Study of Combo of Anti-LAG-3 & Anti-PD-1 Antibodies in Subjects with Advanced or Metastatic Melanoma

Study of Combo of Anti-LAG-3 & Anti-PD-1 Antibodies in Subjects with Advanced or Metastatic Melanoma

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Purpose of this Study

We are doing this study to find the most effective, safe dose of a combination of the drugs fianlimab and ceminplimab. We want to know if this combination is an option for people with melanoma. We will compare how well this drug combination works to the usual treatment of relatlimab and nivolumab, which has the brand name Opdualag®.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with stage III and stage IV (metastatic) melanoma
  • Have disease that is unresectable (cannot be removed by surgery)
  • Have not received any prior systemic therapy for unresectable or metastatic melanoma
For more information about who can join this study, please contact the study team at WakeCountyOncResearch@dm.duke.edu or 919-954-3085.

Age Range

18-85

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (like a coin flip) to either:
  • Get a dose of fianlimab + cemiplimab every 3 weeks; OR
  • Get a dose of Opdualag every 4 weeks
Both the study drug combination and Opdualag are given into a vein using a needle. This is called an intravenous (IV) infusion. You will take your assigned study regimen for as long as the study doctor believes you are getting a benefit. The following tests and procedures will be performed throughout the study:
  • Physical exams
  • Blood draws and urine samples
  • Tumor biopsy
  • Imaging (MRI/CT)
We will schedule you to come in for some return visits after you stop taking your study regimen. We will keep in touch with you to see how you are doing for up to 6 years after the final participant finishes the study.

Locations

Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

Study Details

Full Title

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab
Versus Relatlimab and Nivolumab in Participants with Unresectable or
Metastatic Melanoma.

Principal Investigator

Riddhishkumar
Shah

Protocol Number

PRO00116364

NCT ID

NCT06246916

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov