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

April 1, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    • New York
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

    • 1cm 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

  • Bilirubin ≤1.5 X ULN

    • Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of study treatment (ipilimumab/nivolumab)
    • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of ipilimumab + nivolumab
    • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of study treatment (ipilimumab/nivolumab)

Note: Women who are not of childbearing potential (i.e., who are postmenopausal), or surgically sterile as well as azoospermic men do not require contraception

Exclusion Criteria:

  • 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.
  • Use of other investigational drugs before study drug administration 30 days and 5 half-times before study inclusion
  • Pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with Stage III Melanoma
All participants will have cytologically or histologically confirmed stage IIIB, IIIC, IIID melanoma that can be surgically removed.
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.

Other Names:
  • 89Zr-Df-Crefmirlimab
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major pathologic responses/MPR
Time Frame: up to 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Michael Postow, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Estimated)

March 11, 2027

Study Completion (Estimated)

March 11, 2027

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on PET Scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe