Spots Global Cancer Trial Database for Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN
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Trial Identification
Brief Title: Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN
Official Title: An Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic/Recurrent Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT04034225
Study Description
Brief Summary: To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 added to checkpoint inhibitor therapy in locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) patients.
Detailed 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 locally advanced unresectable or metastatic/recurrent SCCHN. The trial population consists of patients with locally advanced unresectable or metastatic/recurrent SCCHN who are currently receiving checkpoint inhibitor (CPI) therapy (Cohort A) or are naïve to CPI therapy (Cohort B). Patients who are currently receiving CPI therapy must have a best response of stable disease (SD) or first evidence of progressive disease (PD) after a minimum of 12 weeks of treatment with a CPI. Patients receiving a CPI other than pembrolizumab will be switched over to pembrolizumab at the time of entering this study. Patients receiving pembrolizumab in the first line setting must be PD-L1 positive.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California - San Francisco, San Francisco, California, United States
Christiana Care, Newark, Delaware, United States
Georgetown University, Washington, District of Columbia, United States
Emory University, Atlanta, Georgia, United States
Rush University, Chicago, Illinois, United States
Alliance for Multispeciality Research, Kansas City, Missouri, United States
Mt. Sinai, New York, New York, United States
New Orleans Clinical Research, Knoxville, Tennessee, United States
Clear Lake Specialties, Webster, Texas, United States
University of Wisconsin, Madison, Wisconsin, United States
Contact Details
Name: Ramzi Melhem, MD
Affiliation: Sensei Biotherapeutics
Role: STUDY_DIRECTOR
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