A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT02009397
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.

Key Dates

Start date
Feb 29, 2012
Status verified
Oct 2021
Primary completion
Nov 30, 2016
Completion
Nov 30, 2016

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab and GM-CSF
    IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles

Primary Outcome Measure

Change in Immune-related Overall Response Rate (irORR) [ Time Frame: assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab ]

Locations (1)

FacilityCityStateZIPSite coordinators
James Graham Brown Cancer CenterLouisvilleKentucky40202-

Find similar trials in Louisville, KY

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
James Graham Brown Cancer Center· Louisville, KY

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