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ACTIVE NOT RECRUITING
NCT05289193
PHASE2

CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2022-03-11

Completion Date

2027-03-11

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

PET Scan

Patients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma.

DRUG

Nivolumab

Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg.

DRUG

Ipilimumab

Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg.

PROCEDURE

Surgical Resection of Melanoma

Patients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma.

Locations (4)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States