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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,440
Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Mayo Clinic in Arizona - Phoenix ( Site 0044)
Phoenix, Arizona, United States
RECRUITINGCity of Hope Comprehensive Cancer Center ( Site 0049)
Duarte, California, United States
RECRUITINGCity of Hope Lennar Foundation Cancer Center ( Site 0059)
Irvine, California, United States
RECRUITINGMoores Cancer Center ( Site 0010)
La Jolla, California, United States
RECRUITINGVeterans Affairs Long Beach Healthcare System ( Site 0058)
Long Beach, California, United States
RECRUITINGCedars-Sinai Medical Center ( Site 0068)
Los Angeles, California, United States
RECRUITINGUCLA Hematology/Oncology - Santa Monica ( Site 0002)
Los Angeles, California, United States
RECRUITINGUniversity of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006)
Orange, California, United States
RECRUITINGStanford Cancer Center ( Site 0046)
Palo Alto, California, United States
RECRUITINGRocky Mountain Regional Veterans Affairs Medical Center ( Site 0053)
Aurora, Colorado, United States
RECRUITING...and 288 more locations
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