The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
277
JNJ-78278343 will be administered.
Cetrelimab will be administered by intravenous infusion.
Cabazitaxel will be administered by intravenous infusion.
Docetaxel will be administered by intravenous infusion.
Apalutamide will be administered orally.
Enzalutamide will be administered orally.
Darolutamide will be administered orally.
Abiraterone acetate plus prednisone (AAP) will be administered orally.
Florida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGStart Midwest
Grand Rapids, Michigan, United States
RECRUITINGWashington University School Of Medicine
St Louis, Missouri, United States
RECRUITINGPerlmutter Cancer Center at NYU Langone Brooklyn
Brooklyn, New York, United States
RECRUITINGLaura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGSidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States
RECRUITINGIcon Cancer Centre Kurralta Park
Kurralta Park, Australia
RECRUITINGMacquarie University
Macquarie University, Australia
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Australia
RECRUITING...and 5 more locations
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Time frame: Up to 21 days after first dose of combination agent
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
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. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Time frame: Up to 2 years 11 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria.
Time frame: Up to 2 years 11 months
Prostate Specific Antigen (PSA) Response Rate
PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
Time frame: Up to 2 years 11 months
Radiographic Progression-free Survival (rPFS)
rPFS is defined time from the date of first dose of JNJ-78278343 until the date of objective disease progression or death, whichever comes first.
Time frame: Up to 2 years 11 months
Time to Response (TTR)
TTR is defined for the responders as the time from the date of first dose of to the date of first documented response that is subsequently confirmed.
Time frame: Up to 2 years 11 months
Duration of Response (DOR)
DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
Time frame: Up to 2 years 11 months
Part 2H: Composite Progression-Free Survival (PFS)
Composite PFS is defined as time from start of treatment to the date of first occurrence of investigator determined disease progression (Response Evaluation Criteria in Solid Tumors \[RECIST\] or bone progression), pain, PSA progression, death or last disease assessment, whichever occurs first.
Time frame: Up to 2 years 11 months
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