CD8+ T Cell Imaging During Immunotherapy Before Surgery in People with Melanoma

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Full Title

CD8+ Cell Imaging During Neoadjuvant ImmunoTherapy (The C-IT Neo Trial)

Purpose

The purpose of this study is to assess the effectiveness of giving nivolumab and ipilimumab immunotherapy before surgery in people with melanoma that will be surgically removed. It is hoped that these medications can reduce tumor size by destroying parts of the tumor before surgery and prevent disease from coming back after surgery. Both drugs work by boosting the power of the immune system to find and kill cancer cells. They are typically used to treat inoperable or metastatic melanoma; their use before surgery is considered investigational. Both are given intravenously (by vein).

During this study, researchers will also see whether PET/CT (positron emission tomography/computed tomography) scans using an experimental imaging agent called 89Zr-Df-crefmirlimab may be an effective way for identifying white blood cells called CD8+ T cells. These white blood cells are commonly found around and attached to cancer cells and play an active role in the immune response to cancer. Tracking the amount and location of CD8+ T cells may help doctors learn more about a patient’s cancer and the body’s response to immunotherapy.

Eligibility

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

  • Participants must have operable stage IIIB, IIIC, or IIID melanoma that will be surgically removed.
  • Prior treatment with immunotherapy is not permitted.
  • 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.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Michael Postow at 646-497-9067.

Protocol

21-456

Phase

II

Investigator

Co-Investigators

Diseases