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Cytokine

Single arm open label for Malignant Melanoma (GIPI Trial)

Phase 2
Waitlist Available
Led By Lynn E. Spitler, M.D.
Research Sponsored by Lynn E. Spitler, MD
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 three years
Awards & highlights

Summary

The study is an open-label, single arm single Center Phase II study to evaluate the safety and efficacy of the combination of Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF, Leukine) and Ipilimumab (Yervoy) as therapy for patients with unresectable metastatic malignant melanoma.

Eligible Conditions
  • Malignant Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease control rate at 24 weeks as defined by the immune-related Response Criteria (irRC)
Secondary outcome measures
Assessment of immune activation as determined in the Companion Protocol
Duration of disease control defined as the time from the date of the first treatment dose to the date of first documentation of disease progression as defined by irRC.
Duration of objective response (CR or PR)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm open labelExperimental Treatment2 Interventions
GM-CSF and Ipilimumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
FDA approved
Ipilimumab
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,551 Previous Clinical Trials
15,257,857 Total Patients Enrolled
Lynn E. Spitler, MDLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Lynn E. Spitler, M.D.Principal InvestigatorNorthern California Melanoma Center, St. Mary's Medical Center
~2 spots leftby Sep 2025
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