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Advanced Melanoma Patients with Immune Checkpoint Inhibitors for Melanoma

N/A
Recruiting
Led By Vincent Ma, MD
Research Sponsored by University of Wisconsin, Madison
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 baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
Awards & highlights

Study Summary

The purpose of this research study is to determine if analysis of PET/CT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.

Eligible Conditions
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3-4 weeks after start of therapy (up to 5 weeks on study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapy
Change in ctDNA level from baseline to 3-4 week after the start of therapy
Correlation between ctDNA level change and 18F-FDG PET/CT response from baseline to 3-4 week after the start of therapy
+1 more
Secondary outcome measures
Change in Standard Uptake Value (SUV) metrics with onset of Immune Related Adverse Events (irAE)
Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and OS
Correlation Coefficient for 18F-FDG PET/CT response at 3-4 weeks after the start of therapy and PFS
+6 more

Side effects data

From 2015 Phase 2 trial • 59 Patients • NCT01146054
29%
Anemia
29%
Lymphocyte count decreased
27%
Anorexia
27%
Fatigue
24%
Abdominal Pain
12%
Nausea
10%
Platelet Count Decreased
8%
Dyspepsia
6%
Constipation
2%
Duodenal hemorrhage
2%
Duodenal Ulcer
2%
Dehydration
2%
Sepsis
2%
Duodenal Fistula
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT and Gemzar

Trial Design

1Treatment groups
Experimental Treatment
Group I: Advanced Melanoma Patients with Immune Checkpoint InhibitorsExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,563 Total Patients Enrolled
9 Trials studying Melanoma
313 Patients Enrolled for Melanoma
Vincent Ma, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients
2024. "Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06199713.
All > Milwaukee
~16 spots leftby Jan 2026
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