Head and Neck Squamous Cell CarcinomaPREDAPT-HNSCC2NCT05296135
Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer
An observational study of Head and Neck Squamous Cell Carcinoma, run by Cofactor Genomics, Inc. at 1 site in United States.
Trial summary
This study will investigate the clinical validity and clinical utility of the OncoPrism-HNSCC (Head and Neck Squamous Cell Carcinoma) test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- OncoPrism-HNSCC™
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2020to 20 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recurrent and metastatic Head and Neck Squamous Cell Carcinoma patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 tumor response. While PD-L1 expression in tumor specimens roughly correlates with benefit from immunotherapy, the predictive value of PD-L1 expression is low.
To address these weaknesses, new diagnostic methods are needed to accurately predict patient benefit from immunotherapy. As part of this effort, the investigators propose to evaluate the Cofactor OncoPrism-HNSCC™ assay.
The OncoPrism-HNSCC test is a qualitative Next Generation Sequencing (NGS)-based messenger ribonucleic acid (mRNA) gene expression profiling test system intended for use with FFPE tumor tissue to identify and analyze onco-immune phenotype molecular signatures and generate a prognostic score and classifier for previously diagnosed patients considered for treatment with immunotherapy.
Given a pre-treatment FFPE tumor specimen, OncoPrism-HNSCC™ (OP) Laboratory Derived Test (LDT) reports on a OncoPrism Score (OPS) for each patient. The test results assign patients to 1 of 4 intervals depending on the patient's OPS, with higher scores, and higher intervals correlating to higher immunotherapy efficacy. This study will measure the clinical outcomes of patients according to each interval.
The investigators hypothesize that the results from this study will show that the OncoPrism-HNSCC test is prognostic of the efficacy of immunotherapy. Specifically, the investigators hypothesize that clinical outcomes will be better for those patients who are assigned to higher intervals, according to the test.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- OncoPrism-HNSCC™
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoPrism-HNSCC™Diagnostic test
OncoPrism-HNSCC™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | Not described Receives: Diagnostic Test: OncoPrism-HNSCC™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate: Inter-interval
Inequality comparison of the linearly increasing Disease Control Rate of patients assigned to OncoPrism-HNSCC quarters 1, 2, 3, and 4.
Measured: through Final Analysis cutoff date of Dec 1, 2023
Secondary outcomes (2)
Disease Control Rate: Inter-interval 2
Inequality comparison of the Disease Control Rate of patients assigned to OncoPrism-HNSCC intervals 1 and 2 versus 3 and 4.
Measured: through Final Analysis cutoff date of Dec 1, 2023
Sensitivity: OncoPrism-HNSCC vs PD-L1 IHC
Non-inferior comparison of the sensitivity of OncoPrism-HNSCC, using a binary threshold between intervals 2 and 3, versus PD-L1 IHC, using a binary threshold at CPS of 20.
Measured: through Final Analysis cutoff date of Dec 1, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start5 Feb 2020
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Why it stopped: No patients were recruited or enrolled in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cofactor Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296135
- Sponsor's protocol ID
- PREDAPT-HNSCC-2
- Acronym
- PREDAPT-HNSCC2
- Status last verified
- Feb 2026
- First submitted
- 7 Mar 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Flanagan 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.
PubMed 39489541
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies, Head and Neck Squamous Cell Cancer, Study 2
- ClinicalTrials.gov ID
- NCT05296135
- Acronym / sponsor ID
- PREDAPT-HNSCC2 / PREDAPT-HNSCC-2
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients were recruited or enrolled in this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cofactor Genomics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 tumor response. While PD-L1 expression in tumor specimens roughly correlates with benefit from immunotherapy, the predictive value of PD-L1 expression is low.
To address these weaknesses, new diagnostic methods are needed to accurately predict patient benefit from immunotherapy. As part of this effort, the investigators propose to evaluate the Cofactor OncoPrism-HNSCC™ assay.
The OncoPrism-HNSCC test is a qualitative Next Generation Sequencing (NGS)-based messenger ribonucleic acid (mRNA) gene expression profiling test system intended for use with FFPE tumor tissue to identify and analyze onco-immune phenotype molecular signatures and generate a prognostic score and classifier for previously diagnosed patients considered for treatment with immunotherapy.
Given a pre-treatment FFPE tumor specimen, OncoPrism-HNSCC™ (OP) Laboratory Derived Test (LDT) reports on a OncoPrism Score (OPS) for each patient. The test results assign patients to 1 of 4 intervals depending on the patient's OPS, with higher scores, and higher intervals correlating to higher immunotherapy efficacy. This study will measure the clinical outcomes of patients according to each interval.
The investigators hypothesize that the results from this study will show that the OncoPrism-HNSCC test is prognostic of the efficacy of immunotherapy. Specifically, the investigators hypothesize that clinical outcomes will be better for those patients who are assigned to higher intervals, according to the test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | – | Diagnostic Test: OncoPrism-HNSCC™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recurrent and metastatic Head and Neck Squamous Cell Carcinoma patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncoPrism-HNSCC™OncoPrism-HNSCC™ is a new approach to characterizing the immune component of pre-treatment tumor tissue. | Diagnostic test | Main Cohort |
Primary outcome
Disease Control Rate: Inter-interval
Time frame: through Final Analysis cutoff date of Dec 1, 2023
Inequality comparison of the linearly increasing Disease Control Rate of patients assigned to OncoPrism-HNSCC quarters 1, 2, 3, and 4.
2 secondary outcomes
Disease Control Rate: Inter-interval 2
Time frame: through Final Analysis cutoff date of Dec 1, 2023
Sensitivity: OncoPrism-HNSCC vs PD-L1 IHC
Time frame: through Final Analysis cutoff date of Dec 1, 2023
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Results publication: PubMed 39489541Flanagan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by Cofactor Genomics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate: Inter-interval (time frame: through Final Analysis cutoff date of Dec 1, 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.