Health Trials

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

ConditionsProstate CancerProstatic Neoplasms
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 groups

Locations

290
Argentina
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)B1884BBF, BerazateguiBuenos Aires, Argentina
Instituto Alexander Fleming ( Site 0125)C1426ANZ, Mar del PlataBuenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0129)B7600FZO, Mar del PlataBuenos Aires, Argentina
Sanatorio Parque ( Site 0126)S2000DSV, RosarioSanta Fe Province, Argentina

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator

Source ClinicalTrials.gov