Last updated on August 2019

Addition of SNS-301 to Ongoing Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN


Brief description of study

To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 added to ongoing checkpoint inhibitor therapy in ASPH+ locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) patients.

Detailed Study Description

This is a Phase 1/2, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of SNS-301 delivered intradermally in addition to pembrolizumab in patients with ASPH+ locally advanced unresectable or metastatic/recurrent SCCHN. The trial population consists of patients with ASPH+ locally advanced unresectable or metastatic/recurrent SCCHN who are currently receiving pembrolizumab or nivolumab therapy. Patients must have a best response of stable disease (SD) or first evidence of unconfirmed progressive disease (PD) after a minimum of 12 weeks of pembrolizumab or nivolumab therapy. Prior chemotherapy is allowed but not required. Patients receiving nivolumab will be switched over to pembrolizumab at the time of entering this study.

Clinical Study Identifier: NCT04034225

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Georgetown University

Washington, WA United States
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