A Phase III Study of Immunotherapy versus Chemotherapy to Treat Inoperable Pleural Mesothelioma

Full Title

CA209743: A Phase III, Randomized, Open Label Trial of Nivolumab in Combination with Ipilimumab versus Pemetrexed with Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma


Pleural mesothelioma is a cancer of the lining of the lungs that is typically caused by asbestos exposure. It can be challenging to treat. In this study, researchers are assessing the effectiveness of immunotherapy with the drugs nivolumab and ipilimumab as the first treatment for patients with advanced inoperable pleural mesothelioma.

Patients in this study will be randomly assigned to one of two groups. One group will receive nivolumab and ipilimumab. The other group will receive pemetrexed with either cisplatin or carboplatin. All of these drugs are given intravenously (by vein).

Nivolumab boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells. It is approved for treating several types of cancer.

Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down at the right time. Ipilimumab is already approved for treating melanoma, alone and in combination with nivolumab. The use of nivolumab and ipilimumab together for treating pleural mesothelioma is considered investigational.


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced inoperable pleural mesothelioma that has not yet been treated with chemotherapy.
  • Prior radiation therapy to relieve symptoms is permitted, as long as 2 weeks pass after the last treatment and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Marjorie Zauderer at 646-888-4656.