Summary of Study ST002109
This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench, https://www.metabolomicsworkbench.org, 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.
See: https://www.metabolomicsworkbench.org/about/howtocite.php
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.
| Study ID | ST002109 |
| Study Title | Towards 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 1) |
| Study Summary | Five-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. |
| Institute | University of Colorado Denver |
| Last Name | Culp-Hill |
| First Name | Rachel |
| Address | 12801 E 17th Ave L18-9403D, Aurora, Colorado, 80045, USA |
| rachel.hill@cuanschutz.edu | |
| Phone | 303-724-5798 |
| Submit Date | 2022-03-09 |
| Raw Data Available | Yes |
| Raw Data File Type(s) | mzXML |
| Analysis Type Detail | LC-MS |
| Release Date | 2022-04-04 |
| Release Version | 1 |
Select appropriate tab below to view additional metadata details:
Factors:
Subject type: Human; Subject species: Homo sapiens (Factor headings shown in green)
| mb_sample_id | local_sample_id | Phenotype | Treatment |
|---|---|---|---|
| SA202361 | BW45-39 | NA | Post |
| SA202362 | BW45-40 | NA | Post |
| SA202363 | BW45-38 | NA | Post |
| SA202364 | BW45-41 | NA | Pre |
| SA202365 | BW45-37 | NA | Pre |
| SA202366 | BW45-36 | NA | Pre |
| SA202393 | BW45-1 | non-responder | Post |
| SA202394 | BW45-5 | non-responder | Post |
| SA202395 | BW45-29 | non-responder | Post |
| SA202396 | BW45-7 | non-responder | Post |
| SA202397 | BW45-25 | non-responder | Post |
| SA202398 | BW45-4 | non-responder | Pre |
| SA202399 | BW45-6 | non-responder | Pre |
| SA202400 | BW45-28 | non-responder | Pre |
| SA202401 | BW45-24 | non-responder | Pre |
| SA202367 | BW45-13 | Responder | Post |
| SA202368 | BW45-15 | Responder | Post |
| SA202369 | BW45-11 | Responder | Post |
| SA202370 | BW45-17 | Responder | Post |
| SA202371 | BW45-3 | Responder | Post |
| SA202372 | BW45-9 | Responder | Post |
| SA202373 | BW45-23 | Responder | Post |
| SA202374 | BW45-33 | Responder | Post |
| SA202375 | BW45-35 | Responder | Post |
| SA202376 | BW45-19 | Responder | Post |
| SA202377 | BW45-31 | Responder | Post |
| SA202378 | BW45-27 | Responder | Post |
| SA202379 | BW45-21 | Responder | Post |
| SA202380 | BW45-30 | Responder | Pre |
| SA202381 | BW45-32 | Responder | Pre |
| SA202382 | BW45-34 | Responder | Pre |
| SA202383 | BW45-26 | Responder | Pre |
| SA202384 | BW45-16 | Responder | Pre |
| SA202385 | BW45-8 | Responder | Pre |
| SA202386 | BW45-2 | Responder | Pre |
| SA202387 | BW45-22 | Responder | Pre |
| SA202388 | BW45-10 | Responder | Pre |
| SA202389 | BW45-12 | Responder | Pre |
| SA202390 | BW45-20 | Responder | Pre |
| SA202391 | BW45-18 | Responder | Pre |
| SA202392 | BW45-14 | Responder | Pre |
| Showing results 1 to 41 of 41 |
