BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05568095 (Domvanalimab in First-Line Upper GI Cancers): BVCT ex-ante prediction vs. reported outcome

On 18 Jun 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 12 Dec 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05568095
Acronym
STAR-221
Drug Name
Domvanalimab
Drug MoA
anti-TIGIT
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
First-Line Upper GI Cancers (Gastric/Esophageal)
Human Patients
1040
Sponsor
Arcus Biosciences
Phase
Phase 3

Prediction of , index 512

Prospective Prediction
Prediction Index
512
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
908 days in advance
Readout Data Interpretation
domvanalimab + zimberelimab + chemotherapy was deemed unlikely to achieve superior clinical benefit OS compared with nivolumab + chemotherapy and was discontinued due to futility
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma
Phase
Phase 3
Status
Completed
Enrollment
1040
Lead sponsor
Arcus Biosciences, Inc.
Conditions
Advanced Upper Gastrointestinal Tract Adenocarcinoma
Interventions
DRUG: Domvanalimab; DRUG: Zimberelimab; DRUG: Capecitabine; DRUG: Fluorouracil; DRUG: Leucovorin; DRUG: Oxaliplatin; DRUG: Nivolumab
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-11-21
Primary completion
2026-08-28
Completion
2026-08-28
Primary outcomes
  • Overall survival (From date of randomization until date of death from any cause (Approximately 15 months)])

NCT05568095 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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