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NCT03565783 · ClinicalTrials.gov registry record · Phase 2
Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery
A Phase 2 study of Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT03565783: Active Phase 2 study of Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03565783 is a Phase 2 study of Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03565783, a Phase 2 study of Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck and Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well cemiplimab works before surgery in treating patients with stage II-IV head and neck cutaneous squamous cell cancer that has come back (recurrent) and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, 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
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Conditions Studied
Interventions
- BIOLOGICAL Cemiplimab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2018-07-03 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03565783 still lists
NCT03565783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 5 conditions, with Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 1 intervention - of which Cemiplimab is the first listed.
NCT03565783 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03565783 about?
NCT03565783 is a clinical study titled "Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery". This phase II trial studies how well cemiplimab works before surgery in treating patients with stage II-IV head and neck cutaneous squamous cell cancer that has come back (recurrent) and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help th...
What is the current status of trial NCT03565783?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2018-07-03. Estimated completion is 2027-12-31.
What conditions does trial NCT03565783 study?
This clinical trial studies the following conditions: Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck, Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8.
What interventions are being tested in trial NCT03565783?
The interventions under investigation include: Cemiplimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03565783?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03565783 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03565783's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
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