CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma
CD8+ Cell Imaging During Neoadjuvant ImmunoTherapy (The C-IT Neo Trial)
1 other identifier
interventional
28
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2022
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2022
CompletedStudy Start
First participant enrolled
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2026
CompletedOctober 23, 2025
October 1, 2025
4 years
March 11, 2022
October 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major pathologic responses/MPR
Participants' disease will be assessed for MPR as per previously established criteria for neoadjuvant trials (near complete response ≤10% viable; complete response 0% viable). Pathologic response (≤50% viable) will also be estimated.
up to 2 years
Study Arms (1)
Participants with Stage III Melanoma
EXPERIMENTALAll participants will have cytologically or histologically confirmed stage IIIB, IIIC, IIID melanoma that can be surgically removed.
Interventions
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.
Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg.
Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg.
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.
Eligibility Criteria
You may qualify if:
- Patient is capable of understanding and complying with the protocol requirements and has signed the Informed Consent document.
- Adults at least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Cytologically or histologically confirmed stage IIIB, IIIC, IIID, or IV melanoma that can be surgically removed.
- Notes:
- In-transit melanoma is acceptable.
- Patients can enroll regardless of their BRAF mutational status
- cm of tumor needs to be visible on standard imaging (i.e. FDG PET or CT scan)
- Screening laboratory values must meet the following criteria:
- WBC ≥ 2.0x109/L
- Neutrophils ≥ 1.5x109/L
- Platelets ≥ 100 x109/L
- Hemoglobin ≥ 5.5 mmol/L
- Creatinine ≤ 1.5x ULN
- AST ≤ 1.5 x ULN and ALT ≤ 1.5 x ULN
- +5 more criteria
You may not qualify if:
- Subjects with any active autoimmune disease (current symptoms or requirement for immunosuppression at the time of study start).
- Positive active hepatitis B viral infection (+viral load by PCR)
- Prior immunotherapy targeting CTLA-4 and/or PD-1/PD-L1 for any disease.
- Potentially unresectable melanoma.
- History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- History of severe hypersensitivity reaction to any monoclonal antibody
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of treatment hazardous or obscure the interpretation of toxicity
- Patients who have undergone splenectomy or have other splenic disorders. The normal spleen usually has CD8+ cell activity and serves as a positive control to enable proper imaging technique.
- Pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Postow, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2022
First Posted
March 21, 2022
Study Start
March 11, 2022
Primary Completion
March 11, 2026
Study Completion
March 11, 2026
Last Updated
October 23, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.