Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05296135
Status:
WITHDRAWN
Last Update Posted:
2025-03-13
First Post:
2022-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer
Sponsor:
Cofactor Genomics, Inc.
Organization:
Study Overview
Official Title:
Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies, Head and Neck Squamous Cell Cancer, Study 2
Status:
WITHDRAWN
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients were recruited or enrolled in this study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDAPT-HNSCC2
Brief Summary:
This study will investigate the clinical validity and clinical utility of the OncoPrism-HNSCC (Head and Neck Squamous Cell Carcinoma) test.
Detailed Description:
Patient outcomes would be improved if the available molecular diagnostics for predicting response to immunotherapy, namely PD-L1 immunohistochemistry (IHC) scoring, had greater accuracy in predicting tumor response. While PD-L1 expression in tumor specimens roughly correlates with benefit from immunotherapy, the predictive value of PD-L1 expression is low.
To address these weaknesses, new diagnostic methods are needed to accurately predict patient benefit from immunotherapy. As part of this effort, the investigators propose to evaluate the Cofactor OncoPrism-HNSCC™ assay.
The OncoPrism-HNSCC test is a qualitative Next Generation Sequencing (NGS)-based messenger ribonucleic acid (mRNA) gene expression profiling test system intended for use with FFPE tumor tissue to identify and analyze onco-immune phenotype molecular signatures and generate a prognostic score and classifier for previously diagnosed patients considered for treatment with immunotherapy.
Given a pre-treatment FFPE tumor specimen, OncoPrism-HNSCC™ (OP) Laboratory Derived Test (LDT) reports on a OncoPrism Score (OPS) for each patient. The test results assign patients to 1 of 4 intervals depending on the patient's OPS, with higher scores, and higher intervals correlating to higher immunotherapy efficacy. This study will measure the clinical outcomes of patients according to each interval.
The investigators hypothesize that the results from this study will show that the OncoPrism-HNSCC test is prognostic of the efficacy of immunotherapy. Specifically, the investigators hypothesize that clinical outcomes will be better for those patients who are assigned to higher intervals, according to the test.
To address these weaknesses, new diagnostic methods are needed to accurately predict patient benefit from immunotherapy. As part of this effort, the investigators propose to evaluate the Cofactor OncoPrism-HNSCC™ assay.
The OncoPrism-HNSCC test is a qualitative Next Generation Sequencing (NGS)-based messenger ribonucleic acid (mRNA) gene expression profiling test system intended for use with FFPE tumor tissue to identify and analyze onco-immune phenotype molecular signatures and generate a prognostic score and classifier for previously diagnosed patients considered for treatment with immunotherapy.
Given a pre-treatment FFPE tumor specimen, OncoPrism-HNSCC™ (OP) Laboratory Derived Test (LDT) reports on a OncoPrism Score (OPS) for each patient. The test results assign patients to 1 of 4 intervals depending on the patient's OPS, with higher scores, and higher intervals correlating to higher immunotherapy efficacy. This study will measure the clinical outcomes of patients according to each interval.
The investigators hypothesize that the results from this study will show that the OncoPrism-HNSCC test is prognostic of the efficacy of immunotherapy. Specifically, the investigators hypothesize that clinical outcomes will be better for those patients who are assigned to higher intervals, according to the test.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: