Last updated on July 2018

Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma

Brief description of study

Patients with pleural mesothelioma that can not be surgically removed will receive durvalumab, in combination with standard chemotherapy of pemetrexed and cisplatin as first-line treatment.

Durvalumab is a type of drug called a monoclonal antibody (a type of protein). Laboratory tests show that it works by allowing the immune system to detect your cancer and reactivates the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die.

The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS).

Detailed Study Description

Mesothelioma is a malignant tumor of the mesothelial surfaces primarily arising in the thoracic pleura and is estimated to cause 43,000 deaths worldwide each year with over 3300 cases occurring annually in the United States. Approximately 80% of cases of mesothelioma are due to inflammation induced by prior asbestos exposure with a lead time from exposure to development of cancer of 20-30 years.

This is a single arm, open label phase II study of the anti-PD-L1 antibody, durvalumab, in combination with standard chemotherapy. Pemetrexed and cisplatin will be given for up to six 3-week cycles with the addition of concurrent durvalumab dosed every 3 weeks. The first 6 patients who are enrolled and commence treatment will be monitored for safety of the combination. Use of carboplatin in place of cisplatin will be permitted for patients who are ineligible for cisplatin due to impaired renal function at screening, however these patients must otherwise fulfill the eligibility criteria for the study. For patients that receive cisplatin, carboplatin may also be substituted after Cycle 1 for cisplatin related toxicity (e.g., grade 3 ototoxicity, grade 3 nausea) at the investigator's discretion. After completion of Cycle 6 of concurrent therapy, patients with stable or responding disease per modified RECIST for malignant mesothelioma will continue on single agent durvalumab every 3 weeks until progression. Maximum duration of durvalumab treatment is 12 months starting from Cycle 1 of concurrent treatment (inclusive of any treatment delays or missed treatments).

Tumor assessments will be performed approximately every 6 weeks during concurrent therapy and every 9 weeks during the maintenance phase.

Mandatory pre-treatment tumor tissue sample (i.e., obtained during a previous procedure or biopsy) and blood samples (prior to Cycle 1, Cycle 2 and Cycle 5) for research will also be required.

Clinical Study Identifier: NCT02899195

Contact Investigators or Research Sites near you

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Joel W. Neal, MD, PhD

Stanford Cancer Institute
Stanford, CA United States

Tom Purcell, MD

University of Colorado, Anschutz Cancer Pavilion
Aurora, CO United States

Chukwuemeka Ikpeazu, MD

University of Miami Hospital
Miami, FL United States

Hedy Kindler, MD

University of Chicago Medical Center
Chicago, IL United States

Patrick Forde, MD

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, MD United States

Philip Stella, MD

St. Joseph Mercy Hospital
Ann Arbor, MI United States

Arkadiusz Dudek, MD

Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, MN United States

Joseph Aisner, MD

Rutgers Cancer Institute of New Jersey
New Brunswick, NJ United States

Leena Gandhi, MD

New York University Laura and Isaac Perlmutter Cancer Center
New York, NY United States

Hossein Borghaei, DO, MS

Fox Chase Cancer Center
Philadelphia, PA United States

Timothy Burns, MD, PhD

Hillman Cancer Center Research Pavilion
Pittsburgh, PA United States

Jonathan Dowell, MD

UTSW Medical Center
Dallas, TX United States

Bernardo Goulart, MD

University of Washington Seattle Cancer Care Alliance
Seattle, WA United States

Hatim Husain, MD

University San Diego Moores Cancer Center
La Jolla, CA United States

Conor Steuer, MD

Winship Cancer Institute of Emory University
Atlanta, GA United States

Alexander Spira, MD

Virginia Cancer Specialists
Fairfax, VA United States

Michael Thompson, MD, PhD

Aurora Cancer Center
Wauwatosa, WI United States

Aaron Lisberg, MD

Ronald Reagan UCLA Medical Center
Los Angeles, CA United States

Nicholas Campbell, MD

NorthShore University HealthSystem
Evanston, IL United States

Jeffrey Ward, MD

Washington University in St Louis
Saint Louis, MO United States

Recruitment Status: Closed

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