Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

Trisha Wise-Draper

Status and phase

Active, not recruiting

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: Pembrolizumab

Procedure: Surgery

Radiation: Radiation Therapy

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02641093

UCCI-HN-15-01

Details and patient eligibility

About

The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.

Enrollment

96 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients eligible for resection with one or more of the following
1. Any T stage with ≥ N2 disease;
2. T4 disease, any N stage;
3. T3 Oral Cavity, any N stage; or
4. Clinical evidence of extra-capsular extension on scans.
Must be willing to undergo definitive resection with neck dissection.
Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
Adequate labs
Appropriate staging imaging.

Exclusion criteria

Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment.
Nasopharyngeal or sinonasal carcinoma
Confirmed metastatic disease
Human Papillomavirus (HPV)+ disease of the oropharynx
Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C