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Ipilimumab and GMCSF Immunotherapy for Prostate Cancer

NCT01530984 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-10-05

No results posted yet for this study

Summary

This is an open-label randomized phase II study. Patients are randomized so as to achieve uniform patient cohorts treated on each regimen. Twenty-seven patients will be required per treatment arm, and a total of 54 prostate cancer patients will be required to complete this study. The study will assess for clinical activity by Prostate Specific Antigen (PSA) response, of both single agent ipilimumab and the combination of GM-CSF and ipilimumab in chemotherapy-naïve patients with metastatic castrate resistant prostate cancer.

Conditions

Interventions

DRUG

Ipilimumab

Ipilimumab 3 mg/kg on day 1 of a 28 day cycle for 6 cycles.

DRUG

GM-CSF

GM-CSF 250 mcg/m2 SQ on days 1-14 for 6 cycles.

Sponsors & Collaborators

Principal Investigators

  • Lawrence Fong, MD · University of California, San Francisco

  • Lawrence Fong, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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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 NCT01530984 on ClinicalTrials.gov