Study on Pembrolizumab and Cabozantinib for Head and Neck Squamous Cell Cancer
Sponsor: Emory University
ClinicalTrials ID:NCT03468218
This clinical trial is exploring the effectiveness of combining pembrolizumab and cabozantinib to treat head and neck squamous cell cancer that has returned or spread and cannot be removed by surgery. The study aims to see if this combination can improve tumor response.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This phase II study is testing how well the drugs pembrolizumab and cabozantinib work together in treating patients with head and neck squamous cell cancer that has come back or spread to other parts of the body and cannot be surgically removed. Pembrolizumab is a monoclonal antibody that may help stop tumor cells from growing and spreading, while cabozantinib may block pathways needed for tumor cell growth. The goal is to see if using both drugs together can improve the chances of reducing the tumor size in these patients.
Description
The main goal of this study is to estimate how many patients with recurrent or metastatic squamous cell carcinoma of the head and neck respond to the combination of pembrolizumab and cabozantinib.
Secondary goals include estimating how long patients live without the cancer getting worse and understanding the side effects of these treatments.
Patients will receive pembrolizumab through an IV for 30 minutes on the first day and take cabozantinib by mouth once a day for 21 days. This cycle repeats every 3 weeks as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will be monitored for up to 2 years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with squamous cell carcinoma in areas like the mouth, throat, sinuses, or voice box. Cancer in neck lymph nodes can be included if HPV positive.
- Cancer must be recurrent, metastatic, and not operable.
- Must have shown disease progression after previous treatments.
- Must have measurable disease according to specific criteria.
- Allowed one prior radiotherapy to the head and neck, with specific time gaps since last treatment.
- Must have had recent scans of all known disease sites.
- Life expectancy of more than 3 months.
- Good overall health with a performance status of 0 or 1.
- Recovery from previous treatment side effects to a certain level.
- Specific blood counts and organ function levels must be met before starting treatment.
- Must understand and agree to the study requirements and sign informed consent.
- Must agree to use effective contraception during and after the study.
- Women must not be pregnant at the start of the study.
Exclusion Criteria
- HPV negative squamous cell carcinoma of unknown primary in neck lymph nodes.
- Recent chemotherapy or biologic agents within specified timeframes before starting the study.
- Previous treatment with cabozantinib or pembrolizumab.
- Recent radiation therapy or investigational treatments within specified timeframes.
- Known brain metastases unless treated and stable.
- Certain blood clotting issues or use of specific anticoagulants.
- Recent significant bleeding or signs of pulmonary hemorrhage.
- Tumor invading major blood vessels or gastrointestinal tract.
- Uncontrolled or significant recent illnesses, including heart or gastrointestinal disorders.
- Recent major surgery or incomplete healing from surgery.
- Certain heart rhythm issues.
- Pregnant or breastfeeding women.
- Inability to swallow tablets or take study medications.
- Allergy to study treatment components.
- History of other cancers unless treated and disease-free for a year.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Emory University Hospital Midtown | 30308 | Atlanta | Georgia |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.