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Checkpoint Inhibitor

Cemiplimab + Ziv-Aflibercept for Uveal Melanoma

Phase 2

Recruiting

Led By Ahmad Tarhini, MD, PHD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have ECOG performance status of 0-1

Patients must have metastatic uveal melanoma, either initial presentation or recurrent, that is histologically diagnosed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will test if Cemiplimab+Ziv-Aflibercept can shrink/stop growth of metastatic uveal melanoma tumors.

Who is the study for?

Adults with metastatic uveal melanoma can join this trial. They should have a life expectancy over 3 months, an ECOG performance status of 0-1 (fully active or restricted in physically strenuous activity but ambulatory), measurable disease, and normal organ/marrow function. Women must use effective contraception, as must men who agree to use condoms. Prior treatments for melanoma are allowed except for bevacizumab, aflibercept, or cemiplimab.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of combining Cemiplimab with Ziv-Aflibercept to see if they can shrink tumors or halt their growth in patients with metastatic uveal melanoma.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions that could affect various organs, infusion-related symptoms like fever or chills during drug administration, fatigue, digestive issues such as diarrhea or constipation, skin reactions at injection sites and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have been diagnosed with metastatic uveal melanoma.

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My organ and bone marrow functions are normal.

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My heart's pumping ability is within the normal range according to my recent echocardiogram.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

objective response rate (ORR)

Secondary outcome measures

Overall survival (OS)

Progression free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cemiplimab + Ziv-AfliberceptExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor

621 Previous Clinical Trials

380,573 Total Patients Enrolled

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,450 Total Patients Enrolled

Genzyme, a Sanofi CompanyIndustry Sponsor

524 Previous Clinical Trials

85,597 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many persons are taking part in this experiment?

"Correct. According to clinicaltrials.gov, this medical investigation is currently recruiting as of November 2nd 2023 after being posted on October 31st 2023; it requires 32 participants that will be observed at only one site."

Answered by AI

Is this research currently recruiting participants?

"This clinical trial as reported on the clinicaltrials.gov website is actively searching for members to join. It was first announced on October 31st, 2023 and was most recently updated two days later on November 2nd, 2023."

Answered by AI

What have been the findings regarding the security of a Cemiplimab + Ziv-Aflibercept treatment regimen?

"The safety of Cemiplimab + Ziv-Aflibercept has been assigned a score of 2 on our scale, as there is limited evidence available to demonstrate its efficacy. Nonetheless, the clinical data does support that it is safe to use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06121180.