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Brief Title: Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma
Official Title: Open Label, Phase II Study of Anti - Programmed Death - Ligand 1 Antibody, Durvalumab (MEDI4736), in Combination With Chemotherapy for the First-Line Treatment of Unresectable Mesothelioma
Study ID: NCT02899195
Brief Summary: 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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University San Diego Moores Cancer Center, La Jolla, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
Stanford Cancer Institute, Stanford, California, United States
University of Colorado, Anschutz Cancer Pavilion, Aurora, Colorado, United States
University of Miami Hospital, Miami, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
NorthShore University HealthSystem, Evanston, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Washington University in St Louis, Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New York University Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Hillman Cancer Center Research Pavilion, Pittsburgh, Pennsylvania, United States
UTSW Medical Center, Dallas, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
University of Washington Seattle Cancer Care Alliance, Seattle, Washington, United States
Aurora Cancer Center, Wauwatosa, Wisconsin, United States
Name: Patrick Forde, MD
Affiliation: John Hopkins
Role: STUDY_CHAIR