Exelixis Announces Amendment to Clinical Research Protocol for Phase 1B Trial of Cabozantinib in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
January 04, 2018 at 08:00 am
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Exelixis, Inc. announced an amendment to the protocol for the phase 1b trial of cabozantinib in combination with atezolizumab (TECENTRIQ®) in patients with locally advanced or metastatic solid tumors. The amendment adds four new expansion cohorts to the trial, which will now include patients with NSCLC and CRPC, in addition to previously included patients with renal cell carcinoma (RCC) and urothelial carcinoma (UC). The primary objective in the expansion stage of this trial remains to determine the objective response rate in each cohort. New expansion cohorts includes patients with advanced non-squamous NSCLC without a defined tumor genetic alteration (EGFR, ALK, ROS1, or BRAF) who have not received prior therapy with an immune checkpoint inhibitor. patients with NSCLC without a defined tumor genetic alteration who have progressed following treatment with an immune checkpoint inhibitor. patients with UC who have progressed following treatment with an immune checkpoint inhibitor. patients with CRPC who have previously received enzalutamide and/or abiraterone acetate and experienced radiographic disease progression in soft tissue. The original trial protocol included four expansion cohorts, which will remain in the amended study patients with RCC with clear cell histology who have not had prior systemic anticancer therapy. patients with UC who have progressed on or after platinum-containing chemotherapy. patients with UC who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced or metastatic disease. patients with UC who are eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced or metastatic disease. This multicenter, phase 1b, open-label study is divided into two parts: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase is enrolling up to 36 patients either with advanced RCC with or without prior systemic therapy or with inoperable, locally advanced, metastatic or recurrent UC (including renal, pelvis, ureter, urinary bladder and urethra) after prior platinum-based therapy. The primary objective is to determine the optimal dose and schedule of daily oral administration of cabozantinib when given in combination with atezolizumab to inform the trial’s subsequent expansion stage. Cabozantinib doses of 40 mg daily and 60 mg daily are being evaluated. All patients will receive the standard atezolizumab dosing regimen (1200 mg infusion once every 3 weeks).
Exelixis, Inc. is an oncology company. The Company is engaged in developing medicines and combination regimens at the forefront of cancer care. It has produced four marketed pharmaceutical products, two of which are formulations of its flagship molecule, cabozantinib. Cabozantinib is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors and RET and has been also approved as CABOMETYX tablets for advanced renal cell carcinoma (RCC), for previously treated hepatocellular carcinoma (HCC) and for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), and as COMETRIQ capsules for progressive, metastatic medullary thyroid cancer (MTC). The Company's other two products are COTELLIC, an inhibitor of MEK approved as part of multiple combination regimens to treat specific forms of advanced melanoma and MINNEBRO an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR) approved the treatment of hypertension.
Exelixis Announces Amendment to Clinical Research Protocol for Phase 1B Trial of Cabozantinib in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors