Phase II Study of Adding Pembrolizumab to Standard Treatment for Head and Neck Cancer After Surgery
Sponsor: Trisha Wise-Draper
ClinicalTrials ID:NCT02641093
This clinical trial is exploring whether adding pembrolizumab, a drug that helps the immune system fight cancer, to the usual treatment of surgery and radiation can improve outcomes for patients with head and neck cancer. Some patients may also receive the chemotherapy drug cisplatin if their cancer is considered high risk.
Patient Parameters
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Program Overview
The aim of this study is to determine if pembrolizumab, an immune-boosting drug, can enhance the effectiveness of the standard treatment for head and neck cancer, which includes surgery followed by six weeks of radiation. Patients with high-risk cancer, such as those with cancer not fully removed or that has spread to the outer lining of lymph nodes, may also receive the chemotherapy drug cisplatin once a week for six weeks.
Eligibility Criteria
Inclusion Criteria
- Eligible for surgery with one or more of the following conditions:
- Any tumor size with significant lymph node involvement (N2 or higher).
- Large tumors (T4) regardless of lymph node involvement.
- Tumors in the oral cavity that are moderately large (T3) regardless of lymph node involvement.
- Signs of cancer spreading beyond the lymph node capsule on scans.
- Willing to undergo surgery and neck dissection.
- Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Sufficient lab results and appropriate imaging for staging.
Exclusion Criteria
- Have an immune system deficiency or are taking medications that suppress the immune system within 7 days before starting the trial treatment.
- Have nasopharyngeal or sinonasal carcinoma.
- Have confirmed cancer that has spread to other parts of the body (metastatic disease).
- Have HPV-positive cancer of the oropharynx.
- Have a history of active tuberculosis, autoimmune disease, lung inflammation, infection, HIV, Hepatitis B, or Hepatitis C.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Louisville - James Graham Brown Cancer Center | 40202 | Louisville | Kentucky |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| University of Cincinnati Medical Center | 45219 | Cincinnati | Ohio |
| Ohio State University | 43210 | Columbus | Ohio |
| Medical University of South Carolina | 29425 | Charleston | South Carolina |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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