Description:
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.
Title
- Brief Title: Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
- Official Title: Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Clinical Trial IDs
- ORG STUDY ID:
UCCI-HN-15-01
- NCT ID:
NCT02641093
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Pembrolizumab | Keytruda | Pembrolizumab |
| Cisplatin | | Pembrolizumab |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Pembrolizumab | Experimental | Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation |
| Time Frame: | 30 days following completion of treatment |
| Safety Issue: | |
| Description: | Compare percentage of grade 3 and 4 adverse events with historical control percentages. |
Secondary Outcome Measures
| Measure: | Tumor immune response to pembrolizumab as measured by immunohistochemistry in tumor tissue before and after treatment |
| Time Frame: | 1 week |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Trisha Wise-Draper |
Last Updated
November 5, 2020
