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Checkpoint Inhibitor

Nivolumab + Relatlimab for Uveal Melanoma

Phase 2
Waitlist Available
Research Sponsored by Jose Lutzky, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be ≥ 18 years of age on day of signing informed consent
Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial will test if nivolumab and relatlimab can shrink tumors in people with metastatic uveal melanoma.

Who is the study for?
This trial is for adults with metastatic uveal melanoma who haven't been treated with certain immune-blocking drugs. They must not be pregnant, agree to contraception, and have tumors that can be measured and biopsied. Participants need proper organ function, no active infections or severe psychiatric disorders, and cannot have had recent treatments that could affect the trial.Check my eligibility
What is being tested?
The study tests if combining nivolumab with relatlimab reduces tumor size in patients with advanced eye melanoma. It's for those who haven't used similar drugs before. The treatment's effectiveness will be monitored by measuring changes in tumor size.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation of organs, infusion reactions like fever or chills during drug administration, fatigue, possible infection risk increase due to immune system suppression, and allergic responses to the medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I have untreated metastatic uveal melanoma and haven't received specific immune therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Survival (OS)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab Plus Relatlimab GroupExperimental Treatment2 Interventions
Participants in this group will receive Nivolumab and Relatlimab administered together on Day 1 of every 4 week cycle. Both drugs will be administered until disease progression or intolerable toxicity for up to 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Relatlimab
2018
Completed Phase 2
~1110

Find a Location

Who is running the clinical trial?

Jose Lutzky, MDLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,487 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,167 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04552223 — 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 present status of Nivolumab in terms of federal drug regulations?

"Nivolumab's score of 2 on our 1-3 scale reflects that, while there is some evidence backing its safety, this medication has not yet been proven effective."

Answered by AI

What conditions does Nivolumab commonly help alleviate?

"Nivolumab is an immunotherapy treatment that can be used to fight cancerous neoplasms as well as other serious conditions like metastatic esophageal adenocarcinoma and unresectable melanoma."

Answered by AI

Does this clinical trial break new ground in the medical field?

"Nivolumab has been researched since 2010 when the first study, sponsored by Medarex, was completed with 127 participants. After further Phase 1 trials, Nivolumab received drug approval in . There are now 749 active studies involving this medication across 2348 cities and 50 countries."

Answered by AI

How many people can be enrolled in this research project?

"That is correct, the latest information available on clinicaltrials.gov suggests that this trial is still looking for patients to enroll. The posting went up on November 10th 2020 with the most recent update happening August 23rd 2022. They are currently searching for 27 people to participate at 1 location."

Answered by AI

Are participants still being recruited for this research project?

"The trial is currently underway, as per the latest update on clinicaltrials.gov which was on 8/23/2022. This research was first posted on 11/10/2020 and is looking for 27 individuals at 1 location."

Answered by AI

What other scientific research has been conducted on Nivolumab?

"At the moment, there are 749 ongoing clinical trials evaluating Nivolumab's efficacy. Out of these, 82 have reached Phase 3. Many of the studies taking place in Basel, BE however 40407 locations worldwide are running similar investigations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma
Jose Lutzky, MD 2020. "Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04552223.
~4 spots leftby Dec 2024
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