IL-2 + Nivolumab for Melanoma
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot be on high-dose systemic steroids or immunosuppressive medications, and you must not have taken any investigational agents within 21 days before starting the trial. Please discuss your specific medications with the trial team.
What data supports the idea that IL-2 + Nivolumab for Melanoma is an effective treatment?
The available research shows that combining IL-2 with Nivolumab can be effective for treating melanoma. In particular, a study found that adding bempegaldesleukin (a form of IL-2) to Nivolumab improved responses in patients with metastatic melanoma, with 20 out of 38 patients showing positive results. This combination was also well-tolerated, meaning it didn't cause many side effects. Additionally, another study compared this combination to Nivolumab alone and found it to be more effective in preventing the return of melanoma after surgery. These findings suggest that IL-2 combined with Nivolumab can be a promising treatment option for melanoma.12345
What safety data exists for IL-2 and Nivolumab treatment in melanoma?
Safety data for IL-2 (Aldesleukin) and Nivolumab (Opdivo) in melanoma includes reports of immune-related adverse events (irAEs) such as pneumonitis, hypothyroidism, dermatitis, enterocolitis, hepatitis, and neuropathy associated with Nivolumab. IL-2 has been associated with severe adverse events, particularly with the original intravenous bolus regimen, which often requires intensive care. However, continuous intravenous infusion and subcutaneous administration have reduced the severity of these adverse events. The combination of Bempegaldesleukin (a modified IL-2) and Nivolumab was well-tolerated in early trials, with further safety assessments ongoing in a Phase III trial. Overall, while both treatments have shown efficacy, their risk/benefit profiles require careful consideration due to potential toxicities.12678
Is the drug IL-2 and Nivolumab a promising treatment for melanoma?
Yes, IL-2 and Nivolumab show promise as a treatment for melanoma. IL-2 can lead to long-lasting responses in melanoma patients by boosting the immune system. Nivolumab, which helps the immune system attack cancer cells, has been shown to improve survival in advanced melanoma. Together, they have demonstrated clinical activity and potential for effective treatment.135910
What is the purpose of this trial?
The primary objective of this single arm phase 2 trial is to assess the response rate \[complete response (CR) + partial response (PR)\] of combined nivolumab and HD IL-2 in subjects with metastatic melanoma and renal cell carcinoma. Response will be performed after each course of nivolumab and IL-2 using RECIST 1.1. Patients will be treated for one course past best response for a maximum of 3 courses.
Eligibility Criteria
Adults with metastatic melanoma or renal cell carcinoma who've previously tried anti-PD-1 therapy without success. They must be in good physical condition, not pregnant, willing to use birth control, and have recovered from previous treatments' side effects. Exclusions include active infections, other recent cancers (except certain localized ones), uncontrolled hypertension, mental conditions preventing consent, and certain medical histories like autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combined therapy with nivolumab and high dose IL-2 for up to 3 courses, with response assessments after each course
Follow-up
Participants are monitored for safety, effectiveness, and progression-free survival after treatment
Treatment Details
Interventions
- IL-2
- Nivolumab
IL-2 is already approved in United States, European Union for the following indications:
- Renal cell carcinoma
- Melanoma
- Renal cell carcinoma
- Melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gregory Daniels
Lead Sponsor