A082101 Sarcomatoid Mesothelioma Stage 1-3

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)

Female (cisgender)

Non-binary or gender fluid

Transgender male

Transgender female

Looking for Healthy Participants

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Spanish Materials Available

Yes

Study Details

Full Title

Multimodality Therapy with Immunotherapy in Stage I-IIIA Sarcomatoid Mesothelioma

Principal Investigator

Jeffrey

Clarke

Protocol Number

PRO00113814

NCT ID

NCT05647265

Phase

N/A

Enrollment Status

Open to Enrollment

ClinicalTrials.gov