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NCT04015336 · ClinicalTrials.gov registry record · Phase 2
E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04015336: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT04015336 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04015336, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: The therapy used in this study is called E7 T-cell receptor (TCR) T cell therapy. This therapy is a type of treatment in which a participant's T cells (a type of immune system cell) are changed in the laboratory to attack cancer cells. This treatment might help people with human papillomavirus (HPV)-associated oropharyngeal cancer. Oropharyngeal cancer is a type of head and neck cancer that happens in the oropharynx (the part of the throat at the back of the mouth, including the soft palate, the base of the tongue, and the tonsils). Certain types of the HPV virus can cause this kind of cancer. This study is looking at treatments for cancer caused by HPV-16. Objective: The purpose of this study is to determine if E7 TCR T cells can be given safely without delaying standard treatment for HPV-16 associated oropharyngeal cancer. Standard treatment may be surgery or radiation therapy with chemotherapy. Eligibility: People ages 18 and older with Stage II or III HPV-16 associated oropharyngeal cancer Design: Participants will be screened with HLA typing (a blood test needed for eligibility) and HPV testing of the cancer tumor (to determine if the cancer is HPV-16 positive). A new biopsy may be needed if tumor from an outside location is not available for HPV testing. Eligible participants will come to the National Institutes of Health (NIH) campus to have a screening evaluation which will include physical exam, review of medical history and current medications, blood and heart tests, imaging (X-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI) or positron emission tomography (PET) scan), and evaluation of participant's veins that are used for drawing blood. If the participant is eligible for the study based on the screening evaluation, they will have a baseline evaluation prior to receiving the experimental treatment. The baseline evaluation may include additional laboratory or imaging tests. Participants will have a large intravenous
Interventions
- BIOLOGICAL E7 T-Cell Receptor (TCR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04015336
The ClinicalTrials.gov registry entry for NCT04015336 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which E7 T-Cell Receptor (TCR) is the first listed.
NCT04015336 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04015336 about?
NCT04015336 is a clinical study titled "E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer". Background: The therapy used in this study is called E7 T-cell receptor (TCR) T cell therapy. This therapy is a type of treatment in which a participant's T cells (a type of immune system cell) are changed in the laboratory to attack cancer cells. This treatment might help people with human papillo...
What is the current status of trial NCT04015336?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2020-07-06. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT04015336?
The interventions under investigation include: E7 T-Cell Receptor (TCR) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04015336?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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