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NCT03922204 (MCLA-145 in Advanced or Metastatic Malignancies): BVCT ex-ante prediction vs. reported outcome

On 16 Jun 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 23 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and partially commercially sufficient (ORR is superior to pembrolizumab monotherapy).

Clinical Trial

NCTID
NCT03922204
Drug Name
MCLA-145
Drug MoA
anti-PD-L1 and anti-CD137 bispecific antibody
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced or Metastatic Malignancies
Human Patients
118
Sponsor
Merus
Phase
Phase 1

Prediction of , index 977

Prospective Prediction
Prediction Index
977
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit anti-PD1 mono clinical efficacy)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
342 days in advance
Readout Data Interpretation
9.6% ORR for mono and 10.5% ORR for combo.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and partially commercially sufficient (ORR is superior to pembrolizumab monotherapy)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1, Open-Label, Dose-Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MCLA-145 in Participants With Advanced or Metastatic Malignancies
Phase
Phase 1
Status
Completed
Enrollment
72
Lead sponsor
Merus B.V.
Conditions
Advanced Cancer; Solid Tumor, Adult; B-cell Lymphoma, Adult
Interventions
DRUG: MCLA-145; DRUG: Pembrolizumab (Keytruda)
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2019-05-08
Primary completion
2024-11-07
Completion
2024-11-07
Primary outcomes
  • Number of patients with Dose Limiting Toxicities (first 28 days of treatment)
  • Number of patients with Adverse Events and Serious Adverse Events (up to 90 days post-last dose)

NCT03922204 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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