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NCT03674567 (FLX475 Pembrolizumab in Advanced Cancer): BVCT ex-ante prediction vs. reported outcome

On 10 Aug 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 10 Apr 2024 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
NCT03674567
Drug Name
FLX475 Pembrolizumab
Drug MoA
CCR4 antagonist
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Cancer
Human Patients
323
Sponsor
RAPT Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1211

Prospective Prediction
Prediction Index
1211
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
244 days in advance
Readout Data Interpretation
15.6% ORR (vs 27.3% ORR by pembrolizumab alone as 2L for advanced HNSCC in KEYNOTE-048.
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
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
323
Lead sponsor
RAPT Therapeutics, Inc., a member of the GSK plc group of companies
Conditions
Advanced Cancer
Interventions
DRUG: FLX475 (tivumecirnon); DRUG: pembrolizumab (KEYTRUDA®)
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2018-09-25
Primary completion
2024-12-31
Completion
2024-12-31
Results first posted
2026-09-03
Primary outcomes
  • Safety and Tolerability of FLX475 as a Single Agent and in Combination With Pembrolizumab Measured by the Incidence of Adverse Events, Including Dose-limiting Toxicities and Maximum Tolerated Dose (Approximately 18 weeks)
  • Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab (Through study completion (approximately 2 years))

NCT03674567 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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