Diadem to Investigate the Activity and Safety of Durvalumab (NCT04115111) | Clinical Trial Compass
CompletedPhase 2
Diadem to Investigate the Activity and Safety of Durvalumab
Italy57 participantsStarted 2018-10-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histological diagnosis of advanced unresectable MPM;
✓. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 5 unstained slides for central determination of PD-L1 expression;
✓. Aged ≥ 18 years;
✓. Performance status 0-1 (ECOG);
✓. Measurable disease as defined by Modified RECIST v1.1 for MPM;
✓. One previous chemotherapy line for MPM, based on pemetrexed plus platinum derivative combination;
✓. Previous chemotherapy course concluded at least 4 weeks prior to recruitment;
✓. Signed informed consent;
Exclusion criteria
✕. Radiotherapy with curative intent to thoracic wall (concomitant with or prior to chemotherapy);
✕. Severe concomitant illness;
What they're measuring
1
Proportion of survived patients at 16 weeks
Timeframe: 16 weeks
Trial details
NCT IDNCT04115111
SponsorMario Negri Institute for Pharmacological Research