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NCT03468218 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer
A Phase 2 study of Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, sponsored by Emory University.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT03468218: Active Phase 2 study of Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, sponsored by Emory University.
NCT03468218 is a Phase 2 study of Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma that is active but no longer recruiting, run by Emory University. The registered enrollment target is 36 participants, below the 119-participant average among 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (70% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03468218, a Phase 2 study of Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well pembrolizumab and cabozantinib in treating patients with head and neck squamous cell cancer that has come back or spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the pathways needed for cell growth. Giving pembrolizumab and cabozantinib may improve the chances of tumor response in patients with head and neck squamous cell cancer.
Primary Outcome
Will assess the proportion of subjects with partial response or complete response as defined by Response Evaluation Criteria in Solid Tumors version 1.1 response criteria. ORR will be calculated with 95% confidence interval by binomial distribution. The ability of biomarkers to predict ORR will be estimated by chi-square test and/or logistic regression model.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cabozantinib
Study Locations (2)
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Emory University Hospital Midtown - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2026-10-29 |
| Phase | Phase 2 |
What the registry record for NCT03468218 still lists
NCT03468218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 119-participant average among 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (70% lower).
The record links to 10 conditions, with Recurrent Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03468218 reports a single indexed study location in Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03468218 about?
NCT03468218 is a clinical study titled "Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer". This phase II trial studies how well pembrolizumab and cabozantinib in treating patients with head and neck squamous cell cancer that has come back or spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of ...
What is the current status of trial NCT03468218?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2018-09-18. Estimated completion is 2026-10-29.
What conditions does trial NCT03468218 study?
This clinical trial studies the following conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Metastatic Head and Neck Carcinoma.
What interventions are being tested in trial NCT03468218?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT03468218?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03468218 being conducted?
This trial has 2 study locations across Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Head and Neck Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03468218's enrollment target sits among peer trials
36 16th of 24 higher than 9 of 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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