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Subcutaneous vs Intravenous Nivolumab + Relatlimab for Melanoma

Phase 2

Recruiting

Research Sponsored by Bristol-Myers Squibb

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 up to approximately 2.5 years

Awards & highlights

Study Summary

This trial will assess how patients prefer nivolumab SC or a combination of nivolumab and relatlimab SC, and gather safety data on switching from IV to SC.

Who is the study for?

This trial is for adults with melanoma, either metastatic without prior treatment or resected and confirmed disease-free within the last 12 weeks. Participants should have low disability and be at intermediate to advanced risk. Those with brain cancer treated by radiation, eye/mucous membrane cancers, autoimmune diseases, or on steroids/immunosuppressants cannot join.Check my eligibility

What is being tested?

The study evaluates patient preference between subcutaneous (under the skin) injections versus intravenous (into a vein) administration of Nivolumab alone or combined with Relatlimab. It also examines safety related to switching from IV to SC delivery.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs like the lungs or intestines, infusion-related symptoms such as fever or chills, fatigue, skin issues like rash, and potential increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.5 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

Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ)

Secondary outcome measures

Number of deaths

Number of participants with AEs leading to discontinuation

Number of participants with Adverse Events (AEs)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Resected MelanomaExperimental Treatment2 Interventions

Group II: Cohort 1: Metastatic MelanomaExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

nivolumab

2016

Completed Phase 3

~4960

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,964 Total Patients Enrolled

177 Trials studying Melanoma

57,386 Patients Enrolled for Melanoma

Frequently Asked Questions

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

How many sites across the US are conducting this clinical trial?

"Presently, this trial is being administrated in 29 healthcare centres across the United States. These medical establishments are located in Phoenix, San Francisco and Albuquerque as well as many other cities. To reduce your travelling needs during enrollment, you should choose a clinic nearby to participate."

Answered by AI

Are there any remaining openings for participants in this research endeavor?

"The clinical trial information available via clinicaltrials.gov indicates that this particular medication is not currently engaging in patient recruitment. It was first listed on December 29th 2023, and the latest update occurred October 20th of the same year. Despite this, there are 734 distinct trials actively seeking patients at present."

Answered by AI

Is Cohort 1: Metastatic Melanoma a hazardous condition for individuals?

"The safety of Cohort 1: Metastatic Melanoma was deemed a 2 according to the assessment conducted by our team at Power. This is because Phase 2 trials have demonstrated some evidence that this medication does not pose major risks, but there are no results yet indicating its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

2023. "A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06101134.

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