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Cytokine
A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients
Phase 1 & 2
Waitlist Available
Led By Jason Chesney, MD, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Skin Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ipilimumab and GM-CSFExperimental Treatment2 Interventions
IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2015
Completed Phase 3
~3420
GM-CSF
2011
Completed Phase 4
~1280
Find a Location
Who is running the clinical trial?
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,169 Total Patients Enrolled
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,351 Total Patients Enrolled
Jason Chesney, MD, PhDPrincipal InvestigatorUniversity of Louisville
3 Previous Clinical Trials
134 Total Patients Enrolled