Purpose of this Study
We are doing this study to compare different treatment options for people who have surgery to remove melanoma. We want to know if it is better to treat people with nivolumab alone after surgery, or if it is better to give people a combination of nivolumab and ipilimumab.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with stage III resectable melanoma
- Do not have uveal or mucosal melanoma
For more information about who can join this study, please contact the study team at kayotta.johnson@duke.edu.
- Are diagnosed with stage III resectable melanoma
- Do not have uveal or mucosal melanoma
For more information about who can join this study, please contact the study team at kayotta.johnson@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
The study is divided into 2 periods: a screening period and a study dosing period.
If you choose to join the study, you will go through a screening period to see if you are eligible. During this period, you will:
- Have a physical exam
- Answer questionnaires
- Have blood draws
- Have imaging scans (X-Ray, MRI, CT, or PET)
- Have a tumor biopsy
If you are eligible to proceed to the study dosing period, you will:
- Take a fixed dose of 480 mg nivolumab
- Have surgery to remove your tumor about 4 weeks later
After surgery, we will test what kind of cells you have left where the tumor was removed. If less than 10% of the cells are viable tumor cells, this will be considered a complete or near complete response. You will not have any further treatment.
If you do not have a complete or near complete response, you will:
- Be randomly assigned (like a coin flip) to 1 of 2 different treatment arms
-- One treatment arm will get a dose of nivolumab every 4 weeks
-- The other treatment arm will get nivolumab and ipilimumab every 3 weeks
If you choose to join the study, you will go through a screening period to see if you are eligible. During this period, you will:
- Have a physical exam
- Answer questionnaires
- Have blood draws
- Have imaging scans (X-Ray, MRI, CT, or PET)
- Have a tumor biopsy
If you are eligible to proceed to the study dosing period, you will:
- Take a fixed dose of 480 mg nivolumab
- Have surgery to remove your tumor about 4 weeks later
After surgery, we will test what kind of cells you have left where the tumor was removed. If less than 10% of the cells are viable tumor cells, this will be considered a complete or near complete response. You will not have any further treatment.
If you do not have a complete or near complete response, you will:
- Be randomly assigned (like a coin flip) to 1 of 2 different treatment arms
-- One treatment arm will get a dose of nivolumab every 4 weeks
-- The other treatment arm will get nivolumab and ipilimumab every 3 weeks
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Adjuvant Nivolumab or Ipilimumab + Nivolumab Determined by Pathological Response to a Single Dose of Neoadjuvant Nivolumab
Principal Investigator
April
Salama
Protocol Number
PRO00108914
NCT ID
NCT04013854
Phase
II
Enrollment Status
OPEN TO ACCRUAL