Print

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

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 metastasis to visceral organs at the time of screening - 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. 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 * ULN D) Absolute neutrophil count (ANC) >= 1.0 *10^9/per liter (L) E) Hemoglobin >= 8.0 grams per deciliter (g/dL) F) Platelet count >= 75 * 109/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) - 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 (Cycle 1 duration is 8 weeks). From C2D1 onwards ( Cycle Duration is 6 week), participants will receive pasritamig target dose IV every 6 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 as per 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 and 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 as per physician.

Recruiting Locations

Rocky Mountain Cancer Centers
Aurora 5412347, Colorado 5417618 80012

Colorado Clinical Research
Lakewood 5427946, Colorado 5417618 80228

Bay Pines VA Healthcare System
Bay Pines 4146855, Florida 4155751 33744

Florida Cancer Specialists & Research Institute
Fort Myers 4155995, Florida 4155751 33901

East Jefferson General Hospital
Metairie 4333177, Louisiana 4331987 70006

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

XCancer Omaha / Urology Cancer Center
Omaha 5074472, Nebraska 5073708 68130

NYU Langone Hospitals
Brooklyn 5110302, New York 5128638 11220

NYU Langone Hospital Long Island
Mineola 5127134, New York 5128638 11501

NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York 5128581, New York 5128638 10016

University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45219

Compass Oncology
Portland 5746545, Oregon 5744337 97227

Oregon Urology Institute
Springfield 5754005, Oregon 5744337 97477

MidLantic Urology
Bala-Cynwyd 5178892, Pennsylvania 6254927 19004

Keystone Urology Specialists
Lancaster 5197079, Pennsylvania 6254927 17601

UPMC Cancer Centers
Pittsburgh 5206379, Pennsylvania 6254927 15232

Carolina Urologic Research Center
Myrtle Beach 4588718, South Carolina 4597040 29572

Gibbs Cancer Center
Spartanburg 4597200, South Carolina 4597040 29303

Tennessee Oncology
Chattanooga 4612862, Tennessee 4662168 37404

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203

Urology Clinics of North Texas
Dallas 4684888, Texas 4736286 75231

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Texas Oncology West Texas
Wichita Falls 4741752, Texas 4736286 76310

Virginia Cancer Specialists
Fairfax 4758023, Virginia 6254928 22031

Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502

Blue Ridge Cancer Care
Roanoke 4782167, Virginia 6254928 24014

Puerto Rico Medical Research Center
Hato Rey, Puerto Rico 00970

Pan American Center for Oncology Trials LLC
Rio Piedras 4829037, Puerto Rico 00935

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.