A Phase II Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 includes patients with a history of lower stage melanoma and subsequent recurrent metastatic disease that is either locally/regionally advanced/inoperable disease or distant metastases. These patients must have previously received anti-PD1 immunotherapy (nivolumab or pembrolizumab) as monotherapy or in combination and later experienced disease progression. Patients with BRAF V600 mutant melanoma must have previously received BRAF targeted therapy for metastatic melanoma and later experienced disease progression. Patients who refuse or decline to receive BRAF targeted therapy or prefer to delay or were intolerant of BRAF targeted therapy are eligible

• 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 with bevacizumab, aflibercept or cemiplimab.

• 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 care radiation therapy, stereotactic radiosurgery or surgery prior to registration on the study.

• 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 days after the end of study drugs administration.

• 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 and for at least 180 days after the end of study drugs administration.

Locations
United States
California
The Angeles Clinic and Research Institute
RECRUITING
Los Angeles
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
New York
Northwell Health Center for Advanced Medicine
RECRUITING
New Hyde Park
Contact Information
Primary
Malik Hall
Malik.Hall@moffitt.org
813-745-5170
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2030-10-31
Participants
Target number of participants: 32
Treatments
Experimental: Cemiplimab + Ziv-Aflibercept
One cycle consists of 3 weeks during which:~Cemiplimab 350 mg administered IV every 3 weeks given with Ziv-Aflibercept 4 mg/kg administered IV every 2 weeks.
Sponsors
Collaborators: Regeneron Pharmaceuticals, Genzyme, a Sanofi Company
Leads: H. Lee Moffitt Cancer Center and Research Institute

This content was sourced from clinicaltrials.gov