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Vicinium

Phase 3

Bladder Cancer | Monoclonal antibody | Oncology |Carisma Therapeutics, Inc.|Last Updated: Jul 24, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment133
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02449239Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCGPHASE3 COMPLETED 133Aug 1, 2015May 1, 2022Jul 24, 202370 United States, Canada
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Study Endpoints
Primary Endpoints
Complete Response Rate at 3 Months
3 months from start of treatment

Complete response rate at 3 months in patients with CIS with or without resected papillary disease following initiation of Vicinium therapy. This is the percentage of patients who were free of high-grade disease at the post-induction (3 month) assessment timepoint. A patient was considered to have a complete response if the urine cytology was reported as negative or atypical AND the cystoscopy was reported as normal or any suspicious areas were deemed negative for high-grade disease upon biopsy assessment.

Duration of Complete Response
Up to 24 months

Duration of complete response in participants with CIS with or without resected papillary disease who achieved a complete response at the post-induction (3 month) assessment. This is the number of days from the date of first occurrence of complete response to the date of documented treatment failure or death, whichever occurs first

Secondary Endpoints
Event-free Survival
Up to 24 months
Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months
Participants on treatment were assessed at months 6, 9, 12, 15,18, 21, and 24
Time to Cystectomy
Up to 48 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ViciniumEXPERIMENTALInduction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks. Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Interventions
NameTypeDescription
ViciniumBIOLOGICALIntravesical administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites70

Inclusion Criteria: 1. Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder as follows: 1. CIS (with or without papillary disease) OR 2. Any grade T1 papillary disease OR 3. High-grade Ta papillary disease based on a biopsy within ...

Countries:United StatesCanada
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Competitive Landscape -Bladder Cancer 147 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN15PHASE3Durvalumab, Bacillus Calmette-Guerin, Tremelimumab, Enfortumab Vedotin, Cisplatin
Bristol-Myers Squibb CompanyBMY5PHASE3Nivolumab, Gemcitabine, Cisplatin, Ipilimumab, Carboplatin
Johnson & JohnsonJNJ13PHASE3TAR-200, Mitomycin C, Gemcitabine, Cetrelimab, BCG Vesiculture
Merck & Co., Inc.MRK13PHASE3Pembrolizumab, BCG, Cisplatin, Fluorouracil, Mitomycin C
Pfizer Inc.PFE10PHASE3PF-06801591, Bacillus Calmette-Guerin, Avelumab, Lorlatanib, Talazoparib
Eli Lilly and CompanyLLY4PHASE3Vepugratinib, EV, Pembrolizumab, LY4101174, LY4052031
UroGen Pharma Ltd.URGN4PHASE3UGN-103, UGN-102, UGN-104, Jelmyto for pyelocalyceal
Natera, Inc.NTRA2PHASE3Atezolizumab
CG Oncology, Inc.CGON2PHASE3Cretostimogene Grenadenorepvec
Protara Therapeutics, Inc.TARA2PHASE3TARA-002
Relmada Therapeutics IncRLMD2PHASE3NDV-01, NDV01 intravesical controlled release formulation of gemcitabine and docetaxel
ImmunityBio IncIBRX6PHASE2N-803 and BCG, N-803 + Pembrolizumab, BCG + N-803, Intravesical Recombinant Mycobacterium, N803 plus Bacillus Calmette-Guerin
BeOne Medicines Ltd. Sponsored ADRONC3PHASE3Tislelizumab, Cisplatin, Gemcitabine, Carboplatin, BGB-A445
Exelixis, Inc.EXEL4PHASE2Cabozantinib, Atezolizumab, Zanzalintinib, cabozantinib, atezolizumab
Gilead Sciences, Inc.GILD2PHASE2Sacituzumab Govitecan-hziy, Pembrolizumab, Cisplatin, Avelumab, Zimberelimab
Tyra Bioscience, IncTYRA3PHASE2Dabogratinib, Dabogratinib TBD, TYRA-300, TYRA-300 Dose TBD
BioNTech SE Sponsored ADRBNTX1PHASE2Autogene Cevumeran, Nivolumab, Saline
ICON PlcICLR1PHASE3padeliporfin VTP
AbbVie, Inc.ABBV1PHASE2Livmoniplimab, Budigalimab, Docetaxel, Paclitaxel, Gemcitabine
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
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