Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-64041809 (Cohort 1A and 1B)
JNJ-64041809 · 1 trial · 1 indication
Percentage of Participants who Experienced DLT will be evaluated. The DLT dose level is defined as an unacceptable level of toxicity as evidenced by a DLT rate of greater than or equal to (\>=) 33 percent (%).
Biomarker studies will be performed to evaluate immune responses to the vaccine after the first intravenous (IV) immunization.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Incidence was defined as the number of participants who experienced an adverse event within their period of participation in this study. Incidence of adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
| Arm | Type | Description |
|---|---|---|
| Dose Cohort 1A and 1B | EXPERIMENTAL | JNJ-64041809 will be administered intravenously (IV) once every 21 days. |
| Dose Cohort 2A and 2B | EXPERIMENTAL | JNJ-64041809 will be administered intravenously (IV) once every 21 days. |
| Name | Type | Description |
|---|---|---|
| JNJ-64041809 (Cohort 1A and 1B) | BIOLOGICAL | JNJ-64041809 will be administered IV at a lower dose in Cohort 1A (1x10\^8 colony forming units \[CFU\]) and at a higher dose in Cohort 1B (1x10\^9 CFU). |
| JNJ-64041809 (Cohort 2A and 2B) | BIOLOGICAL | JNJ-64041809 will be administered intravenously (IV) once every 21 days at the recommended dose as determined in Cohort 1A or 1B. |
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate with progressive metastatic disease which, in the opinion of the investigator, requires initiation of new treatment. The assessment of disease progression can be based on either PSA rise, new or progressive soft tissue di...