A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Recruiting · NCT06925737 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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:
- Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
- Has current ILD/pneumonitis
- 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
Where it is running
60 locations listed across 27 US states.
- Mayo Clinic in Arizona - Phoenix ( Site 0044) - Phoenix, Arizona, United States
- City of Hope Comprehensive Cancer Center ( Site 0049) - Duarte, California, United States
- City of Hope Lennar Foundation Cancer Center ( Site 0059) - Irvine, California, United States
- Moores Cancer Center ( Site 0010) - La Jolla, California, United States
- Veterans Affairs Long Beach Healthcare System ( Site 0058) - Long Beach, California, United States
- Cedars-Sinai Medical Center ( Site 0068) - Los Angeles, California, United States
- UCLA Hematology/Oncology - Santa Monica ( Site 0002) - Los Angeles, California, United States
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006) - Orange, California, United States
- Stanford Cancer Center ( Site 0046) - Palo Alto, California, United States
- Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053) - Aurora, Colorado, United States
- Yale-New Haven Hospital-Yale Cancer Center ( Site 0050) - New Haven, Connecticut, United States
- Veterans Affairs Connecticut Healthcare System ( Site 0062) - West Haven, Connecticut, United States
- The GW Medical Faculty Associates ( Site 0057) - Washington D.C., District of Columbia, United States
- Washington DC Veterans Affairs Medical Center ( Site 0056) - Washington D.C., District of Columbia, United States
- Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077) - Jacksonville, Florida, United States
- Emory University School of Medicine- Grady Campus ( Site 0103) - Atlanta, Georgia, United States
- Winship Cancer Institute, Emory University ( Site 0003) - Atlanta, Georgia, United States
- Rush University Medical Center-Hematology and Oncology ( Site 0028) - Chicago, Illinois, United States
- University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063) - Chicago, Illinois, United States
- University of Kentucky Chandler Medical Center ( Site 0048) - Lexington, Kentucky, United States
- Greenebaum Comprehensive Cancer Center ( Site 0021) - Baltimore, Maryland, United States
- Beth Israel Deaconess Medical Center ( Site 0043) - Boston, Massachusetts, United States
- Dana Farber Cancer Institute ( Site 0012) - Boston, Massachusetts, United States
- University of Michigan ( Site 0005) - Ann Arbor, Michigan, United States
- Henry Ford Hospital ( Site 0035) - Detroit, Michigan, United States
- Cancer and Hematology Centers of Western Michigan ( Site 0015) - Grand Rapids, Michigan, United States
- Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078) - Rochester, Minnesota, United States
- HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032) - Saint Louis Park, Minnesota, United States
- HealthPartners Cancer Center at Regions Hospital ( Site 0052) - Saint Paul, Minnesota, United States
- St. Vincent Frontier Cancer Center-Research ( Site 0037) - Billings, Montana, United States
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076) - Grand Island, Nebraska, United States
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026) - Omaha, Nebraska, United States
- Comprehensive Cancer Centers of Nevada ( Site 0082) - Las Vegas, Nevada, United States
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) - Hackensack, New Jersey, United States
- University of New Mexico Comprehensive Cancer Center ( Site 0022) - Albuquerque, New Mexico, United States
- Icahn School of Medicine at Mount Sinai ( Site 0009) - New York, New York, United States
- Great Lakes Cancer Care ( Site 0047) - Williamsville, New York, United States
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0061) - Columbus, Ohio, United States
- VA Portland Health Care System ( Site 0038) - Portland, Oregon, United States
- Perelman Center for Advanced Medicine ( Site 0067) - Philadelphia, Pennsylvania, United States
- Abramson Cancer Center - Penn Medicine ( Site 0079) - Philadelphia, Pennsylvania, United States
- Memphis VA Medical Center ( Site 0072) - Memphis, Tennessee, United States
- SCRI Oncology Partners ( Site 0074) - Nashville, Tennessee, United States
- Henry-Joyce Cancer Clinic ( Site 0042) - Nashville, Tennessee, United States
- Parkland Health & Hospital System ( Site 0069) - Dallas, Texas, United States
- UT Southwestern Medical Center ( Site 0039) - Dallas, Texas, United States
- University of Texas-MD Anderson Cancer Center ( Site 0055) - Houston, Texas, United States
- Blue Ridge Cancer Care ( Site 0024) - Roanoke, Virginia, United States
- VA Puget Sound Health Care System ( Site 0054) - Seattle, Washington, United States
- Fred Hutchinson Cancer Center ( Site 0060) - Seattle, Washington, United States
- University Hospital and UW Health Clinics ( Site 0065) - Madison, Wisconsin, United States
- Medical College of Wisconsin ( Site 0008) - Milwaukee, Wisconsin, United States
- Adana Medical Park Seyhan Hastanesi ( Site 0906) - Adana, Turkey (Türkiye)
- Hacettepe Universitesi Tip Fakultesi ( Site 0895) - Ankara, Turkey (Türkiye)
- Gazi University Health Research and Application Center Gazi Hospital ( Site 0903) - Ankara, Turkey (Türkiye)
- Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0901) - Ankara, Turkey (Türkiye)
- Azienda USL 8 di Arezzo ( Site 0503) - Arezzo, Italy
- Hospital del Mar ( Site 0822) - Barcelona, Spain
- Hospital Vall D Hebron ( Site 0814) - Barcelona, Spain
- Humanitas Gavazzeni ( Site 0508) - Bergamo, Italy
Showing 60 of 298 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →