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NCT04387461 (CG0070 Pembrolizumab Injection n-dodecyl-B-D-maltoside in Non-Muscle Invasive Bladder Cancer): BVCT ex-ante prediction vs. reported outcome

On 15 Apr 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 24 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT04387461
Acronym
CORE-001
Drug Name
CG0070 Pembrolizumab Injection n-dodecyl-B-D-maltoside
Drug MoA
oncolytic adenovirus genetically engineered with an E2F1 promoter region to replicate only in Rb-defective cells and a GM-CSF transgene
Drug Modality
oncolytic virus therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Non-Muscle Invasive Bladder Cancer
Human Patients
35
Sponsor
CG Oncology
Phase
Phase 2

Prediction of , index 1542

Prospective Prediction
Prediction Index
1542
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit with superior-to-pembrolizumab-monotherapy efficacy in CR/PFS/OS)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
405 days in advance
Readout Data Interpretation
54% CR (vs 42% CR for pembrolizumab alone).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
Phase
Phase 2
Status
Completed
Enrollment
35
Lead sponsor
CG Oncology, Inc.
Conditions
Non Muscle Invasive Bladder Cancer
Interventions
BIOLOGICAL: CG0070; BIOLOGICAL: Pembrolizumab Injection; OTHER: n-dodecyl-B-D-maltoside
Design
Single group · None
Primary purpose
Treatment
Start
2020-12-08
Primary completion
2023-03-07
Completion
2024-05-28
Primary outcomes
  • Complete response rate in patients (12 months)

NCT04387461 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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