Ifinatamab Deruxtecan for Prostate Cancer

Recruiting at 8 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Androgen deprivation

Must not be taking: Taxane chemotherapy

Disqualifiers: Interstitial lung disease, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 36 months

1440 Participants Needed

Trial Summary

What is the purpose of this trial?

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,

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for individuals with metastatic castration-resistant prostate cancer (mCRPC) who have seen their cancer progress while on hormone therapy within the last 6 months. Participants must have previously been treated with 1 or 2 androgen receptor pathway inhibitors for at least 8 weeks.

Inclusion Criteria

I've had treatment with hormone blockers for at least 8 weeks and my cancer still grew.

I have advanced prostate cancer that is not responding to hormone therapy.

My prostate cancer got worse while on hormone therapy in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either I-DXd 12mg/kg every 3 weeks or docetaxel 75 mg/m^2 every 3 weeks with prednisone 10 mg/day

Up to approximately 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 36 months

Treatment Details

Interventions

• Ifinatamab Deruxtecan

Trial Overview The study compares a new medication, Ifinatamab Deruxtecan (I-DXd), against standard chemotherapy to see if I-DXd can help patients live longer overall and delay the growth or spread of cancer in those with mCRPC.

Participant Groups

Group I: I-DXd Experimental Treatment 1 Intervention

Participants receive I-DXd 12mg/kg every 3 weeks (q3w)

Group II: Docetaxel Active Control 2 Interventions

Participants receive docetaxel 75 mg//m\^2 q3w and prednisone 10 mg/day or per approved product label

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD