Cancer of Head and NeckNCT04510129
A Multicenter Cancer Biospecimen Collection Study
An observational study of Cancer of Head and Neck and Lung Cancer, Nonsmall Cell, run by Cofactor Genomics, Inc. at 1 site in United States.
Trial summary
This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck, Lung Cancer, Nonsmall Cell, Small-cell Lung Cancer
- What is being tested?
- OncoPrism™ assay
- How many people
- 1,650 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2020to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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 a disease of interest. Specifically, subject must have one of:
- head and neck squamous cell carcinoma (HNSCC)
- non-small-cell lung cancer (NSCLC)
- small cell lung cancer (SCLC)
- urothelial carcinoma (UCC)
- gastric or gastroesophageal junction adenocarcinoma
Show all 19Show fewer
- cervical cancer
- esophageal squamous cell carcinoma (ESCC)
- triple-negative breast cancer (TNBC)
- hepatocellular carcinoma (HCC)
- renal cell carcinoma (RCC)
- colorectal cancer (CRC)
- Subject must have received, or be scheduled to receive, at least one dose of 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 undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.
- Willing to provide electronic informed consent per IRB-approved protocol.
- Able to speak, read, and comprehend English fluently.
- Subject is 18 years of age or older.
- Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.
Who cannot join
- Inability or unwillingness to provide informed consent.
- Subject who does/did not have one of the cancers listed above (other histologies).
- Subject has already participated in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Curebase
San Francisco, California, 94131
Study Director, (628) 200-4082, predapthelp@curebase.com
About this study
Official title: Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies
This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.
Read the detailed description
This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1/PD-L1 inhibitors. 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.
The study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began.
Participants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.
- Conditions
- Cancer of Head and Neck, Lung Cancer, Nonsmall Cell, Small-cell Lung Cancer, Urothelial Carcinoma, Gastroesophageal Junction Adenocarcinoma, Cervical Cancer
- Being tested
- OncoPrism™ assay
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoma, Transitional Cell, Uterine Cervical Neoplasms, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoPrism™ assayDiagnostic test
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
| Study group | Role | What they receive |
|---|---|---|
| head and neck squamous cell carcinoma (HNSCC) | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| non-small-cell lung cancer (NSCLC) | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| small cell lung cancer (SCLC) | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| urothelial carcinoma (UCC) | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| gastric or gastroesophageal junction adenocarcinoma | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| cervical cancer | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| esophageal squamous cell carcinoma (ESCC) | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| triple-negative breast cancer (TNBC) | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| hepatocellular carcinoma (HCC) | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| renal cell carcinoma (RCC) | Not described Receives: Diagnostic Test: OncoPrism™ assay | |
| colorectal cancer (CRC) | Not described Receives: Diagnostic Test: OncoPrism™ assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD-L1/PD-1 inhibitor response
No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start5 Feb 2020
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer of Head and NeckStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cofactor Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Responsible party
- Sponsor
- Investigators
- Jarret Glasscock, Study director, Cofactor Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510129
- Sponsor's protocol ID
- PREDAPT
- Status last verified
- Mar 2025
- First submitted
- 10 Aug 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, Pemberton K, Macdonald OK, Welaya K, Pippas AW, D'Silva K, Sui X, Alexander WL, Slim J, Saccaro SJ, Shenkenberg TD, Bailey SD, Sonnier SA, Azzi G, Bank B, Kossman SE, Gonzales P, Wade J 3rd, Hellyer JA, McLeod HL, Duncavage EJ, Glasscock JI. Validation of a tissue-based predictive RNA test for immunotherapy benefit in NSCLC: the PREDAPT study. NPJ Precis Oncol. 2026 Jul 29;10(1):369. doi: 10.1038/s41698-026-01632-6.
PubMed 42834100Flanagan 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 12 Mar 2025. 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
- ClinicalTrials.gov ID
- NCT04510129
- Acronym / sponsor ID
- PREDAPT
- Conditions
- Cancer of Head and Neck, Lung Cancer, Nonsmall Cell, Small-cell Lung Cancer, Urothelial Carcinoma, Gastroesophageal Junction Adenocarcinoma, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Cofactor Genomics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Aug 2020 (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 collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.
Detailed description
This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1/PD-L1 inhibitors. 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.
The study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began.
Participants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| head and neck squamous cell carcinoma (HNSCC) | – | Diagnostic Test: OncoPrism™ assay |
| non-small-cell lung cancer (NSCLC) | – | Diagnostic Test: OncoPrism™ assay |
| small cell lung cancer (SCLC) | – | Diagnostic Test: OncoPrism™ assay |
| urothelial carcinoma (UCC) | – | Diagnostic Test: OncoPrism™ assay |
| gastric or gastroesophageal junction adenocarcinoma | – | Diagnostic Test: OncoPrism™ assay |
| cervical cancer | – | Diagnostic Test: OncoPrism™ assay |
| esophageal squamous cell carcinoma (ESCC) | – | Diagnostic Test: OncoPrism™ assay |
| triple-negative breast cancer (TNBC) | – | Diagnostic Test: OncoPrism™ assay |
| hepatocellular carcinoma (HCC) | – | Diagnostic Test: OncoPrism™ assay |
| renal cell carcinoma (RCC) | – | Diagnostic Test: OncoPrism™ assay |
| colorectal cancer (CRC) | – | Diagnostic Test: OncoPrism™ assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 (19 listed)
- Subject must have a disease of interest. Specifically, subject must have one of:
- Subject must have received, or be scheduled to receive, at least one dose of 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 undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.
- Willing to provide electronic informed consent per IRB-approved protocol.
Key exclusion criteria (3 listed)
- Inability or unwillingness to provide informed consent.
- Subject who does/did not have one of the cancers listed above (other histologies).
- Subject has 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™ assayOncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue. | Diagnostic test | cervical cancer, colorectal cancer (CRC), esophageal squamous cell carcinoma (ESCC), gastric or gastroesophageal junction adenocarcinoma, head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), urothelial carcinoma (UCC) |
Primary outcome
PD-L1/PD-1 inhibitor response
Time frame: 6 months
No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 42834100Flanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, Pemberton K, Macdonald OK, Welaya K, Pippas AW, D'Silva K, Sui X, Alexander WL, Slim J, Saccaro SJ, Shenkenberg TD, Bailey SD, Sonnier SA, Azzi G, Bank B, Kossman SE, Gonzales P, Wade J 3rd, Hellyer JA, McLeod HL, Duncavage EJ, Glasscock JI. Validation of a tissue-based predictive RNA test for immunotherapy benefit in NSCLC: the PREDAPT study. NPJ Precis Oncol. 2026 Jul 29;10(1):369. doi: 10.1038/s41698-026-01632-6.
- Derived from this study: 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.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jarret Glasscock study director
Cofactor Genomics
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 Cancer of Head and Neck and Lung Cancer, Nonsmall Cell, 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 19 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Coordinator ((888) 602-0448, clinicaltrials@cofactorgenomics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD-L1/PD-1 inhibitor response (time frame: 6 months). 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 NCT04510129, which also lists 2 linked publications.
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 12 Mar 2025.