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Checkpoint Inhibitor

Immunotherapy + Radiotherapy for Uveal Melanoma

Q: What safety protocols are in place for patients undergoing Immunotherapy?

<p>Despite a lack of evidence in its efficacy, <a href="https://www.withpower.com/clinical-trials/immunotherapy">Immunotherapy</a>'s safety profile has been substantiated by Phase 2 data. Consequently, our team at Power assigned it a rating of 2 on the scale from 1 to 3.</p>

Phase 2

Recruiting

Research Sponsored by California Pacific Medical Center Research Institute

Eligibility Criteria Checklist

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

Must have

No active Hepatitis B

Performance status 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a new immunotherapy treatment for cancer that includes two drugs and radiation therapy.

Who is the study for?

This trial is for individuals with metastatic uveal melanoma who have measurable cancer spread, normal liver and kidney function tests, no active hepatitis B or HIV infection, and are generally in good health (performance status 0-1). Pregnant people, those with large liver tumor volumes (>50%), active brain metastases, prior Opdualag/relatlimab treatment, certain autoimmune diseases or previous specific liver treatments are excluded.Check my eligibility

What is being tested?

The study is testing the combination of stereotactic body radiotherapy (SBRT) given as three doses to target up to five cancer spots along with an immunotherapy drug called Opdualag (nivolumab and relatlimab) every four weeks for two years. The goal is to see how well they work together against metastatic uveal melanoma.See study design

What are the potential side effects?

Possible side effects include typical reactions from radiation like skin irritation and fatigue. Immunotherapy may cause immune-related issues such as inflammation in various organs including the intestines and lungs, potential hormone gland problems, skin rashes or itching.

Eligibility Criteria

Inclusion Criteria

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

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I do not have active Hepatitis B.

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I can carry out all my usual activities without help.

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I do not have HIV.

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My eye melanoma has spread and can be measured.

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I am not receiving any other treatments.

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

safety and tolerability of the therapy

Secondary outcome measures

Response rate

Other outcome measures

Overall survival

Progression-free survival

Side effects data

From 2008 Phase 4 trial • 275 Patients • NCT00267202

20%

Injection site reaction

14%

Upper respiratory tract infection

14%

Injection site erythema

14%

Injection site pruritus

12%

Nasopharyngitis

10%

Injection site swelling

Injection site induration

Injection site urticaria

Headache

Pruritus

Sinusitis

Cough

Viral upper respiratory tract infection

Abortion induced

Asthma

Rectal cancer

Cellulitis staphylococcal

Sexual abuse

100%

80%

60%

40%

20%

Study treatment Arm

Omalizumab

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: one armExperimental Treatment2 Interventions

see below

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Immunotherapy

2016

Completed Phase 4

~1270

stereotactic body radiotherapy

2016

Completed Phase 4

~140

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

California Pacific Medical Center Research InstituteLead Sponsor

43 Previous Clinical Trials

12,486 Total Patients Enrolled

David R Minor, MDStudy ChairCalifornia Pacific Med Center Research Inst.

2 Previous Clinical Trials

36 Total Patients Enrolled

Media Library

Opdualag (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05077280 — Phase 2

Uveal Melanoma Research Study Groups: one arm

Uveal Melanoma Clinical Trial 2023: Opdualag Highlights & Side Effects. Trial Name: NCT05077280 — Phase 2

Opdualag (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05077280 — Phase 2

Frequently Asked Questions

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

What is the scope of enrollment for this investigation?

"Affirmative. According to the data provided on clinicaltrials.gov, this medical trial is in search of eligible candidates with its commencement date being September 20th 2021 and last updated October 19th 2021. 40 participants are sought at a single site for the study."

Answered by AI

Is this investigation currently accepting new participants?

"Clinicaltrials.gov confirms that this medical research is presently in search of participants, with the initial posting taking place on September 20th 2021 and a subsequent update made October 19th 2021."

Answered by AI

What safety protocols are in place for patients undergoing Immunotherapy?

"Despite a lack of evidence in its efficacy, Immunotherapy's safety profile has been substantiated by Phase 2 data. Consequently, our team at Power assigned it a rating of 2 on the scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma

2021. "A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05077280.