Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT02009384
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    administration of IV ipilimumab for up to 4 cycles

Study Details

This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.

Key Dates

Start date
Jan 31, 2012
Status verified
Oct 2021
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

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

Arms

  • Experimental: Ipilimumab
    IV ipilimumab

Primary Outcome Measure

Change From Baseline Using Immune-related Response Criteria (irRC) [ Time Frame: baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks ]

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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