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NCT05951179 (TARA002 in refractory/relapsed NMIBC): BVCT ex-ante prediction vs. reported outcome

On 19 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 23 Feb 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05951179
Acronym
ADVANCED-2
Drug Name
TARA002
Drug MoA
cell therapy that produces a pro-inflammatory response
Drug Modality
cell therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
refractory/relapsed NMIBC
Human Patients
131
Sponsor
Protara Therapeutics
Phase
Phase 2

Prediction of , index 1758

Prospective Prediction
Prediction Index
1758
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in CR/PFS/OS inferior to cretostimogene that's further inferior to TAR-200 that's further inferior to pembrolizumab)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit in CR against placebo in both 1L and 2L clinical settings)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
553 days in advance
Readout Data Interpretation
TARA002 achieved 43% CR at month 3 (3/7) and 68% CR at month 6 (15/22) for BCG-unresponsive patients, inferior to pembrolizumab's 89% CRR at month 3 and inferior to pembrolizumab's 77% CR at month 6 for BCG-unresponsive patients (https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00147-9/abstract KEYNOTE-057)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer
Phase
Phase 2
Status
Recruiting
Enrollment
131
Lead sponsor
Protara Therapeutics
Conditions
Non-muscle Invasive Bladder Cancer
Interventions
BIOLOGICAL: TARA-002
Design
Single group · None
Primary purpose
Treatment
Start
2023-09-15
Primary completion
2031-10
Completion
2032-03
Primary outcomes
  • Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002 (Month 3 to Month 60)

NCT05951179 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials