Mesothelioma

CheckpOiNt Blockade For Inhibition of Relapsed Mesothelioma (CONFIRM)

July 12, 2017
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Purpose:The UK has the highest incidence of mesothelioma. The incidence has risen by 497% since the late 1970’s and is increasing worldwide due to continued mining and use of asbestos. For patients with mesothelioma who have relapsed after taking pemetrexed and cisplatin, there is currently no standard treatment, making this an urgent unmet need. Recent trials in this area have not found an effective treatment that improves overall survival.

Following a debate in the House of Lords, a national survey assessing the research priorities in mesothelioma found that ‘exploiting the potential of immunotherapy’ was a top priority. This trial was designed in response to that survey. It uses the immunotherapy agent nivolumab which blocks programmed cell death 1 (PD-1) receptor on activated T-cells (a type of white blood cell forming part of the immune system). Early research has found a dependency of mesothelioma on the PD-1 checkpoint. By attaching to PD-1, nivolumab blocks its action (checkpoint inhibition), preventing it from turning off the T-cell, and therefore allowing the immune system to work. PD-1 checkpoint inhibition has revolutionised the treatment of melanoma and it is hoped to be as effective in mesothelioma.

This trial is a randomised, double blind placebo controlled trial of patients with mesothelioma who are third relapse following a platinum based chemotherapy treatment. Patients will be randomised in a 2:1 ratio (nivolumab: placebo).

336 patients will be recruited from 25 UK centres over a four-year period with the last patient having a minimum of 6 months follow up. All patients will be on treatment for 12 months unless they progress or withdrawal prior to this. Clinic visits will occur every 12 weeks, mirroring standard care. Data following progression will be obtained from the NHS Information Centre.

Adjuvant Pembrolizumab After Radiation Therapy for Lung-Intact Malignant Pleural Mesothelioma

June 28, 2017
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Purpose: The goal of this clinical research study is to assess the safety of pembrolizumab (also called MK-3475) after radiation therapy (with or without surgery and/or chemotherapy) in patients with MPM.

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

June 14, 2017
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Purpose: This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and to see how well it works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.

CAR T Cells in Mesothelin Expressing Cancers

May 17, 2017
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Purpose: Phase I study to establish safety and feasibility of intravenous or intrapleural administered lentiviral transduced huCART-meso cells with or without lymphodepletion. Intravenous administration of huCART-meso cells is planned with or without cyclophosphamide as lymphodepleting chemotherapy.

Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma

May 3, 2017
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Purpose: This randomized phase I/II trial studies the side effects and how well pembrolizumab with or without anetumab ravtansine work in treating patients with mesothelin-positive pleural mesothelioma. Monoclonal antibodies, such as anetumab ravtansine and pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

April 26, 2017
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Purpose: The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma (PrE0505)

April 19, 2017
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Purpose: 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).

A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma

April 5, 2017
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Purpose: his research study is studying a pair of immunotherapies as a possible treatment for malignant pleural mesothelioma. The drugs involved in this study are Durvalumab and Tremelimumab.

Safety Study of MGD009 in B7-H3-expressing Tumors

March 29, 2017
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Purpose: The purpose of this study is to evaluate the safety of MGD009 when given to patients with B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that can be given safely. Assessments will be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity of MGD009.

A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

March 22, 2017
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Purpose The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with nivolumab in participants with locally advanced or metastatic solid tumors. The study will consist of 2 parts: ABBV-368 dose escalation and ABBV-368 tumor-specific dose expansion (non-small cell lung cancer [NSCLC] cohort and head and neck cancer cohort) .