Drugs / Bacillus Calmette-Guérin
last change Mar 2026 re-read 2 minutes ago

Bacillus Calmette-Guérin

also known as BCG · OncoTICE · ImmuCyst · Japan BCG

Vaccine

Developed for
urinary bladder cancer · metastatic melanoma · tuberculosis · type 1 diabetes mellitus · urinary bladder carcinoma · Alzheimer disease · cognitive impairment with or without cerebellar ataxia · COVID-19
+6 more · diabetes mellitus, congenital autoimmune · latent autoimmune diabetes in adults · non-invasive bladder urothelial carcinoma · superficial urinary bladder carcinoma · urinary bladder neoplasm · urothelial carcinoma
Investigated by
Massachusetts General Hospital · Memorial Sloan Kettering Cancer Center · Aalborg University Hospital · Aarhus University Hospital · Aeras · Air Force Military Medical University, China
+36 more · Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Assiut University · AstraZeneca · Boston Children's Hospital · Bristol-Myers Squibb · Carman Giacomantonio · Changhai Hospital · ECOG-ACRIN Cancer Research Group · Fujian Medical University Union Hospital · Herlev Hospital · Huashan Hospital · Institute for Medical Research, Papua New Guinea · Jiangsu Province Centers for Disease Control and Prevention · Jurong Centers for Disease Control and Prevention · Jørgen Bjerggaard Jensen · Karolinska University Hospital · Landspitali University Hospital · Ludwig Institute for Cancer Research · Medical Research Council Unit, The Gambia · National Cancer Institute (NCI) · National Medical Research Council (NMRC), Singapore · National University Hospital, Singapore · New York Presbyterian Hospital · Nova Scotia Health Authority · Odense University Hospital · Pfizer · Proswell Medical Corporation · Region Örebro County · Regional Hospital West Jutland · Rigshospitalet, Denmark · Sahlgrenska University Hospital · Steven E Arnold, MD · The University of Western Australia · University of British Columbia · Weill Medical College of Cornell University · Zealand University Hospital

Trials 20 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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
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
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 No outcome recorded
Phase 3 NCT03528694 May 2018 → Apr 2025 overdue non-invasive bladder urothelial carcinoma AstraZeneca Active not recruiting No outcome recorded
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
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
Also used as a comparator or background therapy in 12 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/22 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
Phase 22 trials
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 37 trials
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
Phase 41 trial
Phase 4 NCT03790384 Background Jan → Sep 2019 urinary bladder cancer Azienda Ospedaliera "Sant'Andrea" Unknown No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 36 sources stand behind the page.

FieldValueCited text
Known as Bacillus Calmette-Guerin “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
33

“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-GuerinNCT03790384

NCT05866536

NCT06441110

NCT02281383

NCT03504163

NCT04806178

NCT02795260

NCT03928275

NCT04179162

NCT05180591

NCT00384891

NCT03175380

NCT04165317

NCT04701151

NCT00330707

NCT05004688

NCT02081326

NCT05538663

NCT03246230

NCT00974818

NCT01838200

NCT01442519

NCT06462001

NCT03528694

NCT02254915

NCT05701332

NCT01284205

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
16

“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-Guérin (BCG)” NCT03504163

“Bacillus Calmette-Guerin (BCG)” NCT00974818

“Bacillus Calmette-Guérin (BCG)” NCT02281383

“Bacillus Calmette-Guerin (BCG)” NCT03528694

“Bacillus Calmette-Guérin (BCG)” NCT04179162

BCGNCT03175380

BCGNCT04806178

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) vaccineNCT01838200
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