Diadem to Investigate the Activity and Safety of Durvalumab

Summary

Malignant pleural mesothelioma (MPM) is a cancer with high mortality rate and few therapeutic options.essentially all patients usually progress and die subsequently to a first line therapyl. There is strong evidence that the immune system is deeply involved in the biogenesis of MPM and that an imbalance in pro-inflammatory cytokines and exhausted adaptive T-cell mediated immune response are the main causes of neoangiogenesis, progression and metastatisation processes.Numerous Phase II-III clinical trials are underway evaluating Durvalumab either as monotherapy or combination with evidence of activity in a wide range of solid tumors. Durvalumab has received FDA approval as second line treatment in patients with locally advanced or metastatic urothelial carcinoma. Given these prospects for PD-L1 Ab, a Phase II study is proposed in order to evaluate the activity and safety of Durvalumab in advanced pretreated MPM.

Timeline

Start

2018-10-17

Primary completion

2019-05-16

Completion

2019-05-16

Publications

• Results Canova S, Ceresoli GL, Grosso F, Zucali PA, Gelsomino F, Pasello G, Mencoboni M, Rulli E, Galli F, De Simone I, Carlucci L, De Angelis A, Belletti M, Bonomi M, D'Aveni A, Perrino M, Bono F, Cortinovis DL; DIADEM groupD. Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma. ESMO Open. 2022 Dec;7(6):100644. doi: 10.1016/j.esmoop.2022.100644. Epub 2022 Dec 1.

Drugs

Indications