Trial Filter
BETAAn intelligent search tool for clinical trials
Official Title
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Phase
Phase 3
Sponsor
Merck Sharp & Dohme LLC
Enrollment
1,440
Timeline
May 2025 → Jan 2031
About This Study
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 Criteria
Inclusion Criteria
- 1Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
- 2Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
- 3Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment
Exclusion Criteria
- 1History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
- 2Has uncontrolled or significant cardiovascular disease
- 3Has received prior treatment with a taxane-based chemotherapy agent for mCRPC
Locations
249 sites participating in this study
Emory University School of Medicine- Grady Campus ( Site 0103)
Atlanta, Georgia 30303
Study Coordinator
Winship Cancer Institute, Emory University ( Site 0003)
Atlanta, Georgia 30322
Study Coordinator
Mayo Clinic in Arizona - Phoenix ( Site 0044)
Phoenix, Arizona 85054
Study Coordinator
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →