NCT05289193

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma
• Melanoma Stage III

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-11
• Primary completion: 2027-03-11
• Completion: 2027-03-11
• First posted: 2022-03-21
• Last updated: 2026-04-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study