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

Part of paid clinical trials in Los Angeles, California.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06121180
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZIV-Aflibercept — DRUG
    Ziv-Aflibercept is an investigational or experimental anti-cancer agent inactivates vascular endothelial growth factor (VEGF) from functioning and scientific experiments have shown that when VEGF is prevented from working, new blood vessels don't form in tumors and these tumors do not grow. In addition, VEGF has been shown to have a negative effect on the immune response and blocking it may help the immune response against cancer.
  • Cemiplimab — DRUG
    Cemiplimab is a human monoclonal anti-PD-1 antibody that works by blocking the programmed death-1 (PD-1), a cell receptor on immune cells that is involved in preventing immune cells from destroying other cells. Blocking the receptor is expected to help immune cells attack cancer cells.

Study Details

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.

Key Dates

Start date
Nov 4, 2024
Status verified
Dec 2025
Primary completion
Oct 31, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: 5 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025
Inderjit Mehmi, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Indra Herron
[email protected]
813-745-4482
Ahmad Tarhini, MD, PHD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois60637
Daniel Olson, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health Center for Advanced MedicineNew Hyde ParkNew York11042
Shaheer Khan, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic and Research Institute· Los Angeles, CAMoffitt Cancer Center· Tampa, FLUniversity of Chicago Medical Center· Chicago, ILNorthwell Health Center for Advanced Medicine· New Hyde Park, NY

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