Clinical trial · Observational
Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer
Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies, Head and Neck Squamous Cell Cancer, Study 2
NCT05296135CI-TRIAL-00104094PREDAPT-HNSCC2withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients were recruited or enrolled in this study.
Summary
Brief summary (as posted)
This study will investigate the clinical validity and clinical utility of the OncoPrism-HNSCC (Head and Neck Squamous Cell Carcinoma) test.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OncoPrism-HNSCC™ | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Main Cohort
- interventionNames
- Diagnostic Test: OncoPrism-HNSCC™
Primary outcomes (1)
- measure
- Disease Control Rate: Inter-interval
- timeFrame
- through Final Analysis cutoff date of Dec 1, 2023
- description
- Inequality comparison of the linearly increasing Disease Control Rate of patients assigned to OncoPrism-HNSCC quarters 1, 2, 3, and 4.
Secondary outcomes (2)
- measure
- Disease Control Rate: Inter-interval 2
- timeFrame
- through Final Analysis cutoff date of Dec 1, 2023
- description
- Inequality comparison of the Disease Control Rate of patients assigned to OncoPrism-HNSCC intervals 1 and 2 versus 3 and 4.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTFlanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, McLeod HL, Westra WH, Vavinskaya V, Sutton L, Deichaite I, Macdonald OK, Welaya K, Wade J 3rd, Azzi G, Pippas AW, Slim J, Bank B, Sui X, Kossman SE, Shenkenberg TD, Alexander WL, Price KA, Ley J, Messina DN, Glasscock JI, Colevas AD, Cohen EEW, Adkins D, Duncavage EJ. Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study. J Immunother Cancer. 2024 Nov 3;12(11):e009573. doi: 10.1136/jitc-2024-009573. PMID 39489541