drugset / Trial / NCT02592551
MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma
RandomizedParallel-groupOpen-labelOther
Summary
The objective of this study is to determine whether MEDI4736 or combination therapy with MEDI4736 + tremelimumab are associated with favorable alterations of the intratumoral immunologic environment in subjects undergoing resectional surgery for Malignant Pleural Mesothelioma MPM.
Timeline
- Start
- 2016-05-11
- Primary completion
- 2019-08-06
- Completion
- 2022-09-01
Outcome
Missed primary endpoint
registry analysis (other test); MEDI4736 + Tremelimumab; p = 0.109; Median Difference (Final Values) 8.6; Wilcoxon signed rank test NCT02592551 ↗
paper Both ICB regimens induced CD8 T-cell infiltration into MPM tumors but did not alter CD8/Treg ratios. PMID 36469573 ↗
Publications
- Mitra S, Jang HJ, Kuncheria A, Kang SW, Choi JM, Shim JS, Lee C, Ranchod P, Jindra P, Ramineni M, Patel M, Ripley RT, Groth SS, Blackmon SH, Burt BM, Lee HS. Soluble mesothelin-related peptide as a prognosticator in pleural mesothelioma patients receiving checkpoint immunotherapy. J Thorac Cardiovasc Surg. 2025 Apr;169(4):1082-1095.e4. doi: 10.1016/j.jtcvs.2024.10.005. Epub 2024 Oct 10.
- Lee HS, Jang HJ, Ramineni M, Wang DY, Ramos D, Choi JM, Splawn T, Espinoza M, Almarez M, Hosey L, Jo E, Hilsenbeck S, Amos CI, Ripley RT, Burt BM. A Phase II Window of Opportunity Study of Neoadjuvant PD-L1 versus PD-L1 plus CTLA-4 Blockade for Patients with Malignant Pleural Mesothelioma. Clin Cancer Res. 2023 Feb 1;29(3):548-559. doi: 10.1158/1078-0432.CCR-22-2566.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Comparator | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |