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

a study on Prostate Cancer Metastatic Castration-Resistant Prostate Cancer

Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
study ends around

Description

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,

Official Title

A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

Keywords

Prostate Cancer, Prostatic Neoplasms, Docetaxel, Prednisone, Prednisolone, prednisolone acetate, Ifinatamab deruxtecan, I-DXd

Eligibility

You can join if…

Open to males ages 18 years and up

The main inclusion criteria include but are not limited to the following:

  • Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
  • Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
  • Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment

You CAN'T join if...

The main exclusion criteria include but are not limited to the following:

Locations

  • UCLA Hematology/Oncology - Santa Monica ( Site 0002) accepting new patients
    Los Angeles California 90404 United States
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006) accepting new patients
    Orange California 92868 United States
  • Moores Cancer Center ( Site 0010) accepting new patients
    La Jolla California 92093 United States
  • Cedars-Sinai Medical Center ( Site 0068) accepting new patients
    Los Angeles California 90048 United States
  • City of Hope Lennar Foundation Cancer Center ( Site 0059) accepting new patients
    Irvine California 92618 United States
  • City of Hope Comprehensive Cancer Center ( Site 0049) accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information
ID
NCT06925737
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1440 study participants
Last Updated
Contact us about this trial