RecruitingMetastatic Castration-resistant Prostatic Neoplasms

A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Eligible age

18+ yrs

Accepts

Men

Locations

23 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).

Sponsor: Janssen Research & Development, LLC

You may qualify if…

✓ Histologically confirmed adenocarcinoma of the prostate
✓ Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (chest, abdomen, and pelvis) and 99m\^Tc bone scan. Visceral disease is not allowed
✓ PSA greater than or equal to (≥) 2 nanogram per milliliter (ng/mL) at screening
✓ In the opinion of the investigator, the next best treatment option is a clinical trial
✓ Participants are required to have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following:
✓ Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI
✓ Taxanes: Required to have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if:
✓ 1. Cabazitaxel is not available

You may not qualify if…

✕ Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤ 2) deep vein thrombosis is not exclusionary
✕ Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)
✕ Participants with Grade 1 or higher fever (≥38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are ineligible. Participants must be afebrile (\<38ºC) at the time of study treatment dosing unless approved by medical monitor
✕ Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (\>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation
✕ Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
✕ Any of the following within 6 months prior to first dose of study treatment:
✕ A) Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident
✕ \- Prior treatment with any CD3-directed therapy