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New treatment option for Metastatic Uveal Melanoma
Official title Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma
ClinicalTrials.gov ID: NCT06121180
What this study is testing
What is ZIV-Aflibercept?
ZIV-Aflibercept is an investigational medicine, being studied as a potential treatment for metastatic uveal melanoma.
Also referred to as Zaltrap, Eylea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form.
- Male or female, aged \>/= 18 years old.
- Life expectancy of greater than 3 months in the opinion of the investigator.
- Must be willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities...
- Patients must have metastatic uveal melanoma, either initial presentation or recurrent, that is histologically diagnosed.
You likely can't join if
- Pregnancy or lactation.
- Treatment with another investigational drug or other systemic intervention for uveal melanoma within 4 weeks of initiation of study drugs. Patients...
- Patients must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery and be free of significant detectable...
- Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids...
- Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive...
- Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab/placebo. NOTE...
See the full eligibility criteria
Who can join
- Provision of signed and dated informed consent form.
- Male or female, aged \>/= 18 years old.
- Life expectancy of greater than 3 months in the opinion of the investigator.
- Must be willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines.
- Patients must have metastatic uveal melanoma, either initial presentation or recurrent, that is histologically diagnosed.
- Patients with histologically or cytologically confirmed metastatic melanoma or cutaneous, mucosal or unknown primary origin are also eligible. This includes AJCC stage IV or advanced/inoperable stage III. This also...
- Patients must have ECOG performance status of 0-1.
- Patients must have measurable disease, according to RECIST version 1.1.
- Patients must have normal organ and marrow function as defined in protocol.
- Urine protein should be screened by urinalysis for Urine Protein Creatinine Ratio (UPCR). For UPCR \> 1, a 24-hour urine protein should be obtained, and the level should be \<500 mg.
- An echocardiogram should be performed at baseline in all patients. Ejection fraction (EF) from baseline echocardiogram must be within the institutional limits of normal as determined by the reading cardiologist.
- Patients on full-dose anticoagulants (e.g., warfarin) with PT INR \>1.5 are eligible provided that both of the following criteria are met:
- The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin.
- The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices).
- A patient may be treatment naïve. However, prior systemic treatments for metastatic uveal melanoma are allowed. There is no limit on the number of prior regimens for metastatic uveal melanoma. However, no prior therapy...
- Patients must be free of active brain metastasis by contrast-enhanced CT/MRI scans within 4 weeks prior to enrollment. If known to have prior brain metastases, these must have been adequately managed with standard of...
- For Women of childbearing potential: use of highly effective contraception for at least 2 or more menstrual cycles prior to screening and agreement to use such a method during study participation and for at least 180...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner For at least 1 month prior to screening and agreement to use such a method during study participation...
What rules you out
- Pregnancy or lactation.
- Treatment with another investigational drug or other systemic intervention for uveal melanoma within 4 weeks of initiation of study drugs. Patients must not have radiotherapy within the preceding 4 weeks. Patients must...
- Patients must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery and be free of significant detectable infection.
- Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e...
- Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's...
- Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab/placebo. NOTE: Patients who require brief course of steroids (eg, prophylaxis for...
- Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.
- Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug related toxicity.
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to screening/enrollment.
- History of immune related pneumonitis within the last 5 years.
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A...
- Patients with a history of solid organ transplant (patients with prior corneal transplant(s) are not excluded).
- Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible.
- Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed).
- Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration...
- Patients must not have an active infection requiring current treatment with parenteral antibiotics.
- Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina.
- Central nervous system: No history of cerebrovascular accident or transient ischemic attacks within the past 6 months.
- Serious or non-healing wound, ulcer, or bone fracture.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks of initiating study treatment.
- Patients with the following invasive procedures:
- Major surgical procedure, open biopsy or significant traumatic injury within 4 weeks of Day 1 of study therapy.
- Anticipation of need for major surgical procedures during the course of the study.
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1 of study therapy. Central venous catheter placements are permitted to be completed 7 or more days prior to Day 1 of study...
- Patients with clinically significant cardiovascular or cerebrovascular disease:
- History of cerebrovascular accident or transient ischemic attack within past 6 months
- Uncontrolled hypertension, defined as blood pressure \>150/100 mm Hg or systolic BP \>180 mm Hg if diastolic blood pressure \<90 mm Hg, on at least 2 repeated determinations on separate days within past 3 months.
- Myocardial infarction, coronary artery bypass grafting (CABG) or unstable angina within the past 6 Months.
- New York Heart Association grade III or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris within past 6 months.
- Clinically significant peripheral vascular disease within past 6 months.
- Pulmonary embolism, deep vein thrombosis (DVT), or other thromboembolic event within past 6 months.
- History of tumor-related or other serious hemorrhage, bleeding diathesis, or underlying coagulopathy.
- PT INR \>1.5 unless the patient is on full-dose warfarin.
- Patients who have other current malignancies are not eligible. Patients with other malignancies are eligible if they have been continuously disease free for \> 3 years prior to the time of enrollment. Patients with...
- Receipt of a live vaccine within 28 days of the enrollment date.
- Women of childbearing potential or sexually active men, who are unwilling to practice highly effective contraception for at least 2 or more menstrual cycles (women) or 1 month (men) prior to screening, during the study...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- New Hyde Park, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Tampa, Florida, United States; Chicago, Illinois, United States; New Hyde Park, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.