Safety and Efficacy study of ipilimumab 3 mg/kg versus ipilimumab 10 mg/kg in subjects with metastatic castration resistant prostate cancer who are chemotherapy naive

A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic Pharmacogenetics Blood Sample Amendment Number 01

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002987-34-DE

Enrollment

250

Registered

2014-09-22

Start date

2014-12-22

Completion date

Unknown

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer MedDRA version: 17.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Ipilimumab Product Code: BMS-734016 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IPILIMUMAB CAS Number: 477202-00-9 Current Sponsor code: BMS-734016 /

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Prostate cancer with metastases - Prostate cancer should be castration resistant - Progression during hormonal therapy Please see protocol for further information on inclusion criteria 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 175

Exclusion criteria

Exclusion criteria: - Visceral metastases (eg liver, lung or brain metastases) - Prior treatment with any immunotherapy for prostate cancer - Prior or ongoing cytotoxic therapy for prostate cancer - Autoimmune disease - Inadequate hematologic, renal, or hepatic function Please see protocol for further information on exclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses ( 3 mg/kg and 10 mg/kg) of ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer;Secondary Objective: - To assess the rate of severe irAEs - To assess overall survival - To assess PSA PFS - To assess PSA response - To assess time to pain progression;Timepoint(s) of evaluation of this end point: approximately 12 months;Primary end point(s): Radiologic Progression Free Survival: Radiographic PFS (rPFS) is defined as the time from randomization to the earliest date on which either of the following events was documented: radiographic progression (per PCWG2 for bone lesions and modified RECIST 1.1 for non-bone lesions) or death. All radiological progression will be based on investigator assessments.	—

Measure

Time frame

Main Objective: The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses ( 3 mg/kg and 10 mg/kg) of ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer;Secondary Objective: - To assess the rate of severe irAEs - To assess overall survival - To assess PSA PFS - To assess PSA response - To assess time to pain progression;Timepoint(s) of evaluation of this end point: approximately 12 months;Primary end point(s): Radiologic Progression Free Survival: Radiographic PFS (rPFS) is defined as the time from randomization to the earliest date on which either of the following events was documented: radiographic progression (per PCWG2 for bone lesions and modified RECIST 1.1 for non-bone lesions) or death. All radiological progression will be based on investigator assessments.

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Secondary

Measure	Time frame
Secondary end point(s): Rate of severe immune-related adverse events, Overall survival, Prostate Specific Antigen Progression-free Survival, Prostate Specific Antigen Response Rate, Time to Pain Progression;Timepoint(s) of evaluation of this end point: approximately 36 months	—

Countries

Argentina, Australia, Chile, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, United Kingdom

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026