Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer

Study Overview
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Brief Summary
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This study will investigate the clinical validity and clinical utility of the OncoPrism-HNSCC (Head and Neck Squamous Cell Carcinoma) test.

Detailed Description
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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.

Official Title
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Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies, Head and Neck Squamous Cell Cancer, Study 2

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Diagnostic Test: OncoPrism-HNSCC™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have been diagnosed with recurrent or metastatic HNSCC. Subject must have received, or be scheduled to receive, at least one dose of FDA approved anti-PD-1/PD-L1 immunotherapy for treatment of their cancer. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy. Subject must have a RECIST determination of PD-L1/PD-1 inhibitor-treatment by imaging or clinical assessment. Willing to provide electronic informed consent per IRB-approved protocol. Able to speak, read, and comprehend English or Spanish fluently. Subject is 18 years of age or older. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study, as defined in the Specimens to be Collected section of protocol. Exclusion Criteria: Subject shall not have received immunotherapy in combination with other therapy modality such as radiation therapy, platinum-based chemotherapy, or a taxane. Subject shall not have received immunotherapy outside of FDA approved use as of the date of this protocol. Subject shall not have inability or unwillingness to provide informed consent. Subject shall not have other cancers than listed above (other histologies). Subject shall not have already participated in this trial. Subject specimens shall not have <10% tumor cellularity measured by H&E. More than 24 months shall not have transpired between biopsy harvest and studied immunotherapy treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Cohort<br> | Diagnostic Test: OncoPrism-HNSCC™<br>* OncoPrism-HNSCC™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate: Inter-interval | Inequality comparison of the linearly increasing Disease Control Rate of patients assigned to OncoPrism-HNSCC quarters 1, 2, 3, and 4. | through Final Analysis cutoff date of Dec 1, 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate: Inter-interval 2 | Inequality comparison of the Disease Control Rate of patients assigned to OncoPrism-HNSCC intervals 1 and 2 versus 3 and 4. | through Final Analysis cutoff date of Dec 1, 2023 | 
| Sensitivity: OncoPrism-HNSCC vs PD-L1 IHC | Non-inferior comparison of the sensitivity of OncoPrism-HNSCC, using a binary threshold between intervals 2 and 3, versus PD-L1 IHC, using a binary threshold at CPS of 20. | through Final Analysis cutoff date of Dec 1, 2023 |