FDG PET/CT for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to predict how well individuals with advanced melanoma (a type of skin cancer that has spread) will respond to immunotherapy treatment. Researchers will use PET/CT scans and blood tests to identify those who might experience better outcomes or side effects. It suits individuals diagnosed with stage III or IV melanoma who plan to receive immunotherapy. Participants will engage in the study for about four weeks after starting this treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in melanoma care.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have used investigational drugs, biologics, or devices within 30 days before enrolling.
What prior data suggests that PET/CT scan analysis and blood testing are safe for melanoma patients?
Research has shown that immune checkpoint inhibitors (ICIs) have greatly improved the treatment of advanced melanoma. These drugs significantly increase survival rates and often lead to long-lasting improvements. However, they can cause side effects, known as immune-related adverse events, which vary depending on the specific drug and dose.
A review of studies found that while these side effects can occur, many patients tolerate the treatment well. Common side effects include tiredness, skin rash, and diarrhea. Serious side effects are less common but can affect the liver, lungs, or other organs. Despite these risks, ICIs are generally considered safe for treating melanoma, especially when weighing the potential benefits.12345Why are researchers excited about this trial?
Unlike the standard treatments for melanoma, which typically involve various immune checkpoint inhibitors, this investigation focuses on the potential of early FDG PET/CT scans and circulating tumor DNA (ctDNA) as tools for monitoring treatment response in patients. Researchers are excited because these methods could allow for quicker, more precise assessments of how well a treatment is working, potentially leading to faster adjustments in therapy. This approach could revolutionize personalized treatment plans, making them more effective and reducing unnecessary exposure to ineffective treatments.
What evidence suggests that this trial's methods could be effective for melanoma?
Research has shown that immune checkpoint inhibitors (ICIs) effectively treat advanced melanoma. In this trial, participants will receive ICIs as part of their treatment. Studies have found that about half of the patients with metastatic melanoma live cancer-free for 10 years or more when treated with these drugs. Using a combination of ICIs, which involves taking more than one type of these drugs, has yielded better results, with 52.2% of patients responding well to treatment compared to using just one drug. Additionally, these treatments have been linked to nearly a 50% survival rate for people with advanced melanoma over several years. These findings highlight the potential of ICIs to improve long-term outcomes for melanoma patients.678910
Who Is on the Research Team?
Vincent Ma, MD
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment and Assessment
Participants receive initial ICI therapy and undergo baseline and early interval 18F-FDG PET/CT imaging to assess response and correlate with ctDNA levels
Follow-up
Participants are monitored for safety, clinical response, and survival outcomes, including PFS and OS, with periodic assessments
What Are the Treatments Tested in This Trial?
Interventions
- 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Citations
Comparative Meta-Analysis of Survival, Risk, and ...
Results: Compared to monotherapy, combination immunotherapy achieved higher clinical benefit, with an overall response of 52.2% (vs. 31.6%), a ...
2.
dana-farber.org
dana-farber.org/newsroom/news-releases/2024/long-term-metastatic-melanoma-survival-dramatically-improves-on-immunotherapyLong-term Metastatic Melanoma Survival Dramatically ...
Half of patients with metastatic melanoma treated with a combination of immune checkpoint inhibitors survive cancer-free for 10 years or more.
Efficacy of immune checkpoint inhibitors in advanced ...
Combination anti-CTLA-4 and anti-PD-1 therapy resulted in modestly superior ORR, median OS and PFS outcomes at 31.9%, 19.1 months and 5.0 months ...
When to stop immunotherapy for advanced melanoma
Immune checkpoint inhibitors (ICIs) have demonstrated their efficacy with a 7.5-year overall survival (OS) close to 50% for advanced stages.
10-Year Data Underscore How ICI Therapy Has Helped to ...
The final, 10-year results of the CheckMate 067 study continue to show long-term survival benefit with nivolumab plus ipilimumab and with nivolumab monotherapy.
Real‑world efficacy and safety data of immune checkpoint ...
Real‐world efficacy and safety data of immune checkpoint inhibitors in Turkish patients with metastatic melanoma: A Turkish oncology group retrospective study
Systematic review and meta-analysis efficacy and safety of ...
Systematic review and meta-analysis efficacy and safety of immune checkpoint inhibitors in advanced melanoma patients with anti-PD-1 progression ...
Targeting Immune Checkpoint Pathways in Melanoma
The immune checkpoint inhibitors (ICIs) have revolutionized the treatment of advanced melanoma by significantly increasing survival rates.
Immune Checkpoint Inhibitors and Immune-Related ...
The risk of immune-related adverse events varied by the immune checkpoint inhibitors used and by the different doses of these same immune checkpoint inhibitors.
Efficacy and safety of immune checkpoint inhibitors in ...
The integration of immune checkpoint inhibitors (ICI) for the treatment of melanoma has resulted in remarkable and durable responses.
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