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

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

  • Prostate Cancer
  • Prostatic Neoplasms

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