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)

Purpose

The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: - The safety of the study treatment and if people tolerate it. - A safe dose level of I-DXd that can be used with other treatments. - Participant levels of prostate specific antigen (PSA) during treatment.

Conditions

  • Castration-Resistant Prostatic Cancer
  • Metastasis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

The main inclusion criteria include but are not limited to the following: - 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

Exclusion Criteria

The main exclusion criteria include but are not limited to the following: - 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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Docetaxel
Participants will receive docetaxel at a determined dose every 3 weeks (Q3W) for a maximum of 10 cycles. Each cycle is 21 days.
  • Drug: Docetaxel
    Administered via Intravenous (IV) infusion at a specified dose on specified days
Experimental
Ifinatamab Deruxtecan (I-DXd)
Participants will receive I-DXd at a determined dose Q3W until unacceptable toxicity, progressive disease (PD), death or withdrawal of consent.
  • Drug: Ifinatamab Deruxtecan
    Administered via IV infusion at a specified dose on specified days
    Other names:
    • I-DXd, MK-2400, DS-7300a
Experimental
I-DXd + MK-5684
Following a dose escalation regimen with I-DXd, participants will receive I-DXd at a determined dose until unacceptable toxicity, PD, death or withdrawal of consent PLUS MK-5684 at a determined dose until any of the criterion for discontinuation of study intervention is met.
  • Drug: Ifinatamab Deruxtecan
    Administered via IV infusion at a specified dose on specified days
    Other names:
    • I-DXd, MK-2400, DS-7300a
  • Drug: MK-5684
    Administered orally at a specified dose on specified days
    Other names:
    • ODM-208
Experimental
I-DXd +ARPI (Abiraterone or Enzalutamide)
Following a dose escalation regimen with I-DXd, participants will receive I-DXd at a determined dose until unacceptable toxicity, PD, death or withdrawal of consent PLUS ARPI (Androgen Receptor Pathway Inhibitor) - Abiraterone acetate OR Enzalutamide at a determined dose until any of the criterion for discontinuation of study intervention is met.
  • Drug: Ifinatamab Deruxtecan
    Administered via IV infusion at a specified dose on specified days
    Other names:
    • I-DXd, MK-2400, DS-7300a
  • Drug: Abiraterone
    Administered orally at a specified dose on specified days
  • Drug: Enzalutamide
    Administered orally at a specified dose on specified days

Recruiting Locations

MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)
Washington D.C. 4140963, District of Columbia 4138106 20010
Contact:
Study Coordinator
202-877-3061

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Detailed Description

This sub study MK-2400-01A assesses treatments for metastatic castration-resistant prostate cancer (mCRPC). The master screening protocol is MK-2400-U01.