A Phase 3 interventional study of Ifinatamab deruxtecan and Docetaxel in Prostate Cancer and Prostatic Neoplasms, sponsored by Merck Sharp & Dohme LLC. Recruiting at 303 sites in 35 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 1,440 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive I-DXd 12mg/kg every 3 weeks (q3w)
Drug: Ifinatamab deruxtecan · Drug: Rescue Medication
Participants receive docetaxel 75 mg/m\^2 q3w and prednisone 10 mg/day or per approved product label
Drug: Docetaxel · Drug: Prednisone
Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Also known as: I-DXd, MK-2400, DS-7300a
Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
Oral tablet administered once per day or per approved product label
Also known as: Prednisone acetate, Prednisolone, Prednisolone acetate
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
Also known as: 5-HT3 receptor antagonist, NK-1 receptor antagonist, Corticosteroid
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 36 months
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
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
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
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
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
Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression is defined as the time from randomization to PSA progression. The PSA progression date is defined as the first date that 1) ≥25% increase and ≥2 ng/mL above the nadir which is confirmed by a second value≥3 weeks later if there is PSA decline from baseline, 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.
Time frame: Up to approximately 36 months
PSA Response Rate
PSA response rate is defined as the proportion of participants in the analysis population who have a PSA reduction of ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG criteria.
Time frame: Up to approximately 36 months
Time to First Symptomatic Skeletal-Related Event (SSRE)
Time to first SSRE is defined as the time from randomization to the first occurrence of any of the following symptomatic skeletal-related events: 1. use of EBRT to prevent or relieve skeletal symptoms, 2. new symptomatic pathologic bone fracture (vertebral or non-vertebral), 3. spinal cord compression, 4. a tumor-related orthopedic surgical intervention.
Time frame: Up to approximately 36 months
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 36 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 36 months
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Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ifinatamab deruxtecan