Andrea" | Unknown | Missed primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-05-28 | AstraZeneca | Regulatory Imfinzi approved in the US in first and only immunotherapy combination for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer. astrazeneca.com ↗
AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the US for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). |
| 2025-10-17 | AstraZeneca | Results Imfinzi regimen reduced the risk of disease recurrence or death by 32% in high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial astrazeneca.com ↗
Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone |
| 2025-05-09 | AstraZeneca | Results Imfinzi regimen demonstrated statistically significant and clinically meaningful improvement in disease-free survival for high-risk non-muscle-invasive bladder cancer in POTOMAC Phase III trial astrazeneca.com ↗ |
| 2025-04-26 | Pfizer | Results Pfizer’s Sasanlimab Combination Significantly Improves Event-Free Survival in BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer pfizer.com ↗ |
| 2025-01-10 | Pfizer | Results Pfizer’s Sasanlimab in Combination with BCG Improves Event-Free Survival in Patients with BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer pfizer.com ↗
The study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance). |
All press releases naming this drug 6 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bacillus Calmette-Guérin | “This study aims to evaluate the efficacy and safety of toripalimab (a PD-1 inhibitor) combined with Bacillus Calmette-Guérin (BCG) intravesical instillation as adjuvant therapy...” NCT07307456 ↗34“Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer” NCT07207824 ↗ “A separate injection of Bacillus Calmette-Guerin (BCG) is administered in the same area within 10 minutes of the dendritoma injection.” NCT00671554 ↗ “The immune adjuvant Bacillus Calmette Guérin (BCG) will be given concurrently with Dose 1 (day 1) and Dose 2 (day 8).” NCT06636682 ↗ “Bacillus Calmette-Guerin instillation of bladder after surgery according to the NCCN bladder cancer guidelines.” NCT06324058 ↗ “Bacillus Calmette-Guérin vaccine (BCG)” NCT04701151 ↗ “Bacillus Calmette-Guérin (BCG)” PMID 38842053 ↗ Jun 2024 “Bacillus Calmette Guerin (BCG)” NCT07726992 ↗ “Bacillus Calmette-Guerin” NCT03790384 ↗ |
| Known as | BCG | “This study aims to evaluate the efficacy and safety of toripalimab (a PD-1 inhibitor) combined with Bacillus Calmette-Guérin (BCG) intravesical instillation as adjuvant therapy...” NCT07307456 ↗17“A separate injection of Bacillus Calmette-Guerin (BCG) is administered in the same area within 10 minutes of the dendritoma injection.” NCT00671554 ↗ “The immune adjuvant Bacillus Calmette Guérin (BCG) will be given concurrently with Dose 1 (day 1) and Dose 2 (day 8).” NCT06636682 ↗ “postresection intravesical BCG (81 mg [n=50] or 27 mg [n=19]) or BCG (27 mg) with interferon alpha (IFN-α; n=30).” PMID 21163569 ↗ Dec 2010 “Licensed BCG vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.” NCT03246230 ↗ “BCG (Oncotice) is administered intravesically as per usual standard of care” NCT06462001 ↗ “Bacillus Calmette-Guérin (BCG) induction and maintenance” PMID 40450141 ↗ May 2025 “multi-dose Bacillus Calmette-Guérin (BCG) vaccine” PMID 36027906 ↗ Aug 2022 “with ImmuCyst (81 mg Connaught strain BCG)” NCT03790384 ↗ “Bacillus Calmette-Guérin vaccine (BCG)” NCT04701151 ↗ “Bacillus Calmette-Guerin (BCG)” NCT03528694 ↗ |
| Known as | ImmuCyst | “with ImmuCyst (81 mg Connaught strain BCG)” NCT03790384 ↗ |
| Known as | Japan BCG | “Two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart.” NCT05004688 ↗ |
| Known as | Oncotice | “BCG (OncoTICE solutions 1-8 x 10-8 Colony Forming Units (CFU)) will be administered at a maximum dose of 3.2 million CFU per treatment at a maximum of 1.6 million CFU per...” NCT03928275 ↗1“BCG (Oncotice) is administered intravesically as per usual standard of care” NCT06462001 ↗ |
| Modality | Vaccine | “Bacillus Calmette-Guérin (BCG) vaccine” NCT01838200 ↗ |
| Route | Subcutaneous | “Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG.” NCT00671554 ↗ |