Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT05296135
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05296135
Study Brief:
Protocol Section:
NCT05296135