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Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

NCT01057810 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 837

Last updated 2016-08-18

Study results available
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Summary

The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

Conditions

Interventions

DRUG

Ipilimumab

5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure

DRUG

Placebo

Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2015-04-30
Completion
2015-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Puerto Rico
  • Romania
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01057810 on ClinicalTrials.gov