PasritamigPlaceboBest Supportive Care (BSC)JNJ-87189401
Pasritamig: Pasritamig will be administrated through IV infusion.
Placebo: Placebo will be administrated through IV infusion.
Best Supportive Care (BSC): BSC will be administered at the discretion of the treating physician.
JNJ-87189401: JNJ-87189401 will be administered.
Study summary
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).
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
* 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
2. The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period
Radioligand therapy: Required to have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies:
1. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.
2. The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.
Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Required to have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available
* Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog \[agonist or antagonist\]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Participants are eligible if they have the following values:
A) eGFR ≥ 40 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (≤) 3 times the Upper Limit of Normal (ULN) C) Total bilirubin \<1.5 times ULN D) Absolute neutrophil count (ANC) ≥ 1.0x10\^9/per liter (L) E) Hemoglobin ≥ 8.0 grams per deciliter (g/dL) F) Platelet count ≥ 75x10\^9/L
Exclusion Criteria
* 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
Primary outcome measure(s)
Overall Survival (OS) — Up to 2 years and 8 months OS is defined as the time from randomization to date of death due to any cause.
Trial sites (173)
Facility
City
Region
Status
University of California at San Diego
La Jolla
California
Recruiting
Cedars Sinai Medical Center
Los Angeles
California
Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles
California
Recruiting
San Francisco VA Medical Center
San Francisco
California
Recruiting
Rocky Mountain Cancer Centers
Aurora
Colorado
Recruiting
University of Colorado Cancer Center
Aurora
Colorado
Recruiting
Colorado Clinical Research
Lakewood
Colorado
Recruiting
Hartford Hospital
Hartford
Connecticut
Recruiting
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C.
District of Columbia
Recruiting
Bay Pines VA Healthcare System
Bay Pines
Florida
Recruiting
Florida Cancer Specialists & Research Institute
Fort Myers
Florida
Recruiting
Moffitt Cancer Center
Tampa
Florida
Recruiting
University of Iowa Hospital and Clinics
Iowa City
Iowa
Recruiting
Mission Cancer Blood
Waukee
Iowa
Recruiting
East Jefferson General Hospital
Metairie
Louisiana
Recruiting
Johns Hopkins University
Baltimore
Maryland
Recruiting
Dana Farber Cancer Institute
Boston
Massachusetts
Recruiting
University of Michigan Health System
Ann Arbor
Michigan
Recruiting
Henry Ford Cancer Detroit
Detroit
Michigan
Recruiting
University Of Minnesota Medical Center
Minneapolis
Minnesota
Recruiting
XCancer Omaha / Urology Cancer Center
Omaha
Nebraska
Recruiting
NYU Langone Hospitals
Brooklyn
New York
Recruiting
NYU Langone Hospital Long Island
Mineola
New York
Recruiting
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York
New York
Recruiting
Columbia University Medical Center
New York
New York
Recruiting
Levine Cancer Institute
Charlotte
North Carolina
Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem
North Carolina
Recruiting
University of Cincinnati
Cincinnati
Ohio
Recruiting
University Hospital of Cleveland
Cleveland
Ohio
Recruiting
Compass Oncology
Portland
Oregon
Completed
VA Portland Health Care System
Portland
Oregon
Recruiting
Oregon Urology Institute
Springfield
Oregon
Recruiting
MidLantic Urology
Bala-Cynwyd
Pennsylvania
Recruiting
Keystone Urology Specialists
Lancaster
Pennsylvania
Recruiting
Penn Medicine Abramson Cancer Center
Philadelphia
Pennsylvania
Recruiting
UPMC Cancer Centers
Pittsburgh
Pennsylvania
Recruiting
Ralph H Johnson Veterans Hospital
Charleston
South Carolina
Recruiting
Gibbs Cancer Center and Research Institute Pelham
Greer
South Carolina
Recruiting
Carolina Urologic Research Center
Myrtle Beach
South Carolina
Recruiting
Gibbs Cancer Center
Spartanburg
South Carolina
Recruiting
+ 133 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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