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NCT04609566 (Brentuximab Vedotin With Pembrolizumab in Melanoma Non-small Cell Lung Cancer Squamous…): BVCT ex-ante prediction vs. reported outcome

On 15 Jan 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 23 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially non-superior to SoC (chemo alone).

Clinical Trial

NCTID
NCT04609566
Drug Name
Brentuximab Vedotin With Pembrolizumab
Drug MoA
anti-CD30 ADC with MMAE as payload
Drug Modality
antibody-drug conjugate (ADC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Melanoma Non-small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck
Human Patients
140
Sponsor
Pfizer
Phase
Phase 2

Prediction of , index 1422

Prospective Prediction
Prediction Index
1422
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit with non-superior-to-SoC efficacy in ORR/PFS/OS)
Technical Prediction
partial SUCCESS (statistically significant yet weak additive clinical benefit to pembrolizumab more for melanoma than for NSCLC or HNSCC)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
129 days in advance
Readout Data Interpretation
13-21% ORR and 12.9-13.9 months OS and 17% TEAE discontinuation (vs 11.5-12 months OS for chemo alone or more for chemo+X).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially non-superior to SoC (chemo alone)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Participants With Metastatic Solid Malignancies
Phase
Phase 2
Status
Completed
Enrollment
161
Lead sponsor
Seagen, a wholly owned subsidiary of Pfizer
Conditions
Melanoma; Non-small Cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG: brentuximab vedotin; DRUG: pembrolizumab
Design
Parallel · None
Primary purpose
Treatment
Start
2021-01-26
Primary completion
2026-02-03
Completion
2026-02-03
Primary outcomes
  • Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria (Up to approximately 2 years)

NCT04609566 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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