Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer
Withdrawn before enrolling
Conditions studied: Head and Neck Squamous Cell Carcinoma
In brief
This study will investigate the clinical validity and clinical utility of the OncoPrism-HNSCC (Head and Neck Squamous Cell Carcinoma) test.
Key facts
- Study ID
- NCT05296135
- Run by
- Cofactor Genomics, Inc.
- People needed
- 0
- Starts
- 2020-02-05
- Expected to finish
- 2025-02-20
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Curebase — San Francisco, California, United States
Full record on ClinicalTrials.gov
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