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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02279862

2014-002987-34 (EudraCT Number)

CA184-437

Details and patient eligibility

About

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.

Full description

Prostate Cancer Clinical Trials Working Group 2 (PCWG2)

Response Evaluation Criteria In Solid Tumors (RECIST)

Enrollment: 82 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Prostate cancer with metastases
• Prostate cancer should be castration resistant
• Progression during hormonal therapy

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups

Arm 1: Ipilimumab 3 mg/kg

Experimental group

Description:

Ipilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose

Treatment:

Drug: Ipilimumab

Arm 2: Ipilimumab 10 mg/kg

Experimental group

Description:

Ipilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose

Treatment:

Drug: Ipilimumab