Phase II Study of XL184 (cabozantinib) in combination with Nivolumab and Ipilimumab (CaboNivoIpi) in Patients with Radioiodine-refractory Differentiated Thyroid Cancer whose Cancer Progressed after One Prior VEGFR-Targeted Therapy
This phase II trial studies how well cabozantinib, nivolumab, and ipilimumab work in treating patients with differentiated thyroid cancer that does not respond to radioactive iodine and that worsened after treatment with a drug targeting the vascular endothelial growth factor receptor (VEGFR), a protein needed to form blood vessels. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab and ipilimumab may work better than the usual approach consisting of chemotherapy with drugs such as doxorubicin, sorafenib, and lenvatinib for this type of thyroid cancer.
Primary Objective: To assess the objective response rate, defined as the proportion of patients who have had a partial response (PR) or complete response (CR) within the first 6 months after initiation of therapy with XL184 (cabozantinib), nivolumab, and ipilimumab(CaboNivoIpi). Secondary Objectives: To assess duration of objective response (DOR), progression-free survival (PFS), and overall survival (OS). To assess tolerability and adverse events of CaboNivoIpi in patients with differentiated thyroid cancer (DTC). Exploratory Objectives: To correlate treatment response (Response Evaluation Criteria in Solid Tumors[RECIST] v1.1) with tumor mutation status. To correlate treatment response (RECIST v1.1) with frequency of tumor infiltrating lymphocytes in biopsies taken pre-treatment and after 12 weeks of CaboNivoIpi therapy. To evaluate the effect of CaboNivoIpi on T cell receptor (TCR) repertoire and to identify the frequency of shared T cell clones between tumor and peripheral blood. To evaluate the effect of XL184 (cabozantinib) alone and of the CaboNivoIpi combination on peripheral blood mononuclear cells (PBMCs) and to correlate their frequency with treatment response (RECIST v1.1). To evaluate the effect of XL184 (cabozantinib) alone and of the CaboNivoIpi combination on myeloid-derived suppressor cells (MDSCs) and to correlate their frequency with treatment response (RECIST v1.1). To correlate treatment response (RECIST v1.1) with programmed cell death protein 1 (PD-1) / programmed cell death-ligand 1 (PD-L1) expression in the primary/metastatic tumor.
Immunotherapy; Therapy (NOS)
BMS-936558 (Nivolumab); Cabozantinib (XL 184); Ipilimumab (); Nivolumab (Opdivo); Yervoy (Ipilimumab)
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