Neoadjuvant Immunotherapy in Brain Metastases - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if we can boost the immune system to kill brain cancer cells if we give the immunotherapy agents, Nivolumab and Ipilimumab, before surgery.

What is the Condition Being Studied?

Brain Metastases

Who Can Participate in the Study?

Adults, 18+ who:
-Have 1 to 3 untreated brain metastases that are less than 4cm in size
-Planned for surgical resection and stereotactic radiosurgery (SRS)
-Are taking 4mg or less of daily dexamethasone
-Have not had immunotherapy in the past 3 months
-Are not pregnant

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Be randomized (like the flip of a coin) into 1 of 2 groups:
--Group 1 will be given the immunotherapy agents, Nivolumab and Ipilimumab
--Group 2 will not be given the immunotherapy agents, nivolumab and ipilimumab
-Have an Magnetic Resonance Imaging (MRI) scan before your surgery
-Have tests such as a physical exam and blood tests each time you come to Duke
-Have surgery and stereotactic radiosurgery (SRS)

For more information about who can be in this study, please contact the study team.

Study Details

Full Title
A randomized Phase II trial of surgery and stereotactic radiosurgery with and without neoadjuvant nivolumab and ipilimumab in patients with surgically-resectable, solid tumor brain metastases
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00103812
NCT: NCT04434560
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698