Metastatic Castration-resistant Prostate Neoplasms
Conditions
Brief 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 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).
Interventions
BIOLOGICALPasritamig
Pasritamig will be administrated through IV infusion.
OTHERPlacebo
Placebo will be administrated through IV infusion.
DRUGBest Supportive Care (BSC)
BSC will be administered as per physician.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Symptomatic Progression | Up to 2 years and 8 months | Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs first): (a) the use of external beam radiation therapy to relieve cancer-related symptoms; (b) the need for tumor-related orthopedic surgical intervention; (c) other cancer-related procedures; (d) cancer-related morbid events; (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms. |
| Time to Skeletal-Related Event | Up to 2 years and 8 months | Time to skeletal-related event is defined as the time from the date of randomization to the date of first occurrence of any of the following (whichever occurs first): (a) the use of external beam radiation for skeletal or pelvic symptoms; b) the need for tumor-related orthopedic surgical intervention; (c) the occurrence of new bone fractures (cancer-related); (d) the occurrence of tumor-related spinal cord compression. |
| Progression-Free Survival (PFS) | Up to 2 years and 8 months | PFS is defined as the date of randomization to the date of first evidence of radiographic progression, clinical progression, or death from any cause, whichever occurs first. |
| Time to Prostate Specific Antigen (PSA) Progression | Up to 2 years and 8 months | Time to PSA progression, defined as the time from randomization to the first date of documented PSA progression per PCWG3 criteria. PSA progression is defined as: after a decline from baseline, PSA increases \>= 25 percentage (%) and \>= 2 nanograms per milliliter (ng/mL) above the nadir, confirmed by a second value \>= 3 weeks later (that is, a confirmed rising trend), or If there is no decline from baseline, PSA increases \>= 25 % and \>= 2 ng/mL from baseline after 12 weeks. |
| Radiographic Progression-free Survival (rPFS) | Up to 2 years and 8 months | rPFS assessed by investigator defined as the time from the date of randomization until the date of radiographic disease progression (based on response evaluation criteria in solid tumors \[RECIST\] v1.1 and prostate cancer working group 3 \[PCWG3\] criteria) or death, whichever comes first. |
| Time to Deterioration in Fatigue as Assessed by the European Organisation For Research And Treatment of Cancer Quality of Life Questionnaire-Core-30 (EORTC QLQ-C30) Fatigue Scale Score | Up to 2 years and 8 months | Time to deterioration is defined as the time from randomization to the date of the first observation of deterioration in Fatigue. Deterioration in Fatigue is defined as an increase of 10 points on the EORTC QLQ-C30 FA scale observed at 2 consecutive evaluations \>= 3 weeks apart. The EORTC QLQ-C30 is a widely used tool for assessing the quality of life of cancer patients in clinical trials. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 Not at all to 4 Very much. Two global health status items are rated on a 7-point numeric rating scale from 1 Very Poor to 7 Excellent. Each subscale of the EORTC QLQ-C30 is scored on a range from 0 to 100. Higher scores indicate worse symptoms or problems. |
| Number of Participants with Adverse Events (AEs) | Up to 2 years and 8 months | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
| Number of Participants with Abnormalities in Clinical Laboratory Assessments | Up to 2 years and 8 months | Participants with abnormalities in clinical laboratory parameters (hematology, clinical chemistry etc.) will be assessed. |
| Time to Pain Progression (TTPP) as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) Item 3 Worst Pain in 24 Hours | Up to 2 years and 8 months | TTPP is defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression is defined as an increase of at least 2 points from baseline in the BPI-SF worst pain intensity (item 3) observed at 2 consecutive evaluations \>= 3 weeks apart. BPI-SF is an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score range from 0 to 10 with 0 representing no pain and 10 representing pain as bad as you can imagine. |
Countries
Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Netherlands, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
Primary ContactStudy Contact
Outcome results
None listed