A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Merck Sharp & Dohme LLC
1,440 participants
May 13, 2025
INTERVENTIONAL
Conditions
Summary
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Oral tablet administered once per day or per approved product label
Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label
Locations(281)
View Full Details on ClinicalTrials.gov
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NCT06925737