Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

The main inclusion criteria include but are not limited to the following: - Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology - Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening - Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI) - Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment - Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy - Has recovered from adverse events (AEs) due to previous anticancer therapies

Exclusion Criteria

The main exclusion criteria include but are not limited to the following: - Is unable to swallow tablets/capsules - Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis: 1. Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids 2. Has current ILD/pneumonitis 3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out - Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses - Has uncontrolled or significant cardiovascular disease - Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC) - Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities - Has a "superscan" bone scan

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
I-DXd
Participants receive I-DXd 12mg/kg every 3 weeks (q3w)
  • Drug: Ifinatamab deruxtecan
    Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
    Other names:
    • I-DXd
    • MK-2400
    • DS-7300a
  • Drug: Rescue Medication
    Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label
    Other names:
    • 5-HT3 receptor antagonist
    • NK-1 receptor antagonist
    • Corticosteroid
Active Comparator
Docetaxel
Participants receive docetaxel 75 mg/m^2 q3w and prednisone 10 mg/day or per approved product label
  • Drug: Docetaxel
    Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
  • Drug: Prednisone
    Oral tablet administered once per day or per approved product label
    Other names:
    • Prednisone acetate
    • Prednisolone
    • Prednisolone acetate

Recruiting Locations

Henry-Joyce Cancer Clinic ( Site 0042)
Nashville, Tennessee 37232
Contact:
Study Coordinator
615-936-8422

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.