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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02279862

Run by

Bristol-Myers Squibb

People needed

82

Starts

2014-12-02

Expected to finish

2016-12-15

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• San Francisco Oncology Associates — San Francisco, California, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Cancer Center Of Kansas — Wichita, Kansas, United States
• North Mississippi Med Center — Tupelo, Mississippi, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Northwest Cancer Specialists, Pc — Tualatin, Oregon, United States
• University of Pittsburgh Cancer Institute Cancer Services — Pittsburgh, Pennsylvania, United States
• Texas Oncology — Houston, Texas, United States
• Virginia Cancer Institute — Richmond, Virginia, United States
• Local Institution — St Leonards, New South Wales, Australia
• Local Institution — Wahroonga, New South Wales, Australia
• Local Institution — Parkville, Victoria, Australia
• Local Institution — Recoleta, Santiago de Chile, Chile
• Local Institution — Santiago, Santiago Metropolitan, Chile
• Local Institution — Viña del Mar, Valparaiso, Chile
• Local Institution — Clermont-Ferrand, France
• Local Institution — Marseille, France
• Local Institution — Poitiers, France
• Local Institution — Rennes, France
• Local Institution — Saint-Herblain, France
• Local Institution — Villejuif, France
• Universitaetsklinikum Aachen — Aachen, Germany
• Uniklinik Heidelberg — Heidelberg, Germany

Full record on ClinicalTrials.gov

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