Actively Recruiting
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
312 weeks
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
The goal of this clinical research study is to find out if Cemiplimab plus Ziv-Aflibercept is safe and effective in treating your condition of metastatic (spread to other parts of your body) uveal melanoma. This research study will test the study drugs to see if the combination of Cemiplimab plus Ziv-Aflibercept can make tumors shrink or stop growing.
CONDITIONS
Official Title
Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Male or female aged 18 years or older.
- Life expectancy greater than 3 months.
- Ability to provide informed consent or have a legally acceptable representative provide consent.
- Histologically diagnosed metastatic uveal melanoma, initial or recurrent.
- Patients with confirmed metastatic melanoma of cutaneous, mucosal, or unknown primary origin who have received prior anti-PD1 immunotherapy or BRAF targeted therapy and experienced progression.
- ECOG performance status of 0-1.
- Measurable disease according to RECIST version 1.1.
- Normal organ and marrow function as defined by protocol.
- Urine protein screening with acceptable levels (UPCR ≤1 or 24-hour protein <500 mg).
- Baseline echocardiogram with normal ejection fraction.
- Patients on stable full-dose anticoagulants with INR ≤1.5 and no active bleeding risk.
- May be treatment naive or have prior systemic treatments for metastatic uveal melanoma except prior therapy with bevacizumab, aflibercept, or cemiplimab.
- Free of active brain metastasis or adequately managed prior brain metastases.
- Women of childbearing potential must use highly effective contraception before and during the study and for 180 days after treatment.
- Males of reproductive potential must use effective contraception before and during the study and for 180 days after treatment.
You will not qualify if you...
- Pregnancy or breastfeeding.
- Treatment with another investigational drug or systemic intervention for uveal melanoma within 4 weeks before study drugs.
- Radiotherapy within 4 weeks before study drugs.
- Recovery not complete from adverse events of prior treatments.
- Major surgery within 4 weeks before study or not fully recovered.
- Autoimmune disorders or immunosuppressive conditions requiring 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 first dose.
- Prior allogeneic or autologous stem cell transplantation.
- Permanent discontinuation of immune modulating therapies due to toxicity.
- Encephalitis, meningitis, or uncontrolled seizures within one year before enrollment.
- History of immune-related pneumonitis within last 5 years.
- History of interstitial lung disease or active noninfectious pneumonitis requiring glucocorticoids.
- History of solid organ transplant (except corneal transplant).
- History of inflammatory bowel disease or diverticulitis.
- Significant medical, surgical, or psychiatric conditions affecting study compliance or safety.
- Active infection requiring parenteral antibiotics.
- Significant cardiac or cerebrovascular disease including recent myocardial infarction, unstable angina, heart failure, arrhythmias, or stroke.
- Serious or non-healing wounds, ulcers, or fractures.
- Recent abdominal fistula, gastrointestinal perforation, or abscess within 4 weeks.
- Recent major surgical procedures or significant injuries within 4 weeks.
- Anticipation of major surgery during study.
- Minor surgeries or biopsies within 7 days before study therapy.
- Clinically significant hypertension not controlled within past 3 months.
- History of serious bleeding or coagulopathy.
- PT INR >1.5 unless on full-dose warfarin.
- Other current malignancies unless disease-free for over 3 years.
- Receipt of a live vaccine within 28 days before enrollment.
- Unwillingness to use highly effective contraception as required during and after the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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