Study Detail

« Back to Search Results Notify Me When Search is Updated

A clinical study of ifinatamab deruxtecan (I-DXd) in people with metastatic prostate cancer (MK-2400-001)

ClinicalTrials.gov Identifier: NCT06925737 (view full study on clinicaltrials.gov)
Condition:  Prostate Cancer, Prostatic Neoplasms
Status:  Recruiting


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

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,

Study Type:
Interventional
Study Phase:
Phase 3
Estimated Enrollment:
1440
Study Start Date:
May 2025
Estimated Study Completion Date:
January 2031
Estimated Primary Completion Date:
June 2028
Ages Eligible for Study:
18 years and older
Genders Eligible for Study:
Male
Accepts Healthy Volunteers:
No


CRITERIA

Inclusion Criteria:

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

Exclusion Criteria:

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

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
  • Has uncontrolled or significant cardiovascular disease
  • Has received prior treatment with a taxane-based chemotherapy agent for mCRPC

United States     Toll Free Number     1-800-770-4674   

  • Grand Rapids, Michigan, 49503
  • Billings, Montana, 59102
  • Roanoke, Virginia, 24014

No Study Results Posted



Find a Study in US or Canada

Advanced Search    Search All Studies

RELATED INFORMATION



Copyright © 2025 · Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved. · This site is intended only for residents of the United States.
Cookie Preferences  Privacy  Terms of Use  Consumer Health Data Privacy Policy  Your Privacy Choices   Accessibility  U.S. Corporate Site

Accessibility icon