{"id":"bacillus-calmette-guerin-strain-tice","safety":{"commonSideEffects":[{"rate":"40-60","effect":"Dysuria / urinary frequency"},{"rate":"20-40","effect":"Hematuria"},{"rate":"10-20","effect":"Fever"},{"rate":"10-15","effect":"Fatigue"},{"rate":"1-5","effect":"BCG infection / systemic toxicity"},{"rate":"30-50","effect":"Cystitis"}]},"_chembl":{"chemblId":"CHEMBL2108905","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCG (Bacillus Calmette-Guerin) TICE strain is an intracellular pathogen that activates dendritic cells, macrophages, and T cells through pattern recognition receptors, promoting a Th1-type immune response. When administered intravesically or systemically, it enhances both local and systemic anti-tumor immunity, particularly useful in bladder cancer and potentially other malignancies. The mechanism leverages the immunogenicity of the live attenuated mycobacterium to prime the immune system against tumor-associated antigens.","oneSentence":"BCG TICE is a live attenuated mycobacterial vaccine that stimulates innate and adaptive immune responses to enhance anti-tumor immunity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:06.102Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-muscle invasive bladder cancer (NMIBC)"},{"name":"Potentially other solid tumors (investigational)"}]},"trialDetails":[{"nctId":"NCT03091660","phase":"PHASE3","title":"S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"SWOG Cancer Research Network","startDate":"2017-02-24","conditions":"Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma","enrollment":1000},{"nctId":"NCT05037279","phase":"PHASE3","title":"Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)","status":"RECRUITING","sponsor":"Verity Pharmaceuticals Inc.","startDate":"2024-04-24","conditions":"Bladder Cancer, Bladder Cancer Recurrent, Neoplasm Recurrence","enrollment":540},{"nctId":"NCT06845358","phase":"PHASE1","title":"Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans","status":"WITHDRAWN","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2025-11-26","conditions":"Tuberculosis","enrollment":""},{"nctId":"NCT03504163","phase":"PHASE2","title":"Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2018-06-27","conditions":"Bladder Cancer","enrollment":45},{"nctId":"NCT07064863","phase":"PHASE1, PHASE2","title":"A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.","status":"NOT_YET_RECRUITING","sponsor":"Queen's University","startDate":"2025-08-01","conditions":"NMIBC, Non-Muscle Invasive Bladder Urothelial Carcinoma, Bladder (Urothelial, Transitional Cell) Cancer","enrollment":31},{"nctId":"NCT02015104","phase":"PHASE2","title":"Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2013-12-18","conditions":"Bladder Cancer","enrollment":32},{"nctId":"NCT04179162","phase":"PHASE1, PHASE2","title":"Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2019-11-22","conditions":"Non-Muscle Invasive Bladder Cancer (NMIBC)","enrollment":54},{"nctId":"NCT04348370","phase":"PHASE4","title":"BCG Vaccine for Health Care Workers as Defense Against COVID 19","status":"COMPLETED","sponsor":"Texas A&M University","startDate":"2020-04-20","conditions":"Coronavirus, Coronavirus Infection, Coronavirus as the Cause of Diseases Classified Elsewhere","enrollment":659},{"nctId":"NCT03928275","phase":"PHASE2, PHASE3","title":"The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma","status":"WITHDRAWN","sponsor":"Carman Giacomantonio","startDate":"2021-12-01","conditions":"Cutaneous Metastatic Melanoma","enrollment":""},{"nctId":"NCT00070070","phase":"PHASE1","title":"Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas","status":"COMPLETED","sponsor":"Ludwig Institute for Cancer Research","startDate":"2003-10-28","conditions":"Transitional Cell Carcinoma","enrollment":6},{"nctId":"NCT04449926","phase":"PHASE2","title":"BCG and Plasma Amyloid in Non-Demented Adults","status":"COMPLETED","sponsor":"Mindful Diagnostics and Therapeutics, LLC","startDate":"2020-11-09","conditions":"Alzheimer Disease, Late Onset","enrollment":49},{"nctId":"NCT04632537","phase":"PHASE3","title":"BCG Vaccination to Prevent COVID-19","status":"WITHDRAWN","sponsor":"Henry M. Jackson Foundation for the Advancement of Military Medicine","startDate":"2020-12-07","conditions":"COVID-19","enrollment":""},{"nctId":"NCT01868464","phase":"PHASE1","title":"Challenge Model for Assessment of Human TB Immunity","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2014-05-28","conditions":"Tuberculosis","enrollment":92},{"nctId":"NCT02088892","phase":"NA","title":"A Clinical Challenge Study of BCG in Healthy Volunteers","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2014-03","conditions":"Tuberculosis","enrollment":52},{"nctId":"NCT00696579","phase":"PHASE1, PHASE2","title":"Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer","status":"COMPLETED","sponsor":"University Of Perugia","startDate":"2004-01","conditions":"Bladder Cancer","enrollment":64}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":101,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["OncoTICE"],"phase":"phase_3","status":"active","brandName":"Bacillus Calmette-Guerin: Strain TICE","genericName":"Bacillus Calmette-Guerin: Strain TICE","companyName":"Verity Pharmaceuticals Inc.","companyId":"verity-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BCG TICE is a live attenuated mycobacterial vaccine that stimulates innate and adaptive immune responses to enhance anti-tumor immunity. Used for Non-muscle invasive bladder cancer (NMIBC), Potentially other solid tumors (investigational).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}