Clinical trial NCT06925737: A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Official title: A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Prostatic Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2025-04-13
Enrollment: 1440
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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,


Eligibility 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 36 months
measure: Radiographic Progression Free Survival (rPFS)
timeFrame: Up to approximately 36 months
Secondary outcomes:
measure: Time to First Subsequent Therapy (TFST)
timeFrame: Up to approximately 36 months
measure: Objective Response (OR)
timeFrame: Up to approximately 36 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 36 months
measure: Time to Pain Progression (TTPP)
timeFrame: Up to approximately 36 months
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: Up to approximately 36 months
measure: PSA Response
timeFrame: Up to approximately 36 months
measure: Time to First Symptomatic Skeletal-related Event (SSRE)
timeFrame: Up to approximately 36 months
measure: Number of Participants Who Experienced at least One Adverse Event (AE)
timeFrame: Up to approximately 36 months
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 36 months
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan ( Site 0015)
state: Michigan
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center-Research ( Site 0037)
state: Montana
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care ( Site 0024)
state: Virginia
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0462)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0460)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0463)
city: Dong-gu
country: Korea, Republic of
facility: Ulsan University Hospital ( Site 0793)
state: Ulsan-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0790)
city: Taiwan
country: Taiwan
facility: National Taiwan University Hospital ( Site 0870)
state: Taipei
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: