BaylorESR-21-21550 (Malignant Pleural Mesothelioma)

Purpose of this Study

We are doing this study to find out whether certain immunotherapy drug combinations with and without chemotherapy given before and after surgery for mesothelioma can help prevent the tumor from coming back. The two immunotherapy drugs, durvalumab and tremelimumab, are called immune checkpoint inhibitors and are used to activate the immune system against cancer. Immune checkpoint inhibitors are now approved for mesothelioma for patients who cannot undergo surgery, but they are not approved prior to surgery. The chemotherapy drugs (cisplatin or carboplatin and pemetrexed) are standard options for the treatment of mesothelioma.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with MPM and are being considered for surgical removal of this tumor
  • Have never been treated with a PD1 or PD-L1 inhibitor, including durvalumab
For more information, contact the study team at annemarie.peters@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
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
  • Group A: If you are in this group, you will only receive the two immunotherapy drugs.
  • Group B: If you are in this group, you will receive the two immunotherapy drugs plus the two standard chemotherapy drugs.
The two immunotherapy study drugs are given by injection into a vein (intravenous) three times prior to surgery, 3 weeks apart. Following recovery from surgery, the immunotherapy drugs will continue, but not the chemotherapy, for a maximum of 12 months. During this period, both durvalumab and tremelimumab are given for 5 cycles or 5 months. Then, durvalumab alone is given for the remainder of the 12 months (7 cycles). No chemotherapy will be administered after surgery regardless of whether it was received prior to surgery.

Locations

Duke University Hospital

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

Combination of Induction Durvalumab and Tremelimumab alone versus Durvalumab and Tremelimumab with chemotherapy for Potentially Resectable Pleural Mesothelioma. ESR-21-21550

Principal Investigator

Jeffrey
Clarke

Protocol Number

PRO00113797

NCT ID

NCT05932199

Phase

I/II

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov