Metastatic Castration-resistant Prostate Cancer (mCRPC) MedDRA version: 21.1 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: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Histologic confirmation of adenocarcinoma of the prostate and evidence of stage IV disease • Must have ECOG performance status 0-1 • Documented prostate cancer progression per PCWG3 criteria within 6 months prior to screening • Ongoing androgen deprivation therapy (ADT) with a gonadotropinreleasing hormone (GnRH) analogue or bilateral orchiectomy • Participants who are chemotherapy-naive and received 1 to 2 prior second generation hormonal therapies • Sufficient tumor sample from fresh or archival tumor tissue obtained no more than 1 year prior to enrollment, from a metastatic lesion or primary tumor lesion that has not been previously irradiated 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 328 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 656
Exclusion criteria
Exclusion criteria: • Participants with active brain metastases • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured • Participants with an active, known, or suspected autoimmune disease • Participants requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways • Prior treatment with docetaxel or another chemotherapy for metastatic castration resistant prostate cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG3) [Time Frame: Approximately 2 years] - Overall Survival (OS) [Time Frame: Approximately 3 years];Secondary Objective: - Objective Response Rate (ORR) per Prostate Cancer Working Group (PCWG3) [Time Frame: Approximately 3 years] - Duration of response (DOR) per Prostate Cancer Working Group (PCWG3) [Time Frame: Approximately 3 years] - PSA Response Rate (PSA-RR) [Time Frame: Approximately 3 years] - Time to Response per PCWG3 (TTR-PCWG3) assessed by BICR [Time Frame: Approximately 3 years] - Time to pain progression [Time Frame: Approximately 3 years] - Time to PSA Progression (TTP-PSA) [Time Frame: Approximately 3 years] - Incidence of AEs (Adverse Events) [Time Frame: Approximately 3 years] - Incidence of SAEs ( Serious Adverse Events) [Time Frame: Approximately 3 years];Primary end point(s): 1 - rPFS for all randomized participants is the time between randomization and the first date of documented progression or death due to any cause, whichever occurs first. The radiographic progression will be assessed by Blinded Independent Central Review (BICR) per PCWG3. The rPFS will be censored at the last tumor assessment up to the start of subsequent systemic cancer therapy for those without progression. 2 - OS for all randomized participants is the time between randomization and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive. OS will be censored for participants at the date of randomization if they had no follow-up.;Timepoint(s) of evaluation of this end point: During treatment and post treatment follow up until progression, death or lost of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Objective Response Rate per PCWG3 (ORR-PCWG3) is the proportion of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. The BOR is defined as the best response designation, as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression per PCWG3 or the date of subsequent systemic cancer therapy, whichever occurs first. For participants without documented progression or subsequent systemic cancer therapy, all available response assessments will contribute to the BOR assessment. - Time to Response per PCWG3 (TTR-PCWG3) is the time from randomization to the date of the first documented CR or PR per PCWG3, as determined by BICR. - Duration of Response per PCWG3 (DOR-PCWG3) is the time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3, as determined by BICR, or death due to any cause. Participants who neither progress nor die will be censored at the last tumor assessment up to the start of subsequent systemic cancer therapy. - PSA Response Rate (PSA-RR) is the proportion of randomized participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. - PSA response will be calculated for all participants with PSA values at baseline and at least one post baseline assessment. - Time to PSA Progression (TTP-PSA) is the time between randomization to the date of PSA progression per PCWG3 in randomized participants. For participants with an initial PSA decline from baseline, the date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir are documented and confirmed by a second consecutive PSA value at least 3 we | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Democratic People's Republic of, Mexico, Poland, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed