Lifileucel (TIL) Therapy After PD-1 Blockade Failure in Kidney Cancer

Ki vehet részt

• Histologically or cytologically confirmed, advanced or metastatic renal cell carcinoma with clear cell, papillary, sarcomatoid (with or without other subtypes present), or unclassified histology. Other non-clear cell subtypes are also eligible if the patient has had a prior documented response to immune checkpoint inhibitor therapy; Participants must have measurable disease with at least two malignant lesions, one for disease monitoring as response to therapy and one for TIL harvest; Age ≥18 years; Received one of the following regimens:; Anti-PD-(L)1 immune checkpoint inhibitor (ICI) with or without an anti-CTLA-4 ICI or VEGF tyrosine kinase inhibitor (TKI) for treatment of advanced/metastatic disease, and experienced either (1) radiographic progression of disease while on treatment or (2) best response of stable disease after at least 6 months; Adjuvant anti-PD-(L)1 ICI after nephrectomy for localized disease and had either (1) disease recurrence while receiving adjuvant ICI or (2) disease recurrence within 6 months of the final dose of any amount of adjuvant ICI; Prior HIF2α inhibitor exposure in the adjuvant or advanced/metastatic setting is allowed but not required; Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months in the opinion of the Investigator; Participants must have adequate organ and marrow function as defined in the protocol; Patients with definitively treated brain metastases may be considered for enrollment if the patient is clinically stable for ≥ 14 days, with no lesions on follow-up imaging and no requirement for ongoing steroid treatment; Participants must have a washout period from any anticancer therapy prior to tumor harvest. The protocol contains provisions for optional use of "bridging" TKI between tumor harvest and lymphodepleting chemotherapy; Palliative radiation therapy is permitted as long as it does not involve lesions being selected for resection for TIL manufacturing, or being assessed radiographically as target lesions; Participants must have recovered from all prior anti-cancer therapy-related adverse events (AEs), as defined in the protocol; Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control; Previous surgical procedure(s) is/are permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection

Ki nem vehet részt

• Patients 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
• Patients who have a history of hypersensitivity to any component of the study intervention
• Patients with rapidly progressive disease or symptomatic disease requiring urgent treatment per investigator discretion
• Patients who are on chronic systemic steroid therapy except for those requiring steroid therapy for management of adrenal insufficiency
• Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease [SCID] and acquired immunodeficiency syndrome [AIDS])
• Patients with any other primary malignancy that is radiographically visible or is expected to require treatment within the next three years
• Patients with symptomatic and/or untreated brain metastases
• Patients who are pregnant or breastfeeding
• Patients who are hypoxemic (oxygen saturation <90%) on room air at baseline or who require supplemental oxygen; Other protocol-defined inclusion/exclusion criteria may apply