ACTIVE_NOT_RECRUITING

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

Conditions

Melanoma Melanoma Stage III CD8+ Cell Imaging C-IT Neo Trial stage III melanoma 89Zr-Df-Crefmirlimab Memorial Sloan Kettering Cancer Center 21-456

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2022-03-11

Study Completion:2026-03-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05289193

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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)	* 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

Inclusion Criteria

Exclusion 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.
* 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)

* 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

Contacts and Locations

Principal Investigator

Michael Postow, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Michael Postow, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Registration Dates

Study Start Date2022-03-11

Study Completion Date2026-03-11

Study Record Updates

Study Start Date2022-03-11

Study Completion Date2026-03-11

Terms related to this study

Keywords Provided by Researchers

CD8+ Cell Imaging
C-IT Neo Trial
stage III melanoma
89Zr-Df-Crefmirlimab
Memorial Sloan Kettering Cancer Center
21-456

Additional Relevant MeSH Terms

Melanoma
Melanoma Stage III