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Ziv-Aflibercept for Uveal Melanoma

Phase 2

Waitlist Available

Led By Wenyin Shi, MD, PhD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

Study Summary

This trial is studying how well two different treatments work in treating patients with uveal melanoma.

Eligible Conditions

Uveal Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 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

Incidence of grade 3 or higher toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary outcome measures

Radiation maculopathy rate defined as ophthalmoscopic detection of macular edema perivascular sheathing

Radiation papillopathy rate defined as ophthalmoscopic detection of peripapillary encircling nerve fiber layer infarction

Side effects data

From 2018 Phase 2 trial • 22 Patients • NCT02101918

77%

Hypertension

68%

Headache

45%

Mucositis oral

41%

Hoarseness

32%

Proteinuria

27%

Fatigue

23%

Constipation

23%

Nausea

23%

Abdominal pain

23%

Vomiting

18%

Alanine aminotransferase increased

18%

Diarrhea

18%

Arthralgia

14%

Neutrophil count decreased

14%

Creatinine increased

14%

Anorexia

14%

Pain

14%

Palmar-plantar erythrodysesthesia syndrome

14%

Epistaxis

14%

Weight loss

14%

Aspartate aminotransferase increased

14%

Platelet count decreased

14%

Anemia

Sinusitis

Dehydration

Upper gastrointestinal hemorrhage

cholecystitis

Hemorrhage Upper GI

Pain Abdominal

100%

80%

60%

40%

20%

Study treatment Arm

Aflibercept 6 mg /kg IV

Trial Design

2Treatment groups

Experimental Treatment

Group I: B. Stereotactic body radiation therapy, ziv-afliberceptExperimental Treatment1 Intervention

Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group II: A. Stereotactic body radiation therapy, ziv-afliberceptExperimental Treatment1 Intervention

Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Aflibercept

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,908 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

617 Previous Clinical Trials

380,202 Total Patients Enrolled

Wenyin Shi, MD, PhDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

6 Previous Clinical Trials

78 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 is Ziv-Aflibercept most often used?

"Ziv-Aflibercept is often used to help patients with wet age-related macular degeneration, however it can also be effective for those struggling with macular edema, diabetic macular edema, and regular macular degeneration."

Answered by AI

Are we currently enrolling patients for this trial?

"Yes, the trial is recruiting participants as indicated by the listing on clinicaltrials.gov. The study was originally posted 8/9/2019 and has been updated as recently as 9/7/2022. They are searching for 36 patients from 1 location."

Answered by AI

What is the margin of safety for Ziv-Aflibercept?

"Ziv-Aflibercept is currently in Phase 2 of clinical trials, meaning that while there is evidence supporting its safety, none yet exists to show that the medication is effective."

Answered by AI

How many patients are enrolled in this clinical trial?

"Yes, an updated review of clinicaltrials.gov reveals that this study is still recruiting patients. The trial was first posted on 8/9/2019 and was most recently edited on 9/7/2022; at the moment, they are looking for 36 more participants to be studied at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma

2019. "Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03712904.