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NCT05907954 (Darovasertib in Localized Ocular Melanoma): BVCT ex-ante prediction vs. reported outcome

On 18 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 3 Jun 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (no neoadjuvant SoC established for ocular melanoma).

Clinical Trial

NCTID
NCT05907954
Acronym
NADOM
Drug Name
Darovasertib
Drug MoA
potent selective oral PKC inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Localized Ocular Melanoma
Human Patients
82
Sponsor
IDEAYA Biosciences
Phase
Phase 2

Prediction of , index 1334

Prospective Prediction
Prediction Index
1334
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
77 days in advance
Readout Data Interpretation
75% confirmed eye saved.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (no neoadjuvant SoC established for ocular melanoma)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Phase
Phase 2
Status
Active not recruiting
Enrollment
160
Lead sponsor
IDEAYA Biosciences
Conditions
Uveal Melanoma
Interventions
DRUG: Darovasertib
Design
Single group · None
Primary purpose
Treatment
Start
2023-07-03
Primary completion
2027-04-30
Completion
2030-04-30
Primary outcomes
  • Incidence of Adverse Events (AEs) and significant laboratory abnormalities (from first dose to 28 days after last dose of therapy, approximately 18 months)
  • Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation (from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months)
  • Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose (from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months)
  • Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria (from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months)

NCT05907954 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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