Actively Recruiting
A Phase II Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-12-04
32
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
G
Genzyme, a Sanofi Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying metastatic uveal melanoma, a type of cancer that has spread to other parts of the body. This clinical research aims to evaluate if combining the drugs Cemiplimab and Ziv-Aflibercept is safe and effective in shrinking tumors or stopping their growth in people with this condition. The study is a phase II trial sponsored by the H. Lee Moffitt Cancer Center and Research Institute, focusing on advanced melanoma cases that may have progressed despite prior therapies. Participants will receive Cemiplimab at a dose of 350 mg intravenously every three weeks, alongside Ziv-Aflibercept at 4 mg/kg intravenously every two weeks. The treatment cycles last three weeks, with these drugs given in combination throughout the study period. This investigational approach tests how blocking certain immune and blood vessel pathways may affect tumor control in metastatic uveal melanoma. During the study, participants will be closely monitored with regular assessments to measure tumor response using standardized criteria. Researchers will track outcomes such as the objective response rate, progression-free survival, and overall survival over a period of five years. Safety evaluations and ongoing health status checks will be part of the follow-up to understand the impact of the treatment combination on patients' disease and wellbeing.
CONDITIONS
Brief Title
Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form provided.
- Male or female aged 18 years or older.
- Life expectancy greater than 3 months as judged by the investigator.
- Histologically diagnosed metastatic uveal melanoma or histologically/cytologically confirmed metastatic melanoma of cutaneous, mucosal, or unknown primary origin.
- Previous anti-PD1 immunotherapy or BRAF targeted therapy for metastatic melanoma with subsequent disease progression, or treatment-nafve.
- ECOG performance status of 0-1.
- Measurable disease according to RECIST version 1.1.
- Normal organ and marrow function as defined in protocol.
- Urine protein screening with UPCR 1 or 24-hour urine protein <500 mg if UPCR >1.
- Baseline echocardiogram with ejection fraction within normal institutional limits.
- Stable full-dose anticoagulant use allowed with specified INR criteria and no high-risk bleeding.
- No prior therapy with bevacizumab, aflibercept, or cemiplimab.
- Free of active brain metastasis by CT/MRI within 4 weeks prior to enrollment or adequately managed prior brain metastases.
- Effective contraception use for women of childbearing potential and men of reproductive potential during and after study.
You will not qualify if you...
- Pregnancy or lactation.
- Treatment with other investigational drugs or systemic interventions for uveal melanoma within 4 weeks.
- Radiotherapy within the preceding 4 weeks.
- Recovery not complete from adverse events of previous treatments given more than 4 weeks earlier.
- Less than 4 weeks from major surgery or unresolved surgical effects.
- Autoimmune disorders or immunosuppression requiring ongoing systemic corticosteroids or immunosuppressants.
- History of symptomatic autoimmune diseases such as rheumatoid arthritis, lupus, or multiple sclerosis.
- Use of immunosuppressive corticosteroids >10 mg prednisone daily within 4 weeks before study start.
- Prior allogeneic or autologous stem cell transplantation.
- Discontinuation of anti-cancer immune therapies due to toxicity.
- Recent encephalitis, meningitis, uncontrolled seizures within 1 year.
- History of immune-related pneumonitis in past 5 years.
- Interstitial lung disease or active pneumonitis requiring glucocorticoids.
- History of solid organ transplant (except corneal transplant).
- Inflammatory bowel disease or diverticulitis.
- Significant medical, surgical, or psychiatric conditions interfering with study compliance.
- Active infection needing parenteral antibiotics.
- Significant cardiac or cerebrovascular disease including recent myocardial infarction, unstable angina, or congestive heart failure.
- Serious or non-healing wounds, ulcers, or fractures.
- Recent major surgery, biopsy, or traumatic injury within 4 weeks.
- Clinically significant cardiovascular or cerebrovascular disease within 6 months.
- History of serious bleeding disorders or coagulopathy.
- PT INR >1.5 unless on full-dose warfarin.
- Other current malignancies unless disease free for more than 3 years.
- Receipt of live vaccine within 28 days before enrollment.
- Unwillingness to practice effective contraception during and after study participation.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive Cemiplimab and Ziv-Aflibercept administered intravenously in repeated 3-week cycles to treat metastatic uveal melanoma.
Cemiplimab given every 3 weeks and Ziv-Aflibercept given every 2 weeks with visits accordingly
Trial Site Locations
Total: 4 locations
1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Northwell Health Center for Advanced Medicine
New Hyde Park, New York, United States, 11042
Actively Recruiting
Research Team
I
Indra Herron
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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