Health Trials

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

ConditionsProstate CancerProstatic Neoplasms
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorMerck Sharp & Dohme LLC

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Is unable to swallow tablets/capsules

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

1,440 Participants
are divided into 2 treatment groups
Group A: I-DXdExperimental treatment 2 interventions
Group B: DocetaxelActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

OS is defined as the time from randomization to death due to any cause.

Time frame
Up to approximately 36 months
2

Radiographic Progression Free Survival (rPFS)

rPFS is defined as the time from randomization to the first documented disease progression per prostate cancer working group (PCWG)-modifed Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first.

Time frame
Up to approximately 36 months

Secondary outcomes

1

Time to First Subsequent Therapy (TFST)

TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.

Time frame
Up to approximately 36 months
2

Objective Response Rate (ORR)

The ORR is defined as a confirmed complete response (CR) or partial response (PR) per PCWG-modified RECIST 1.1 as assessed by BICR.

Time frame
Up to approximately 36 months
3

Duration of Response (DOR)

For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first.

Time frame
Up to approximately 36 months
4

Time to Pain Progression (TTPP)

TTPP is defined as the time from randomization to pain progression based on the brief pain inventory-short form (BPI-SF) Item 3 "worst pain in 24 hours" and opiate analgesic use (AQA score).

Time frame
Up to approximately 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator

Source ClinicalTrials.gov
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