Status:
WITHDRAWN
Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer
Lead Sponsor:
Cofactor Genomics, Inc.
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05296135
Start Date
February 5 2020
End Date
February 20 2025
Last Update
March 13 2025
Active Locations (1)
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1
Curebase
San Francisco, California, United States, 94131