Actively Recruiting
IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
29
Participants Needed
1
Research Sites
475 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
C
Clinigen, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic melanoma (stage IV or inoperable stage III)
- Measurable disease according to RECIST version 1.1
- No active brain metastasis by recent CT or MRI scans
- Prior anti-PD1 immunotherapy (nivolumab or pembrolizumab) with disease progression
- No systemic therapy or radiotherapy within 3 weeks before enrollment
- At least 4 weeks since major surgery and fully recovered
- Prior anti-CTLA4 therapy is allowed
- Patients with prior high-grade immune-related adverse events must be cleared by study PI
- For BRAF V600 mutant melanoma, prior BRAF targeted therapy with progression or intolerance
- Life expectancy greater than 3 months
- ECOG performance status 0 or 1
- Normal organ and marrow function per protocol
- Stable full-dose anticoagulant use with INR in range and no active bleeding
- Pulmonary function (FEV1) greater than 2.0 liters or 75% predicted
- No congestive heart failure or serious cardiac conditions
- Negative or low probability cardiac stress test for those over 40 or with cardiac history
- No cerebrovascular accident or transient ischemic attacks in past 6 months
- Use of contraception for women of child-bearing potential and men during and 6 months after study
- Negative pregnancy test for women of childbearing age within 2 weeks of enrollment
- Women should not be lactating
You will not qualify if you...
- Systemic therapy or radiotherapy within 3 weeks prior to study or incomplete recovery from prior adverse events
- Active brain metastasis
- Clinically significant cardiovascular or cerebrovascular disease
- Uncontrolled illness including active infection or psychiatric/social issues limiting compliance
- Current malignancies except those disease-free for over 2 years or certain in situ cancers
- Autoimmune disorders or immunosuppression requiring ongoing systemic corticosteroids or immunosuppressants
- Adrenal insufficiency
- Use of other investigational agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
A
Arnay Marshall
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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