Last updated 6 days ago
A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)
360 patients around the world
This sub study MK-2400-01A assesses treatments for metastatic castration-resistant
prostate cancer (mCRPC).
The master screening protocol is MK-2400-U01.
Merck Sharp & Dohme LLC
2Research sites
360Patients around the world
This study is for people with
Prostate cancer
Castration resistant prostate cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 before Screening.Has current evidence of metastatic disease.Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment.Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before allocation/randomization.An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 10 days before allocation/randomization.Has prior treatment with poly-ADP-ribose polymerase inhibitors (PARPi) if indicated by local approved regimen or were deemed ineligible to receive PARPi by the investigator.
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis or suspected ILD/pneumonitis.Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.Uncontrolled or significant cardiovascular disease.History of pituitary dysfunction.Poorly controlled diabetes mellitus.History or current condition of adrenal insufficiency (eg, Addison's disease).Has received prior treatment with taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC).Chronic steroid treatment (dose of >10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease), topical steroids (for mild skin conditions), or intra-articular steroid injections.Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.Known additional malignancy that is progressing or has required active treatment within the past 3 years.Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.Active autoimmune disease that has required systemic treatment in the past 2 years.History of allogeneic tissue/solid organ transplant.
Sites
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
StudyMK-2400-01A/IDeate-Prostate02
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Castration resistant prostate cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06863272
