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

Phase 1

• Conditions: Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer; MedDRA version: 17.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002987-34-IT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-14
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 250

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified