This prospective, single-center pilot study is being performed to find out whether Zr-89 crefmirlimab berdoxam "CD8 PET/CT" scans can improve the effectiveness of the tumor-infiltrating lymphocyte (TIL) therapy called lifileucel ("Study Treatment") in treating metastatic melanoma.
Participants must first provide consent to the companion protocol (UPCC 19426, PICSTAT CD8 PET) before being eligible to consent to this protocol.
Must have a confirmed diagnosis of unresectable or metastatic melanoma (Stage IV)
Participants must have progressed following ≥ 1 prior systemic therapy for Stage IV or unresectable Stage III disease including a PD- 1 blocking antibody; and if BRAF V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with MEK inhibitor.
At least two resectable previously non-irradiated lesions (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post- resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)
Lesions in the spleen should not be selected as resectable lesions, because they are not well evaluated by CD8 PET/CT imaging due to high background signal in that organ
Participants who have received an organ allograft or prior cell transfer therapy within the past 20 years that included a non-myeloablative or myeloablative chemotherapy regimen.
Participant has melanoma of uveal/ocular origin.
Participants who have a history of hypersensitivity to any component or excipient of lifileucel (AMTAGVI) or other study drugs: a. Hypersensitivity to PET tracer b. LD chemo regimen (cyclophosphamide, mesna, and fludarabine) c. Proleukin®, aldesleukin, IL-2 d. Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); (These participants may be eligible if current hypersensitivity has been excluded.) e. Any component of the lifileucel infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.
Participants with asymptomatic brain metastases who do not clinically require treatment may be considered for study participation.
Abramson Cancer Center at Penn Medicine
Lead sponsor
Iovance Biotherapeutics, Inc.
Collaborator