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NCT03144778 · ClinicalTrials.gov registry record · Phase 1
Durvalumab With or Without Tremelimumab in Treating Participants With Stage II-IVA Oropharyngeal Squamous Cell Cancer
A Phase 1 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT03144778: Completed Phase 1 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
NCT03144778 is a Phase 1 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 39 participants, below the 234-participant average among 5 other Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03144778, a Phase 1 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies how well durvalumab with or without tremelimumab works in treating participants with stage II-IVA oropharyngeal squamous cell cancer. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Change will be defined as the ratio of the CD8+ lymphocytes density in the post-treatment surgical specimens over the CD8+ density in the baseline biopsy before treatment.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- BIOLOGICAL Tremelimumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2017-07-12 |
| Est. Completion | 2021-03-15 |
| Phase | Phase 1 |
What the finished NCT03144778 record still lists
NCT03144778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 234-participant average among 5 other Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT03144778 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03144778 about?
NCT03144778 is a clinical study titled "Durvalumab With or Without Tremelimumab in Treating Participants With Stage II-IVA Oropharyngeal Squamous Cell Cancer". This phase I trial studies how well durvalumab with or without tremelimumab works in treating participants with stage II-IVA oropharyngeal squamous cell cancer. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may...
What is the current status of trial NCT03144778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2017-07-12. Estimated completion is 2021-03-15.
What conditions does trial NCT03144778 study?
This clinical trial studies the following conditions: Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage II Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7.
What interventions are being tested in trial NCT03144778?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03144778?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03144778 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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