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NCT04527991 (Sacituzumab Govitecan-hziy Paclitaxel Docetaxel… in Metastatic or Locally Advanced Unresectable Urothelial…): BVCT ex-ante prediction vs. reported outcome

On 5 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 30 May 2024 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient (non-superior).

Clinical Trial

NCTID
NCT04527991
Acronym
TROPiCS-04
Drug Name
Sacituzumab Govitecan-hziy Paclitaxel Docetaxel Vinflunine
Drug MoA
anti-TROP2 ADC with SN38 payload for lysosomal-degradation-mediated intracellular release
Drug Modality
ADC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic or Locally Advanced Unresectable Urothelial Cancer
Human Patients
696
Sponsor
Gilead Sciences
Phase
Phase 3

Prediction of , index 1495

Prospective Prediction
Prediction Index
1495
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit with superior-to-chemotherapy efficacy in OS)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
86 days in advance
Readout Data Interpretation
OS primary endpoint not met.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal drug MoA modeling that has been permanently corrected.
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient (non-superior)
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer
Phase
Phase 3
Status
Completed
Enrollment
711
Lead sponsor
Gilead Sciences
Conditions
Locally Advanced or Metastatic Unresectable Urothelial Cancer
Interventions
DRUG: Sacituzumab Govitecan-hziy; DRUG: Paclitaxel; DRUG: Docetaxel; DRUG: Vinflunine
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-01-13
Primary completion
2025-07-04
Completion
2025-07-04
Results first posted
2026-06-02
Primary outcomes
  • Overall Survival (OS) (Up to 42 months)

NCT04527991 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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