Biomarker-Guided Immunotherapy Discontinuation for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial uses drugs that boost the immune system to fight advanced melanoma that can't be surgically removed. It aims to see if doctors can safely shorten the treatment period by using imaging tests to guide decisions. Pembrolizumab and ipilimumab are immunotherapy drugs used to treat advanced melanoma, with pembrolizumab approved for younger patients and ipilimumab showing positive results in previous studies.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must not be on other anti-tumor therapies besides the standard anti-PD-1 regimens. If you are on anticoagulation therapy, you may need to pause it for a biopsy procedure.
What safety data exists for pembrolizumab and other similar treatments in humans?
Pembrolizumab (Keytruda) and similar treatments like ipilimumab (Yervoy) and nivolumab (Opdivo) have been generally well-tolerated in clinical trials for melanoma, with common side effects including fatigue, rash, itching, and diarrhea. Some less common but serious immune-related side effects include inflammation of the lungs (pneumonitis), liver (hepatitis), and intestines (colitis), as well as thyroid problems.12345
How is the drug Nivolumab or Pembrolizumab unique for treating melanoma?
Nivolumab and Pembrolizumab are unique for treating melanoma because they are immune checkpoint inhibitors that help the immune system recognize and attack cancer cells. Pembrolizumab has shown better outcomes compared to ipilimumab and can lead to durable complete remission even after discontinuation, offering hope for long-term survival.678910
What data supports the effectiveness of this drug for melanoma?
Research shows that pembrolizumab works better than ipilimumab for treating advanced melanoma, and nivolumab has shown long-term survival benefits. These drugs, along with others like ipilimumab and nivolumab/ipilimumab combinations, have improved outcomes for melanoma patients, although there are differences in how long patients stay on these treatments.7891011
Who Is on the Research Team?
Geoffrey T Gibney
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults with unresectable stage IIIB-IV melanoma. Participants must have had a positive response to initial anti-PD-1 therapy, meet specific health criteria (like normal organ function tests), and not be pregnant or breastfeeding. They should not have brain metastases or other conditions that could affect the study's safety or results.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care anti-PD-1 therapy, including regimens with nivolumab, pembrolizumab, and ipilimumab, for up to 52 weeks
Evaluation and Decision
Participants are evaluated using FDG-PET/CT scans and biopsies to determine continuation or discontinuation of therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up through week 97 and then every 3 months for up to 5 years
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
- Pembrolizumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator