Merck,MK-2400-001, Ph 3, open label, Prostate Ca, Ifinatamab Deruxtecan Versus Docetaxel

What is the Purpose of this Study?

Primary Objective: To compare infinatamab deruxtecan (I-DXd) to docetaxel with respect to overall survival (OS) in participants with mCRPC. To compare I-DXd to docetaxel with respect to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with mCRPC. Secondary Objectives: To evaluate the TFST of participants treated with I-DXd compared with participants treated with docetaxel. To evaluate the OR and DOR per PCWG Modified RECIST 1.1 as assessed by BICR of participants treated with I-DXd compared with participants treated with docetaxel. To evaluate the Time to Pain Progression (TTPP) of participants treated with I-DXd compared with participants treated with docetaxel. To evaluate the time to PSA progression of participants treated with I-DXd compared with participants treated with docetaxel. To evaluate the


Eligibility

  • * 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
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Where can I participate?

  • CS Cancer at Beverly Hills : Maria Tarallo
  • CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo


More about this Clinical Trial

What is the full name of this clinical trial?

MK-2400-001: A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants with Metastatic Castration-Resistant Prostate Cancer

Study Details
Disease Type/Condition

Prostate

Principal Investigator

Posadas, Edwin

Co-Investigators

David Hoffman, Jeremy Lorber, Jun Gong, Kevin Scher, Robert Figlin

Age Group

Adult

Phase

III

IRB Number

STUDY00004085

ClinicalTrials.gov ID

NCT06925737

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org
Study Detail
Disease Type/Condition

Prostate

Principal Investigator

Posadas, Edwin

Age Group

Adult

Phase

III

IRB Number

MK-2400-001

ClinicalTrials.gov ID

NCT06925737

Key Eligibility
ClinicalTrials.gov

Contact
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org