A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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
Qualifiers
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
Disqualifiers
Is unable to swallow tablets/capsules
Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
Has current ILD/pneumonitis
Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
Trial design
Treatments tested in this trial
- Ifinatamab deruxtecan
- Docetaxel
- Prednisone
- Rescue Medication
Treatment groups
1,440 Participants
are divided into 2 treatment groupsSponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
Daiichi Sankyo
Collaborator
Source ClinicalTrials.gov