Ipilimumab and GMCSF Immunotherapy for Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Lawrence Fong
Study ID
NCT01530984
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab 3 mg/kg on day 1 of a 28 day cycle for 6 cycles.
  • GM-CSF — DRUG
    GM-CSF 250 mcg/m2 SQ on days 1-14 for 6 cycles.

Study Details

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.

Key Dates

Start date
Jun 30, 2015
Status verified
Oct 2015
Primary completion
Dec 31, 2017
Completion
Dec 31, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab alone
    Ipilimumab 3 mg/kg (IV) will be given every 28 days for six cycles (induction) followed by administration once every three months for patients who are not progressing (maintenance).
  • Experimental: Ipilimumab with GM-CSF
    Ipilimumab 3 mg/kg (IV) will be given every 28 days for six cycles (induction) followed by administration once every three months for patients who are not progressing (maintenance). GM-CSF 250 mcg/m2 SQ will be administered on days 1-14 in Cycles 1-6 and then every 3 months for 14 days beginning on the day of ipilimumab administration during the maintenance therapy phase

Primary Outcome Measure

To assess for clinical activity by 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. [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California· San Francisco, CA

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