Pembrolizumab & Cabozantinib 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib — DRUG
  Given PO
• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Sep 18, 2018

Status verified

Jan 2026

Primary completion

May 2, 2022

Completion

Oct 29, 2026

Study Design

Enrollment

36 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (pembrolizumab, cabozantinib)
  Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 2 years after treatment start ]

Locations (2)

Find similar trials in Tampa, FL

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