Biomarker-Guided Immunotherapy Discontinuation for Melanoma
Trial Summary
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.
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.
12345Pembrolizumab (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.
678910Nivolumab 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.
124511Eligibility Criteria
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
Trial Timeline
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
Participant Groups
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma