Summary of Study ST002110
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 | ST002110 |
| 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 2) |
| 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 | NA | Pre |
|---|---|---|---|
| SA202402 | BW48-38 | NA | Post |
| SA202403 | BW48-39 | NA | Post |
| SA202404 | BW48-40 | NA | Post |
| SA202405 | BW48-37 | NA | Pre |
| SA202406 | BW48-36 | NA | Pre |
| SA202433 | BW48-1 | non-responder | Post |
| SA202434 | BW48-5 | non-responder | Post |
| SA202435 | BW48-29 | non-responder | Post |
| SA202436 | BW48-7 | non-responder | Post |
| SA202437 | BW48-25 | non-responder | Post |
| SA202438 | BW48-4 | non-responder | Pre |
| SA202439 | BW48-6 | non-responder | Pre |
| SA202440 | BW48-28 | non-responder | Pre |
| SA202441 | BW48-24 | non-responder | Pre |
| SA202407 | BW48-13 | Responder | Post |
| SA202408 | BW48-15 | Responder | Post |
| SA202409 | BW48-11 | Responder | Post |
| SA202410 | BW48-9 | Responder | Post |
| SA202411 | BW48-3 | Responder | Post |
| SA202412 | BW48-17 | Responder | Post |
| SA202413 | BW48-21 | Responder | Post |
| SA202414 | BW48-33 | Responder | Post |
| SA202415 | BW48-35 | Responder | Post |
| SA202416 | BW48-19 | Responder | Post |
| SA202417 | BW48-31 | Responder | Post |
| SA202418 | BW48-27 | Responder | Post |
| SA202419 | BW48-23 | Responder | Post |
| SA202420 | BW48-30 | Responder | Pre |
| SA202421 | BW48-32 | Responder | Pre |
| SA202422 | BW48-34 | Responder | Pre |
| SA202423 | BW48-26 | Responder | Pre |
| SA202424 | BW48-18 | Responder | Pre |
| SA202425 | BW48-8 | Responder | Pre |
| SA202426 | BW48-2 | Responder | Pre |
| SA202427 | BW48-22 | Responder | Pre |
| SA202428 | BW48-10 | Responder | Pre |
| SA202429 | BW48-12 | Responder | Pre |
| SA202430 | BW48-20 | Responder | Pre |
| SA202431 | BW48-16 | Responder | Pre |
| SA202432 | BW48-14 | Responder | Pre |
| Showing results 1 to 40 of 40 |
