A082101 Sarcomatoid Mesothelioma Stage 1-3

What is the Purpose of this Study?

We are doing this study to compare the usual treatment of Nivolumab and ipilimumab to using the usual treatment plus surgery for people with sarcomatoid mesothelioma. We want to find out if adding surgery to the immunotherapy regimen is effective in stabilizing this type of cancer.

What is the Condition Being Studied?

Sarcomatoid Mesothelioma

Who Can Participate in the Study?

Adults ages 18+ who are diagnosed with sarcomatoid mesothelioma.

For more information about who can join this study, please contact the study team at jennifer.j.brown@duke.edu

Age Group
Adults

What is Involved?

If you choose to join this study, you will go through a screening period that lasts up to 4 weeks to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have blood draws
- Have a tumor biopsy
- Have imaging (CT or PET scan, or MRI)
- Give urine samples

If you are eligible, you will begin the study regimen and get a dose of nivolumab every 3 weeks and a dose of ipilimumab every 6 weeks. Both drugs are given as an intravenous (IV) infusion into a vein.

After receiving the study drugs for 12 weeks, you will be assessed for surgery. If you are able to have surgery, it will be within 90 days after your last dose of the study drugs. If you are not eligible for surgery, we will monitor your progress and your doctor will treat you as they see fit.

Study Details

Full Title
A082101: Multimodality Therapy with Immunotherapy in Stage I-IIIA Sarcomatoid Mesothelioma
Principal Investigator
Associate Professor of Medicine
Protocol Number
IRB: PRO00113814
NCT: NCT05647265
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL