A Phase II Study of CMP-001 and Nivolumab in People with Advanced Melanoma that Persists Despite Immunotherapy

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Full Title

A Multicenter, Open Label, Phase 2 Study of Intratumoral CMP-001 in Combination with Intravenous Nivolumab in Subjects with Refractory Unresectable or Metastatic Melanoma

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the investigational drug CMP-001 with the immunotherapy drug nivolumab in people with inoperable or metastatic melanoma that continues to grow despite standard immunotherapy. It is hoped that CMP-001 may stimulate fighter cells (T cells) in the immune system to attack the cancer.

Combining CMP-001 with nivolumab may make nivolumab more effective in boosting the ability of the immune system to shrink or halt the growth of tumors. CMP-001 is injected directly into a tumor and nivolumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have advanced melanoma that cannot be surgically removed or has spread.
  • Patients’ tumors must continue to grow even though they already received a PD-1 immunotherapy drug, such as nivolumab or pembrolizumab.
  • There must be at least one tumor near the surface of the skin that is accessible to receive the injection of CMP-001.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Alexander Shoushtari at 646-888-4161.

Protocol

21-286

Phase

II

Diseases