Diadem to Investigate the Activity and Safety of Durvalumab
- Sponsor
- Mario Negri Institute for Pharmacological Research
- Study ID
- NCT04115111
- Phase
- PHASE2
- Status
- Completed
Conditions
- Pleura Mesothelioma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Durvalumab — DRUGDurvalumab in monotherapy as second line treatment
Study Details
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.
Key Dates
- Start date
- Oct 17, 2018
- Status verified
- Mar 2023
- Primary completion
- May 16, 2019
- Completion
- May 16, 2019
Study Design
- Enrollment
- 57 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Durvalumab armPatients will receive Durvalumab at the dose and regimens described above every 4 weeks until evidence of disease progression or occurrence of unacceptable toxicity. Patients who show evidence of disease progression but appear to tolerate Durvalumab well, for whom no other treatment options exist and who, at the judgement of the investigator, may still enjoy clinical benefit, will be classified as failures and offered the possibility to continue treatment with extended follow up.
Primary Outcome Measure
Proportion of survived patients at 16 weeks [ Time Frame: 16 weeks ]