← Back to Search

Relatlimab for Skin Cancer

Phase 2
Waitlist Available
Led By Rodabe N Amaria
Research Sponsored by M.D. Anderson Cancer Center
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 2 years
Awards & highlights

Study Summary

This trial is testing nivolumab with or without ipilimumab or relatlimab before surgery to see if it can help treat patients with stage IIIB-IV melanoma.

Eligible Conditions
  • Skin Cancer
  • Cutaneous Melanoma
  • Uveal Melanoma
  • Melanoma
  • Eye Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Arm C: Number of Participants With the Pathologic Response Rate
Secondary outcome measures
Arm C: Number of Participants Assessed by Safety and Feasibility of Relatlimab With Nivolumab Delivered in the Neoadjuvant Setting
Arm C: Number of Participants With Immunologic and Molecular Mechanisms of Response and Resistance.
Arm C: Number of Participants With Objective Response Rate (ORR) of Relatlimab With Nivolumab Administered in the Neoadjuvant Setting.
+1 more
Other outcome measures
Molecular markers with potential predictive value for the treatment of melanoma

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (nivolumab, relatlimab, surgery)Experimental Treatment4 Interventions
Patients receive nivolumab IV over 1 hour and relatlimab IV over 1 hour on days 1 and 29. Patients then undergo surgery on day 57. After surgery, patients receive nivolumab IV over 1 hour and relatlimab IV over 1 hour every 4 weeks for 10 doses in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (nivolumab, ipilimumab, surgery)Experimental Treatment4 Interventions
Patients receive nivolumab IV over 1 hour and ipilimumab IV over 90 minutes on days 1, 22, and 43. Patients then undergo surgery on day 57. After surgery, patients receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Group III: Arm A (nivolumab, surgery)Experimental Treatment3 Interventions
Patients receive nivolumab IV over 30 minutes on days 1, 15, 29, and 43. Patients then undergo surgery on day 57. After surgery, patients receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved
Relatlimab
FDA approved
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,436 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,163 Total Patients Enrolled
Rodabe N AmariaPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
105 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Neoadjuvant and Adjuvant Checkpoint Blockade
2016. "Neoadjuvant and Adjuvant Checkpoint Blockade". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02519322.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top