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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Mar 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a combination of two immunotherapy drugs, nivolumab and ipilimumab, can help shrink melanoma tumors before surgery. By using this treatment, researchers hope to not only reduce the size of the cancer but also prevent it from coming back after the surgery. Additionally, the study will investigate a new type of PET scan that can visualize the immune system's response to the treatment, which might help predict how well the therapy is working.

To participate in this trial, you need to be an adult at least 18 years old with advanced melanoma that can be surgically removed. You should also be in good overall health, meaning you can perform daily activities with little assistance. The trial is currently looking for participants, and those who join can expect to receive the immunotherapy treatment before their surgery, along with monitoring to assess how their body is responding to the drugs. It's important to note that there are specific health criteria that must be met to qualify for the study, so potential participants should discuss their situation with their doctor.

Gender

ALL

Eligibility criteria

• 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