A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Purpose

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 combination with best supportive care (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).

Condition

  • Metastatic Castration-resistant Prostate Neoplasms

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts 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 - 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 should 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: Should 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. Participants who cannot continue taxane therapy because of a documented Grade>=3 taxane related IRR are eligible for enrollment, even if they received fewer than 2 prior cycles of taxane treatment Radioligand therapy: Should 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): Should 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 >= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (<=) 5 times the Upper Limit of Normal (ULN) C) Serum total bilirubin <= 3 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pasritamig Plus Best Supportive Care (BSC) 		Participants will receive the step-up doses of pasritamig intravenously (IV) on Cycle 1 Day 1 (C1D1) and C1D8, and target dose of pasritamig IV on C1D15. From C2D1 onwards participants will receive pasritamig target dose IV every 6 weeks. All Cycles are 6 weeks, except for Cycle 1 which is 8 weeks. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.
  • Biological: Pasritamig
    Pasritamig will be administrated through IV infusion.
    Other names:
    • JNJ-78278343
  • Drug: Best Supportive Care (BSC)
    BSC will be administered at the discretion of the treating physician.
Placebo Comparator
Placebo Plus BSC 		Participants will receive the step-up doses of placebo IV on C1D1 and C1D8, and target dose of placebo on C1D15. From C2D1 onwards, participants will receive placebo target dose IV every 6 weeks. All Cycles are 6 weeks, except for Cycle 1 which is 8 weeks. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC at the discretion of the physician.
  • Other: Placebo
    Placebo will be administrated through IV infusion.
  • Drug: Best Supportive Care (BSC)
    BSC will be administered at the discretion of the treating physician.

Recruiting Locations

University of California at San Diego
La Jolla, California 92093

Rocky Mountain Cancer Centers
Aurora, Colorado 80012

University of Colorado Cancer Center
Aurora, Colorado 80045

Colorado Clinical Research
Lakewood, Colorado 80228

Hartford Hospital
Hartford, Connecticut 06102

Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia 20016

Bay Pines VA Healthcare System
Bay Pines, Florida 33744

Florida Cancer Specialists & Research Institute
Fort Myers, Florida 33901

Moffitt Cancer Center
Tampa, Florida 33612

East Jefferson General Hospital
Metairie, Louisiana 70006

Johns Hopkins University
Baltimore, Maryland 21287

Dana Farber Cancer Institute
Boston, Massachusetts 02115

University of Michigan Health System
Ann Arbor, Michigan 48109

Henry Ford Cancer Detroit
Detroit, Michigan 48202

University Of Minnesota Medical Center
Minneapolis, Minnesota 55455

XCancer Omaha / Urology Cancer Center
Omaha, Nebraska 68130

NYU Langone Hospitals
Brooklyn, New York 11220

NYU Langone Hospital Long Island
Mineola, New York 11501

NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York 10016

Columbia University Medical Center
New York, New York 10032

University of Cincinnati
Cincinnati, Ohio 45219

University Hospital of Cleveland
Cleveland, Ohio 44106

Compass Oncology
Portland, Oregon 97227

Oregon Urology Institute
Springfield, Oregon 97477

MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004

Keystone Urology Specialists
Lancaster, Pennsylvania 17601

Penn Medicine Abramson Cancer Center
Philadelphia, Pennsylvania 19104

UPMC Cancer Centers
Pittsburgh, Pennsylvania 15232

Ralph H Johnson Veterans Hospital
Charleston, South Carolina 29401

Gibbs Cancer Center and Research Institute Pelham
Greer, South Carolina 29650

Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572

Gibbs Cancer Center
Spartanburg, South Carolina 29303

Tennessee Oncology - Chattanooga
Chattanooga, Tennessee 37404

Tennessee Oncology Nashville
Nashville, Tennessee 37203

Urology Clinics of North Texas
Dallas, Texas 75231

UT Southwestern Medical Center
Dallas, Texas 75390

MD Anderson Cancer Center
Houston, Texas 77030

Michael E DeBakey VA Medical Center
Houston, Texas 77030

Texas Oncology West Texas
Wichita Falls, Texas 76310

Utah Cancer Specialists
Salt Lake City, Utah 84106

Virginia Cancer Specialists
Fairfax, Virginia 22031

Virginia Oncology Associates
Norfolk, Virginia 23502

Blue Ridge Cancer Care
Roanoke, Virginia 24014

VA Puget Sound Healthcare System
Seattle, Washington 98108

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109

University of Washington
Seattle, Washington 98195

Pan American Center for Oncology Trials LLC
Rio Piedras, Puerto Rico 00935

Puerto Rico Medical Research Center
San Juan, Puerto Rico 00917

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com