IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in Advanced Melanoma

What is the Purpose of this Study?

This study focuses on adults with advanced melanoma (a type of skin cancer) that has spread or cannot be surgically removed. The purpose of the study is to determine whether an experimental drug called IMC-F106C, in combination with a standard therapy (nivolumab), works better than the standard therapy (nivolumab alone or in combination with relatlimab) at stopping tumors from growing. Researchers also want to better understand the safety of IMC-F106C in combination with nivolumab and learn whether a lower or higher dose of IMC-F106C in combination with this standard therapy works better and/or is safer. In addition, the study will evaluate how well participants feel after receiving the study drug or standard therapy. IMC-F106C may help T cells (part of the body’s immune system) stick to and attack cancer cells. Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for various conditions, but the combination of IMC-F106C and nivolumab in this study is investigational.


Eligibility

  • * Participants must be HLA-A\*02:01-positive
  • * Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
  • * Archived or fresh tumor tissue sample that must be confirmed as adequate
  • * Participants must have measurable disease per RECIST 1.1
Show more

Where can I participate?

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

What is the full name of this clinical trial?

IMC-F106C-301: A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma

Study Details
Disease Type/Condition

Melanoma

Principal Investigator

Hamid, Omid

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Inderjit Mehmi, Justin Moyers, Kristopher Wentzel, Mark Faries, Navid Hafez, Vi K. Chiu

Age Group

Adult

Phase

III

IRB Number

STUDY00003066

ClinicalTrials.gov ID

NCT06112314

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Melanoma

Principal Investigator

Hamid, Omid

Age Group

Adult

Phase

III

IRB Number

IMC-F106C-301

ClinicalTrials.gov ID

NCT06112314

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org