Summary of Study ST002110

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench,, where it has been assigned Project ID PR001336. The data can be accessed directly via it's Project DOI: 10.21228/M81D70 This work is supported by NIH grant, U2C- DK119886.


This study contains a large results data set and is not available in the mwTab file. It is only available for download via FTP as data file(s) here.

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Study IDST002110
Study TitleTowards a mechanistic understanding of patient response to neoadjuvant SBRT with anti-PDL1 in human HPV-unrelated locally advanced HNSCC: Phase I/Ib trial results (Part 2)
Study SummaryFive-year survival for HPV-unrelated head and neck squamous cell carcinomas (HNSCC) remains below 50%. We assessed the safety of administering combination hypofractionated stereotactic body radiation therapy (SBRT) with anti-PDL-1 neoadjuvantly followed by adjuvant anti-PDL-1 with standard of care therapy (n=21). The primary endpoint of the study was safety, which was met. Secondary endpoints included radiographic, pathologic, and objective response, locoregional control (LRC), progression-free survival (PFS), and overall survival (OS). Among evaluable patients at early median follow-up of 16 months (448 days), OS was 83.3%, LRC and PFS were 83.3%, and major pathological response (MPR) or complete response (CR) was 75%. Circulating CD8/Treg ratio, CD4 effector memory T cells, and TCR repertoire emerged as biologic correlates of response to therapy. Using high-dimensional multi-omics and spatial data as well as biological correlatives pre- and post-treatment, three major changes were noted in responders within the tumor microenvironment (TME) (and within the blood) post-treatment: 1) an increase in effector T cells; 2) a decrease in immunosuppressive cells; and 3) an increase in antigen presentation. Non-responders appeared to fail due to a lack of one of these three identified steps needed for priming and maintaining activation of T cells. Multiple correlates for response, along with subsets of non-responders that may benefit from additional or alternative immunotherapies, were identified. This treatment is being tested in an ongoing phase II trial with a similar design, where we hope to confirm and expand on our understanding of the mechanisms underlying resistance to therapy.
University of Colorado Denver
Last NameCulp-Hill
First NameRachel
Address12801 E 17th Ave L18-9403D, Aurora, Colorado, 80045, USA
Submit Date2022-03-09
Raw Data AvailableYes
Raw Data File Type(s)mzXML
Analysis Type DetailLC-MS
Release Date2022-04-04
Release Version1
Rachel Culp-Hill Rachel Culp-Hill application/zip

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Subject type: Human; Subject species: Homo sapiens (Factor headings shown in green)

mb_sample_id local_sample_id NA Pre
SA202402BW48-38NA Post
SA202403BW48-39NA Post
SA202404BW48-40NA Post
SA202405BW48-37NA Pre
SA202406BW48-36NA Pre
SA202433BW48-1non-responder Post
SA202434BW48-5non-responder Post
SA202435BW48-29non-responder Post
SA202436BW48-7non-responder Post
SA202437BW48-25non-responder Post
SA202438BW48-4non-responder Pre
SA202439BW48-6non-responder Pre
SA202440BW48-28non-responder Pre
SA202441BW48-24non-responder Pre
SA202407BW48-13Responder Post
SA202408BW48-15Responder Post
SA202409BW48-11Responder Post
SA202410BW48-9Responder Post
SA202411BW48-3Responder Post
SA202412BW48-17Responder Post
SA202413BW48-21Responder Post
SA202414BW48-33Responder Post
SA202415BW48-35Responder Post
SA202416BW48-19Responder Post
SA202417BW48-31Responder Post
SA202418BW48-27Responder Post
SA202419BW48-23Responder Post
SA202420BW48-30Responder Pre
SA202421BW48-32Responder Pre
SA202422BW48-34Responder Pre
SA202423BW48-26Responder Pre
SA202424BW48-18Responder Pre
SA202425BW48-8Responder Pre
SA202426BW48-2Responder Pre
SA202427BW48-22Responder Pre
SA202428BW48-10Responder Pre
SA202429BW48-12Responder Pre
SA202430BW48-20Responder Pre
SA202431BW48-16Responder Pre
SA202432BW48-14Responder Pre
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