CD8+ T Cell Imaging During Pre-Surgery Immunotherapy for Melanoma Patients

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05289193

This study is testing if a combination of immunotherapy drugs, nivolumab and ipilimumab, given before surgery can help shrink melanoma tumors and prevent them from returning. It also explores a new PET scan to see how the immune system responds to treatment.

Patient Parameters

Program Overview

This clinical trial is investigating whether using the immunotherapy drugs nivolumab and ipilimumab before surgery can effectively shrink melanoma tumors and stop them from coming back after surgery. This approach is known as neoadjuvant therapy. The study also includes a new type of PET scan that images the immune system to see if it can predict how well the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and agree to the study requirements, and sign a consent form.
  • Adults aged 18 and older.
  • Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Diagnosed with stage IIIB, IIIC, IIID, or IV melanoma that can be surgically removed.
  • At least 1 cm of the tumor must be visible on standard imaging tests like PET or CT scans.
  • Meet specific blood test criteria for white blood cells, neutrophils, platelets, hemoglobin, creatinine, AST, ALT, and bilirubin levels.
  • Women who can become pregnant must use effective birth control during the study and for 23 weeks after the last treatment dose.
  • Women must have a negative pregnancy test before starting treatment.
  • Men who are sexually active with women who can become pregnant must use effective birth control during the study and for 31 weeks after the last treatment dose.

Exclusion Criteria

  • Have any active autoimmune disease or need for immunosuppressive treatment.
  • Have an active hepatitis B infection.
  • Have previously received immunotherapy targeting CTLA-4 or PD-1/PD-L1.
  • Have melanoma that cannot be surgically removed.
  • Have tested positive for HIV or have AIDS.
  • Have had a severe allergic reaction to any monoclonal antibody.
  • Have medical conditions that could make treatment unsafe or affect the study results.
  • Have had their spleen removed or have spleen disorders.
  • Have used other investigational drugs recently.
  • Are pregnant or breastfeeding.

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