Metastatic Castration-Resistant Prostate Cancer MedDRA version: 19.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 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
Product Name: Nivolumab-10 ml vial
Product Code: BMS-936558
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Nivolumab
CAS Number: 946414-94-4
Current Sponsor code: BMS-936558
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Metastatic, castrate resistant prostate cancer (M1 by NCCN criteria) -ECOG performance status 0-1 -Ongoing androgen deprivation therapy (ADT) with a GnRH analogue or a surgical/medical castration with testosterone level of =1.73nmol/L (50ng/dL) -Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ?28 days before enrollment -Bone-directed radiotherapy to pelvic region for ease of pain from painful bone metastases is allowed up to 14 days before 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 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 77
Exclusion criteria
Exclusion criteria: -Cancer that has spread to the liver or brain -Active, known, or suspected autoimmune disease or infection -Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to determine whether Nivolumab plus Ipilimumab has preliminary evidence of effectiveness in treatment of metastatic castration-resistant prostate cancer;Secondary Objective: - Assess radiographic/clinical Progression Free Survival (rcPFS) of nivolumab combined with ipilimumab followed by nivolumab monotherapy maintenance therapy until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent. - Assess overall survival (OS). - Determine the safety and tolerability of nivolumab combined with ipilimumab in subjects with metastatic castrate resistant prostate cancer. - Estimate changes in pain as measured by the Brief Pain Inventory-Short Form (BPI-SF) - 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) 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) 2/Overall Survival (OS) 3/Safety and Tolerability;Timepoint(s) of evaluation of this end point: 1/ Approximately 12 months from treatment initiation 2/ Up to 5 years from treatment initiation 3/ Approximately 12 months from treatment initiation | — |
Countries
Denmark, France, Germany, Italy, Poland, Spain, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed