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NCT03602859 (Dostarlimab in 1L combotherapy treatment for advanced ovarian…): BVCT ex-ante prediction vs. reported outcome

On 15 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 20 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (PFS) and commercially insufficient (OS).

Clinical Trial

NCTID
NCT03602859
Acronym
FIRST
Drug Name
Dostarlimab (TSR-042)
Drug MoA
anti-PD1 mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
1L combotherapy treatment for advanced ovarian cancer
Human Patients
1402
Sponsor
GSK
Phase
Phase 3

Prediction of , index 1390

Prospective Prediction
Prediction Index
1390
Prediction Date
Commercial Prediction
FAILURE (commercially maybe sufficient yet very weak additive clinical benefit in OS)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
127 days in advance
Readout Data Interpretation
dostarlimab + SoC + niraparib +/ bevacizumab achieved statistical significance in PFS yet failed to achieve statistical significance in OS; compared with SoC + niraparib +/ bevacizumab
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (PFS) and commercially insufficient (OS)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
Phase
Phase 3
Status
Active not recruiting
Enrollment
1400
Lead sponsor
Tesaro, Inc.
Conditions
Ovarian Neoplasms; Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Interventions
DRUG: Niraparib; DRUG: Dostarlimab (TSR-042); DRUG: Standard of care; DRUG: Dostarlimab-Placebo; DRUG: Niraparib-Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2018-10-11
Primary completion
2024-10-31
Completion
2029-04-30
Results first posted
2025-12-31
Primary outcomes
  • Progression Free Survival (PFS) (Up to approximately 316 weeks)

NCT03602859 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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