Study on Immune Checkpoint Blockade Before Surgery for Treatable Malignant Pleural Mesothelioma

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT03918252

Provider View

This clinical trial is testing the safety and feasibility of using immune checkpoint inhibitors, nivolumab and possibly ipilimumab, before surgery in patients with treatable malignant pleural mesothelioma (MPM). After surgery, patients will continue to receive nivolumab for one year as part of their treatment.

Patient Parameters

Program Overview

The study aims to evaluate if using the immune therapy drug nivolumab, with or without ipilimumab, before surgery is safe and feasible for patients with treatable malignant pleural mesothelioma (MPM). After completing standard treatment, patients will continue to receive nivolumab for one year to help manage their condition.

Description

In this study, patients with treatable malignant pleural mesothelioma (MPM) will receive the immune therapy drug nivolumab before surgery. In one group, 15 patients will receive nivolumab alone, while another group of 15 patients will receive both nivolumab and ipilimumab before surgery. The treatment schedule involves receiving these medications at specific intervals leading up to the planned surgery date. After surgery, patients will continue to receive nivolumab for one year as part of their ongoing treatment plan. The study aims to determine if this approach is safe and feasible for patients with MPM.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 years or older.
  • Must have a primary tumor that can be safely biopsied for research purposes.
  • Must have a confirmed diagnosis of epithelial or biphasic malignant pleural mesothelioma (MPM).
  • Tumor samples must be available for biomarker evaluation.
  • Cancer must be at Stage I-III and considered potentially removable by surgery.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still perform light work.
  • Must have adequate organ function, including specific blood cell counts and kidney and liver function.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for a specified period after the last dose of nivolumab.
  • Must understand the study requirements and be willing to sign an informed consent form.

Exclusion Criteria

  • Cancer is not removable by surgery or the patient is not a good candidate for surgery or study therapy.
  • Have a type of mesothelioma called pure sarcomatoid.
  • Have an active autoimmune disease, except for certain conditions like vitiligo or type I diabetes.
  • Require systemic treatment with corticosteroids or other immunosuppressive medications.
  • Have received chemotherapy or other cancer therapy before surgery.
  • Have another active cancer, except for certain non-threatening types.
  • Have a history of lung disease or active infections requiring treatment.
  • Test positive for hepatitis B, hepatitis C, or HIV.
  • Have a known allergy to the study drugs.
  • Are pregnant or breastfeeding.
  • Have previously received certain immune therapies.
  • Have any condition that may require immunosuppressant medications during the study.
  • Have other medical conditions that could make the study treatment unsafe or affect the study results.
  • Are prisoners or involuntarily detained individuals.

Locations

FACILITYZIPCITYSTATE
Greenebaum Comprehensive Cancer Center University of Maryland School of Medicine21201BaltimoreMaryland
Johns Hopkins University21287BaltimoreMaryland
University of Texas M.D. Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.