NCT05041062

A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma

A Phase II Prospective, Open-label Trial of Perioperative Combination Nivolumab and Ipilimumab in Patients With Resectable Malignant Peritoneal Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for individuals who have peritoneal mesothelioma, a cancer of the lining of your abdominal wall and organs (the peritoneum). Doctors leading the study would like to determine the effects of treating this cancer with immunotherapy drugs (nivolumab and ipilimumab - the two study drugs that will be used in this study) before and after surgery. Doctors hope to learn if giving these two drugs before surgery will decrease the amount of viable (live) cancer cells that remain at the time of surgery and whether it will delay the time it could take for the cancer to regrow.

Conditions

• Mesothelioma
• Peritoneal Mesothelioma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab is an immunotherapy drug (a type of drug that helps your immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion.
DRUG	Ipilimumab	Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps your own immune system attack cancer cells.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-04-13
• Completion: 2023-04-13
• First posted: 2021-09-10
• Last updated: 2024-01-03
• Results posted: 2024-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study