Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer
Reason given: No patients were recruited or enrolled in this study.
Key facts
- Where
- San Francisco, United StatesSee the site
Where in United States
- CurebaseSan Francisco, United StatesNo longer taking part
Trial details
- Who runs it
- Cofactor Genomics, Inc.
- Trial code
- NCT05296135
- Record updated
- 27 February 2026
- Original description
This study will investigate the clinical validity and clinical utility of the OncoPrism-HNSCC (Head and Neck Squamous Cell Carcinoma) test.Read full original descriptionShow less
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.
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; More than 24 months shall not have transpired between biopsy harvest and studied immunotherapy treatment; Subject shall not have other cancers than listed above (other histologies); Subject shall not have inability or unwillingness to provide informed consent; Subject shall not have already participated in this trial; Subject specimens shall not have <10% tumor cellularity measured by H\&E.