Metastatic Castration-Resistant Prostate Cancer 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: 21.1 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: Yervoy (200mg/40ml)
Product Name: Ipilimumab
Product Code: BMS-734016
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IPILIMUMAB
CAS Number: 477202-00-9
Cur
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - ECOG performance status 0-1 - Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI). - Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of =1.73nmol/L (50ng/dL). For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: - Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization 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 154 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 335
Exclusion criteria
Exclusion criteria: - Presence of visceral metastases in the liver - Active brain metastases or leptomeningeal metastases - Active, known, or suspected autoimmune disease or infection - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: - Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab. - Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evaluate objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 assessed by Blinded Independent Central Review (BICR) in subjects with mCRPC and measurable disease at baseline. - Assess Radiographic Progression Free Survival (rPFS) assessed by BICR in all treated subjects with mCRPC using RECIST V1.1 for soft tissue disease progression and PCWG2 for bone disease progression.;Secondary Objective: - Assess radiographic/clinical Progression Free Survival (rcPFS) - Assess overall survival (OS). - Evaluate PSA response rate (PSA-RR) - Determine the safety and tolerability in all treated subjects . - Estimate changes in pain as measured by the Brief Pain Inventory-Short Form (BPI-SF) - Estimate changes in cancer-related symptoms and quality of life (QoL) using the FACT-P questionnaire - Estimate changes in health status and health utility as measured by the 3-level EQ-5D-3L questionnaire;Primary end point(s): 1/Objective Response Rate (ORR) in Cohort B, C, and Cohort D 2/Radiographic Progression-Free Survival (rPFS) ;Timepoint(s) of evaluation of this end point: 1/ Approximately 24 weeks from treatment initiation 2/ Approximately 12 months from treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C 2/Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D 3/Overall Survival (OS) in Cohort B, C 4/Overall Survival (OS) in Cohort D 5/Incidence of Adverse Events (AEs) 6/Incidence of Serious Adverse Events (SAEs) 7/Incidence of Adverse Events (AEs) leading to discontinuation 8/Incidence of Immune-mediated Adverse Events (IMAEs) 9/Incidence of deaths 10/Incidence of laboratory abnormalities: Hematology, Clinical Chemistry, Coagulation, Liver function, Thyroid function, Adrenal function, Renal function 11/Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF) 12/Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L) 13/Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire 14/Prostate Specfic Antigen (PSA) Response Rate ;Timepoint(s) of evaluation of this end point: 1/ Approximately 12 months from treatment initiation 2/ Approximately 12 months from randomization 3/ Up to 5 years from treatment initiation 4/ Up to 5 years from randomization 5-10/From first dose up to and including 100 days post last dose 11/ Approximately 12 months from treatment initiation 12/ Approximately 12 months from treatment initiation 13/ Approximately 24 months from treatment initiation 14/ Up to 24 weeks from treatment initiation | — |
Countries
Australia, Austria, Canada, Denmark, France, Germany, Italy, Poland, Spain, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed