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

Conditions

• Prostate Cancer
• Prostatic Neoplasms

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ifinatamab deruxtecan — DRUG
  Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
• Docetaxel — DRUG
  Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
• Prednisone — DRUG
  Oral tablet administered once per day or per approved product label
• Rescue Medication — DRUG
  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

Study Details

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.

Key Dates

Start date

May 13, 2025

Status verified

May 2026

Primary completion

Jun 26, 2028

Completion

Jan 6, 2031

Study Design

Enrollment

1,440 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: I-DXd
  Participants receive I-DXd 12mg/kg every 3 weeks (q3w)
• Active Comparator: Docetaxel
  Participants receive docetaxel 75 mg/m\^2 q3w and prednisone 10 mg/day or per approved product label

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 36 months ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (50)

Find similar trials in Phoenix, AZ

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