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Major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR rate of pembrolizumab as a single agent. Additionally the dynamics of the tumor microenvironment changes on treatment by comparing pre-, on- and post-treatment samples will be evaluated.
The primary objective is to assess the MPR rate (<10% of residual viable tumor cells) at the time of surgery in evaluable subjects treated with canakinumab alone and in combination with pembrolizumab based on central review.
Experimental: canakinumab monotherapy All patients will receive canakinumab (ACZ885) prior to surgery Experimental: canakinumab + pembrolizumab All patients will receive canakinumab (ACZ885) and pembrolizumab prior to surgery Experimental: pembrolizumab monotherapy All patients will receive 2 doses of pembrolizumab prior to surgery
Other
II
Adult
Vu, John
Lung
National
Baptist MD Anderson Cancer Center
Key inclusion criteria: Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors. Subject must be eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment). A mandatory newly obtained tissue biopsy from primary site is required for study enrollment. An archival biopsy is also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment. Note: Aspirates will not be accepted. - Eastern Cooperative oncology group (ECOG) performance status of 0 or 1. Key exclusion criteria: Subjects with unresectable or metastatic disease. History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization. Control of the disorder with replacement therapy is permitted Subject with suspected or proven immunocompromised state or infections Other protocol-defined inclusion/exclusion criteria may apply.
NCT03968419
CACZ885V2201C/CANOPY-N
Treatment
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