Nivolumab + Ipilimumab for Melanoma
Trial Summary
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you must stop them at least 14 days before starting the trial treatment.
What data supports the effectiveness of the drug combination Nivolumab and Ipilimumab for treating melanoma?
Is the combination of Nivolumab and Ipilimumab safe for treating melanoma?
The combination of Nivolumab and Ipilimumab for melanoma can lead to increased risk of immune-related side effects, which can be more frequent and severe than when using each drug alone. Common side effects include fatigue, diarrhea, and skin reactions, but most are reversible with treatment. Close monitoring by experienced healthcare providers is important to manage these side effects effectively.678910
How is the drug Nivolumab + Ipilimumab unique for treating melanoma?
Nivolumab and ipilimumab work together to boost the immune system's ability to fight melanoma by targeting different pathways, leading to better response rates and longer survival compared to using ipilimumab alone. This combination is unique because it uses two different types of immune checkpoint inhibitors to enhance the body's natural defenses against cancer.2341112
What is the purpose of this trial?
Effective adjuvant treatment can increase cure in patients with high-risk resected melanoma. High dose interferon is a standard of care in the adjuvant setting but is highly toxic and marginally effective. The combination of ipilimumab and nivolumab is the most active regimen in patients with advanced melanoma so there is clear rationale to test this regimen in the adjuvant setting. Investigators are testing if nivolumab 3mg/kg every 2 weeks with 1mg/kg ipilimumab every 6 weeks in the high risk adjuvant setting. The duration of therapy will be six months.
Research Team
Howard Safran, MD
Principal Investigator
BrUOG Study Chair
Eligibility Criteria
Adults over 18 with high-risk melanoma that's been surgically removed can join. They should be healthy enough for treatment (ECOG 0-1), not have had other cancer treatments except surgery or radiation, and must agree to use birth control. People with certain medical conditions, previous immunotherapy, active infections like hepatitis B/C or HIV, pregnant/breastfeeding women, and those with brain metastases cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab 3mg/kg every 2 weeks and ipilimumab 1mg/kg every 6 weeks for a total of 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab
- Nivolumab
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maria Constantinou
Lead Sponsor
Brown University
Lead Sponsor
Rhode Island Hospital
Collaborator
The Miriam Hospital
Collaborator