Castration-resistant Metastatic Prostate Cancer MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Opdivo (100 mg/10 ml)
Product Name: NIVOLUMAB
Product Code: BMS-936558
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: 946414-94-4
Cur
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Histologic confirmation of adenocarcinoma of the prostate - Evidence of metastatic disease - Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast - Participants with active brain metastases - Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the objective response rate per PCWG3 (ORR-PCWG3) in HRD+ participants and in all treated participants - To evaluate PSA response rate (RR-PSA) in HRD+ participants and in all treated participants;Secondary Objective: - To evaluate radiographic progression-free survival (rPFS) in HRD+ participants and in all treated participants - To evaluate time to response (TTR) and duration of response (DOR) per PCWG3 (TTR-PCWG3 and DOR-PCWG3) in HRD+ participants and in all treated participants - To estimate time to PSA progression (TTP-PSA) in HRD+ participants and in all treated participants - To assess overall survival (OS) in HRD+ participants and in all treated participants - To evaluate overall safety and tolerability;Primary end point(s): 1/ Objective Response Rate (ORR) 2/ Prostate-specific antigen response rate (RR-PSA);Timepoint(s) of evaluation of this end point: 1/ Approximately 12 months 2/ Approximately 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ Radiographic progression-free survival (rPFS) 2/ Time to response (TTR) 3/ Duration of response (DOR) 4/ Time to prostate-specific antigen progression (TTP-PSA) 5/ Overall Survival (OS) 6/ Incidence of adverse events (AEs) 7/ Incidence of serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: 1/ Approximately 12 months 2/ Approximately 12 months 3/ Approximately 12 months 4/ Approximately 12 months 5/ Up to 5 years 6/ Approximately 12 months 7/ Approximately 12 months | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Mexico, Spain
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed