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NCT04375384 · ClinicalTrials.gov registry record · Phase 2
Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
A Phase 2 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04375384: Recruiting Phase 2 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, sponsored by Wake Forest University Health Sciences.
NCT04375384 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 38 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04375384, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.
Primary Outcome
Overall response rate is defined as the proportion patients achieving partial response or complete response per RECIST v1.1 criteria. An estimate of a 95% Exact Clopper Pearson confidence interval will be used. RECIST 1.1 criteria will be used to measure tumor size: Measurable disease is defined by the presence of at least 1 measurable lesion. A lesion, not previously irradiated per the protocol prior to enrollment, that can be accurately measured at baseline as ≥10 mm in the longest diameter (e
Conditions Studied
Interventions
- DRUG Cetuximab
- OTHER Questionnaire administration
- OTHER Quality of life assessment
Study Locations (1)
North Carolina
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT04375384 shows while recruiting
NCT04375384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (68% lower).
The record links to 3 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cetuximab is the first listed.
NCT04375384 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04375384 about?
NCT04375384 is a clinical study titled "Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer". This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemoth...
What is the current status of trial NCT04375384?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2020-07-01. Estimated completion is 2027-12.
What conditions does trial NCT04375384 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04375384?
The interventions under investigation include: Cetuximab (DRUG), Questionnaire administration (OTHER), Quality of life assessment (OTHER).
Who is sponsoring clinical trial NCT04375384?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04375384 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04375384's enrollment target sits among peer trials
38 81st of 124 higher than 44 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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