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

Description

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,

Conditions

Prostate Cancer, Prostatic Neoplasms

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Study Overview

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Study Details

Study overview

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,

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

Cancer and Hematology Centers of Western Michigan ( Site 0015), Grand Rapids, Michigan, United States, 49503

Billings

St. Vincent Frontier Cancer Center-Research ( Site 0037), Billings, Montana, United States, 59102

Roanoke

Blue Ridge Cancer Care ( Site 0024), Roanoke, Virginia, United States, 24014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2031-01-06