Project Duration: 2016-2025
MOHCCN Consortium: Princess Margaret Cancer Consortium
Investigators: Drs. Lillian Siu, Pamela Ohashi, Marcus Butler, Philippe Bedard, David Cescon, Eleftherios Diamandis, Scott Bratman, David Brooks, Aaron Hansen, Tracy McGaha, Linh Nguyen, Amit Oza, Trevor Pugh, Albiruni Razak, Anna Spreafico, Ming Tsao
INSPIRE (NCT02644369) is a flagship, investigator-initiated phase II study conducted by the Tumor Immunotherapy Program (TIP) at the Princess Margaret, which enrolled 106 patients with advanced solid tumors from March 21, 2016 to May 9, 2018. INSPIRE had 5 patient cohorts: (A) squamous cell carcinoma of the head and neck (n=19), (B) triple negative breast cancer (n=22), (C) high grade serous ovarian cancer (n=21), (D) malignant melanoma (n=12), (E) mixed solid tumors (n=32), all treated with single agent pembrolizumab given intravenously every 3 weeks. INSPIRE is considered a ‘gold standard’ for investigator-initiated therapeutic studies at the Princess Margaret. It comprises data-rich cohorts that collected pre-treatment and on-treatment tumor and blood samples to enable the investigations to evaluate multi-omic predictive and pharmacodynamic biomarkers of sensitivity or resistance to immune checkpoint blockade. Multiple publications have emerged from data generated from the INSPIRE study and additional research are ongoing (Clouthier et al, JITC 2018 PMID 30867072; Bratman, Yang et al. Nat Cancer 2020; Yang et al. Nat Comm 2021 PMID 34446728).