Progressive Disease Clinical Trial
Official title:
A Phase 2 Clinical Trial of Axitinib and Avelumab in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma (ACC)
This phase II trial studies how well axitinib and avelumab work in treating patients with adenoid cystic carcinoma that has come back or spread to other places in the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and avelumab together may help to control adenoid cystic carcinoma.
PRIMARY OBJECTIVES: I. Assess the objective response rate (ORR) to axitinib and avelumab combination according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria patients with recurrent or metastatic adenoid cystic carcinoma (ACC) who have evidence of disease progression within 6 months prior to study enrollment. SECONDARY OBJECTIVES: I. Assess ORR to axitinib and avelumab combination according to immune-related (ir)RECIST criteria patients with recurrent or metastatic adenoid cystic carcinoma (ACC). II. Evaluate median progression free survival (PFS), PFS rate at 6 months after start of treatment. III. Evaluate median overall survival (OS), OS rate at 6 months after start of treatment. IV. Evaluate duration of response (DoR). V. Evaluate safety and toxicity. EXPLORATORY OBJECTIVES: I. Assess molecular markers associated with response and resistance to the study combination using tissue and/or plasma obtained from study participants. OUTLINE: Patients receive axitinib orally (PO) twice daily (BID) on days 1-28 and avelumab intravenously (IV) over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 and 90 days and then every 6 months thereafter. ;
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