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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure, Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Contact Information
Primary
Michael Postow, MD
postowm@mskcc.org
646-888-4589
Backup
Neeta Pandit-Taskar
pandit-n@MSKCC.ORG
2126393046
Time Frame
Start Date: 2022-03-11
Estimated Completion Date: 2026-03-11
Participants
Target number of participants: 28
Treatments
Experimental: Participants with Stage III Melanoma
All participants will have cytologically or histologically confirmed stage IIIB, IIIC, IIID melanoma that can be surgically removed.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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