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

Mayo Clinic in Arizona - Phoenix ( Site 0044)
Phoenix, Arizona 85054
Contact:
Study Coordinator
855-776-0015

City of Hope Comprehensive Cancer Center ( Site 0049)
Duarte, California 91010
Contact:
Study Coordinator
626-256-4673

City of Hope Lennar Foundation Cancer Center ( Site 0059)
Irvine, California 92618
Contact:
Study Coordinator
626-256-4673

Moores Cancer Center ( Site 0010)
La Jolla, California 92093
Contact:
Study Coordinator
858-822-6100

Cedars-Sinai Medical Center ( Site 0068)
Los Angeles, California 90048
Contact:
Study Coordinator
310-423-7600

UCLA Hematology/Oncology - Santa Monica ( Site 0002)
Los Angeles, California 90404
Contact:
Study Coordinator
310-825-2631

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006)
Orange, California 92868
Contact:
Study Coordinator
714-509-2371

Stanford Cancer Center ( Site 0046)
Palo Alto, California 94304
Contact:
Study Coordinator
650-725-2078

Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053)
Aurora, Colorado 80045
Contact:
Study Coordinator
303-399-8020

Yale-New Haven Hospital-Yale Cancer Center ( Site 0050)
New Haven, Connecticut 06510
Contact:
Study Coordinator
203-737-6087

Veterans Affairs Connecticut Healthcare System ( Site 0062)
West Haven, Connecticut 06516
Contact:
Study Coordinator
203-932-5711

The GW Medical Faculty Associates ( Site 0057)
Washington D.C., District of Columbia 20037
Contact:
Study Coordinator
202-994-2758

Washington DC Veterans Affairs Medical Center ( Site 0056)
Washington D.C., District of Columbia 20422
Contact:
Study Coordinator
202-745-8000

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077)
Jacksonville, Florida 32224
Contact:
Study Coordinator
855-776-0015

Emory University School of Medicine- Grady Campus ( Site 0103)
Atlanta, Georgia 30303
Contact:
Study Coordinator
404-727-6123

Winship Cancer Institute, Emory University ( Site 0003)
Atlanta, Georgia 30322
Contact:
Study Coordinator
404-778-4824

University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063)
Chicago, Illinois 60612
Contact:
Study Coordinator
312-355-1625

University of Kentucky Chandler Medical Center ( Site 0048)
Lexington, Kentucky 40536
Contact:
Study Coordinator
866-340-4488

Greenebaum Comprehensive Cancer Center ( Site 0021)
Baltimore, Maryland 21201
Contact:
Study Coordinator
410-707-4011

Beth Israel Deaconess Medical Center ( Site 0043)
Boston, Massachusetts 02215
Contact:
Study Coordinator
617-667-2100

Dana Farber Cancer Institute ( Site 0012)
Boston, Massachusetts 02215
Contact:
Study Coordinator
617-632-6049

University of Michigan ( Site 0005)
Ann Arbor, Michigan 48109
Contact:
Study Coordinator
734-647-8902

Henry Ford Hospital ( Site 0035)
Detroit, Michigan 48202
Contact:
Study Coordinator
313-725-7920

Cancer and Hematology Centers of Western Michigan ( Site 0015)
Grand Rapids, Michigan 49503
Contact:
Study Coordinator
616-399-6500

Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078)
Rochester, Minnesota 55905
Contact:
Study Coordinator
855-776-0015

HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032)
Saint Louis Park, Minnesota 55426
Contact:
Study Coordinator
612-341-4800

HealthPartners Cancer Center at Regions Hospital ( Site 0052)
Saint Paul, Minnesota 55101
Contact:
Study Coordinator
612-341-4800

St. Vincent Frontier Cancer Center-Research ( Site 0037)
Billings, Montana 59102
Contact:
Study Coordinator
406-238-6290

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076)
Grand Island, Nebraska 68803
Contact:
Study Coordinator
402-334-4773

Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
Omaha, Nebraska 68130
Contact:
Study Coordinator
402-334-4773

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey 07601
Contact:
Study Coordinator
551-996-5900

University of New Mexico Comprehensive Cancer Center ( Site 0022)
Albuquerque, New Mexico 87131
Contact:
Study Coordinator
505-272-4946

Icahn School of Medicine at Mount Sinai ( Site 0009)
New York, New York 10029
Contact:
Study Coordinator
212-241-6756

Great Lakes Cancer Care ( Site 0047)
Williamsville, New York 14221
Contact:
Study Coordinator
716-884-3000

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0061)
Columbus, Ohio 43221
Contact:
Study Coordinator
619-228-4010

VA Portland Health Care System ( Site 0038)
Portland, Oregon 97239
Contact:
Study Coordinator
503-220-8262

Perelman Center for Advanced Medicine ( Site 0067)
Philadelphia, Pennsylvania 19104
Contact:
Study Coordinator
215-360-0737

Abramson Cancer Center - Penn Medicine ( Site 0079)
Philadelphia, Pennsylvania 19106
Contact:
Study Coordinator
215-829-6088

Memphis VA Medical Center ( Site 0072)
Memphis, Tennessee 38105
Contact:
Study Coordinator
901-523-8990

SCRI Oncology Partners ( Site 0074)
Nashville, Tennessee 37203
Contact:
Study Coordinator
615-329-7640

UT Southwestern Medical Center ( Site 0039)
Dallas, Texas 75390
Contact:
Study Coordinator
972-332-4682

University of Texas-MD Anderson Cancer Center ( Site 0055)
Houston, Texas 77030
Contact:
Study Coordinator
877-632-6789

Blue Ridge Cancer Care ( Site 0024)
Roanoke, Virginia 24014
Contact:
Study Coordinator
540-982-0237

VA Puget Sound Health Care System ( Site 0054)
Seattle, Washington 98108
Contact:
Study Coordinator
206-762-1010

Fred Hutchinson Cancer Center ( Site 0060)
Seattle, Washington 98109
Contact:
Study Coordinator
206-606-7307

University Hospital and UW Health Clinics ( Site 0065)
Madison, Wisconsin 53792
Contact:
Study Coordinator
608-915-0100

Medical College of Wisconsin ( Site 0008)
Milwaukee, Wisconsin 53226
Contact:
Study Coordinator
414-805-0509

More Details

NCT ID
NCT06925737
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

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