Clinical trial NCT02641093: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-12-29
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Effects
timeFrame: All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution.
measure: Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
timeFrame: 1 year
measure: Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
timeFrame: 1 year
Secondary outcomes:
measure: Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue
timeFrame: 1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken
measure: Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
timeFrame: 1 year
measure: Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
timeFrame: 1 year
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville - James Graham Brown Cancer Center
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of Cincinnati
name: Trisha Wise-Draper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: