Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer
NCT03468218 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-01-23
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.
Conditions
- Metastatic Head and Neck Carcinoma
- Paranasal Sinus Squamous Cell Carcinoma
- Recurrent Head and Neck Squamous Cell Carcinoma
- Recurrent Hypopharyngeal Squamous Cell Carcinoma
- Recurrent Laryngeal Squamous Cell Carcinoma
- Recurrent Oral Cavity Squamous Cell Carcinoma
- Recurrent Oropharyngeal Squamous Cell Carcinoma
- Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVC Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Unresectable Head and Neck Squamous Cell Carcinoma
Interventions
- DRUG
-
Given PO
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
- collaborator INDUSTRY
-
National Institutes of Health (NIH)
collaborator NIH -
National Cancer Institute (NCI)
collaborator NIH -
Emory University
lead OTHER
Principal Investigators
-
Nabil F. Saba, MD · Emory University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-18
- Primary Completion
- 2022-05-02
- Completion
- 2026-10-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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