Last updated on April 2019

Study to Evaluate the Safety and Tolerability of Avelumab in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies


Brief description of study

Objectives

Primary Objectives:

For Arms D-G, to establish the safety, tolerability, and dose-limiting toxicities (DLTs) of different treatment combinations of avelumab when administered in combination with checkpoint agonist(s) with or without radiation, or radiation and cisplatin in patients with limited, locally advanced or metastatic solid tumors in order to estimate the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D).

To correlate pre- and post-treatment CD8 expression with clinical benefit (complete response [CR], partial response [PR], or stable disease [SD] for > 6 months).

Secondary Objectives:

To evaluate the efficacy of the different treatment combinations in patients with limited, locally advanced or metastatic solid tumors by assessing objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and immune-related RECIST (irRECIST).

To evaluate the efficacy of the different treatment combinations in patients with limited, locally advanced or metastatic solid tumors by assessing progression-free survival (PFS), duration of response (DOR), and overall survival (OS).

Clinical Study Identifier: NCT03217747

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Recruitment Status: Open


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