BioinvestGPT

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NCT03937219 (Cabozantinib in Renal Cell Carcinoma): BVCT ex-ante prediction vs. reported outcome

On 31 Oct 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 24 Aug 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT03937219
Acronym
COSMIC-313
Drug Name
Cabozantinib
Drug MoA
RTK inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Renal Cell Carcinoma
Human Patients
855
Sponsor
Exelixis
Phase
Phase 3

Prediction of , index 1304

Prospective Prediction
Prediction Index
1304
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
298 days in advance
Readout Data Interpretation
cabozantinib failed to achieve additive clinical benefit in OS
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk
Phase
Phase 3
Status
Active not recruiting
Enrollment
855
Lead sponsor
Exelixis
Conditions
Renal Cell Carcinoma
Interventions
DRUG: Cabozantinib; BIOLOGICAL: Nivolumab; BIOLOGICAL: Ipilimumab; DRUG: Cabozantinib-matched placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2019-06-25
Primary completion
2022-01-31
Completion
2027-01-31
Results first posted
2025-09-10
Primary outcomes
  • Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC) (Up to 32 months)

NCT03937219 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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