IL2 + Ipilimumab and Nivolumab for Melanoma
Trial Summary
What is the purpose of this trial?
The purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you must not have had systemic therapy or radiotherapy within 3 weeks before joining. If you are on steroids, you need to stop them at least 2 weeks before starting the trial.
What data supports the effectiveness of the drug combination IL2, Ipilimumab, and Nivolumab for treating melanoma?
Research shows that IL-2 can induce durable responses in some melanoma patients, and the combination of Ipilimumab and Nivolumab has been effective in improving survival in advanced melanoma. Additionally, adding IL-2 to Ipilimumab and Nivolumab has shown promise in overcoming resistance in some cancer treatments, suggesting potential benefits for melanoma.12345
What safety data exists for the combination of IL2, Ipilimumab, and Nivolumab in humans?
What makes the IL2 + Ipilimumab and Nivolumab treatment unique for melanoma?
This treatment combines three drugs that work together to boost the immune system's ability to fight melanoma. Interleukin-2 (IL-2) helps grow immune cells, while Ipilimumab and Nivolumab block proteins that stop the immune system from attacking cancer cells, making this combination a novel approach compared to using each drug alone.111121314
Research Team
Ahmad Tarhini, MD, PhD
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
This trial is for adults with advanced melanoma who have had prior anti-PD1 immunotherapy but their disease got worse. They must be in good health otherwise, not have serious heart issues or brain metastasis, and agree to use contraception. It's not for those with autoimmune diseases on steroids, other cancers (unless free of disease for over 2 years), or recent treatments that they haven't recovered from.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive high dose bolus IL2 in combination with low dose ipilimumab followed by nivolumab for up to 3 courses
Response Assessment
Response assessment occurs at the end of the 4th cycle of each course
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Interleukin-2
- Ipilimumab
- Nivolumab
Interleukin-2 is already approved in United States, European Union for the following indications:
- Metastatic melanoma
- Metastatic renal cell carcinoma
- Metastatic renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Clinigen, Inc.
Industry Sponsor