A Phase 2 Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Advanced Melanoma

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Full Title

A Phase 2 study of Fianlimab, Cemiplimab, and Ipilimumab in Anti-PD-1 Refractory Melanoma

Purpose

The purpose of this study is to see if the combination of fianlimab, cemiplimab, and ipilimumab works well against melanoma. The people in this study have melanoma that is inoperable (cannot be taken out with surgery) or metastatic (spread). In addition, their cancer keeps growing even after treatment that included immunotherapy.

Combining fianlimab, cemiplimab, and ipilimumab may work well against melanoma because each drug blocks different proteins that make tumors grow. Because they work in different ways, giving them together may be better than any of the three drugs given alone. This drug combination has been shown to shrink or halt the growth of melanoma in a small number of people. The drugs are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have inoperable or metastatic melanoma that keeps growing after treatment that included immunotherapy.
  • Not have had ipilimumab for advanced melanoma.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. James Smithy’s office at 646-888-6782.

Protocol

24-166

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT06594991