Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer (PREDAPT-HNSCC2)

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

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Diagnostic test: OncoPrism-HNSCC™

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94131
      • Recruiting
      • Curebase
      • Contact: Arsheen Ali; Phone Number: 626-483-9418; Email: arsheen@curebase.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Recurrent and metastatic Head and Neck Squamous Cell Carcinoma patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.

Description

Inclusion Criteria:

1. Subject must have been diagnosed with recurrent or metastatic HNSCC.
2. 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.
3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
4. Subject must have a RECIST determination of PD-L1/PD-1 inhibitor-treatment by imaging or clinical assessment.
5. Willing to provide electronic informed consent per IRB-approved protocol.
6. Able to speak, read, and comprehend English or Spanish fluently.
7. Subject is 18 years of age or older.
8. 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:

1. Subject shall not have received immunotherapy in combination with other therapy modality such as radiation therapy, platinum-based chemotherapy, or a taxane.
2. Subject shall not have received immunotherapy outside of FDA approved use as of the date of this protocol.
3. Subject shall not have inability or unwillingness to provide informed consent.
4. Subject shall not have other cancers than listed above (other histologies).
5. Subject shall not have already participated in this trial.
6. Subject specimens shall not have <10% tumor cellularity measured by H&E.
7. More than 24 months shall not have transpired between biopsy harvest and studied immunotherapy treatment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main Cohort	Diagnostic test: OncoPrism-HNSCC™; OncoPrism-HNSCC™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cofactor Genomics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasms, Squamous Cell
• Other Study ID Numbers: PREDAPT-HNSCC-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No