Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of concurrent administration of influenza vaccine in patients receiving anti-PD1 immunotherapy (nivolumab or pembrolizumab). This will be a prospective observational study, aiming to assess patient tolerance of treatment, adverse events (incidence, grade, need for hospitalization), incidence of influenza infections, and seroconversion rates.

Official Title
-----------------
Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)

Conditions
-----------------
Influenza Virus Vaccine Adverse Reaction (Disorder), Influenza, Malignancy

Intervention / Treatment
-----------------
* Biological: influenza vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Currently receiving immunotherapy with anti-PD-1 agents (Nivolumab or Pembrolizumab) Have not received influenza vaccination prior to study entry date for the upcoming flu season 2016-2017 No previous contraindication to receiving influenza vaccination Histologically proven cancer Expected lifetime of at least 12 weeks Exclusion Criteria: Previous cancer Autoimmune disease or immunosuppressive treatments Corticosteroid treatment Those who have a potential indication to change chemotherapy treatment in 42 days following start of treatment History of clinically or virologically confirmed influenza infection in the previous six months Previous contraindication to receiving influenza vaccination Previous allergic/adverse reaction with influenza vaccination Have received influenza vaccination prior to study entry date for upcoming 2016-2017 flu season Positive anti influenza antibody titers as determined by the baseline blood determination (day 0)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: influenza vaccination|administration of influenza vaccination|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with confirmed influenza infection as assessed by influenza rapid antigen A and B testing, nose swab. |  | October 1st 2016 to March 31st 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events and grading of adverse event as measured by the adverse events toxicity scale. |  | October 1st 2016 to March 31st 2017 | 
| Number of participants requiring hospitalizations for adverse events or influenza infection. |  | October 1st 2016 to March 31st 2017 | 
| Number of participants with seroconversion as assessed by influenza A and B IgM and IgG titers. |  | October 1st 2016 to March 31st 2017 |