DREAM3R: DuRvalumab (MEDI4736) With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma - A Phase 3 Randomised Trial
The purpose of this study is to investigate the effectiveness of durvalumab in combination with standard chemotherapy for mesothelioma. All participants in the study will receive standard first-line chemotherapy for mesothelioma. Two thirds of the participants in the study will be randomly assigned to also receive a new treatment called durvalumab. Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called Programmed death-ligand 1 (PD-L1). Blocking PD-L1 helps the body's immune system to attack cancer cells. Research has shown that durvalumab can slow tumour growth and shrink tumours in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma. This international study is being led jointly by the University of Sydney in Australia, and the Pr Eastern Cooperative Oncology Group (PrECOG) in the USA. The study plans to enrol 480 participants from hospitals throughout Australia, New Zealand and the USA.
NCT04181411 — Mesothelioma Malignant Advanced
Status: Not yet recruiting
http://inclinicaltrials.com/mesothelioma-malignant-advanced/NCT04181411/
Nivolumab With Chemotherapy in Pleural Mesothelioma After Surgery
Patients with malignant pleural mesothelioma stage I-III who have undergone cytoreductive surgery with curative intend consisting of extended pleurectomy / decortication (eP/D) with or without hyperthermic intrathoracic chemoperfusion (HITOC) who will receive a maximum treatment duration of 16 cycles (4 cycles of chemotherapy in both arms + 12 cycles maintenance immunotherapy in treatment arm B). The main objective of the trial is Time-to-next-treatment (TNT), as well as safety and tolerability.
NCT04177953 — Pleural Mesothelioma Malignant
Status: Active, not recruiting
http://inclinicaltrials.com/pleural-mesothelioma-malignant/NCT04177953/
Phase I Study of Cabozantinib in Combination With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC), Urothelial Cancer and Advanced Malignant Mesothelioma
This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no participants and their cancer.
NCT04173338 — Non Small Cell Lung Cancer
Status: Terminated
http://inclinicaltrials.com/non-small-cell-lung-cancer/NCT04173338/
Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma
This is a multi-centre non-randomised open-label phase 1 trial of pembrolizumab given in combination with SBRT to part of a pleural-based lesion in patients with unresectable MPM. This study will recruit up to 18 patients whose MPM has progressed beyond first-line of palliative chemotherapy, with a platinum-based doublet, and now requires further palliative systemic treatment, or have declined first-line palliative chemotherapy, however must have been considered suitable for a platinum doublet chemotherapy.
NCT04166734 — Advanced Malignant Pleural Mesothelioma
Status: Terminated
http://inclinicaltrials.com/advanced-malignant-pleural-mesothelioma/NCT04166734/
Feasibility and Safety of Neoadjuvant Nivolumab and Chemotherapy for Resectable Malignant Pleural Mesothelioma
This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.
NCT04162015 — Malignant Pleural Mesothelioma
Status: Active, not recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT04162015/
Identification of Biomarkers for the Early Detection of Mesothelioma
This is a two phase study, The first phase (phase 1) will identify potential biomarkers among asbestos exposed individuals with pleural mesothelioma. The second phase (phase 2), is a double blinded case-matched controlled study to determine the predictive capability, sensitivity, and specificity of these biomarkers in detecting early stage pleural mesothelioma. Biomarkers in the form of volatile organic compounds (VOC) in exhaled breath samples from subjects with either pleural mesothelioma or pleural plaques, will be evaluated. A biomarker present in serum will also be concurrently evaluated in the same cohort. The soluble serum biomarker mesothelin related peptides (SMRP), which has been posited as a biomarker for mesothelioma, will be analyzed for its relationship to the breath VOC profile.
NCT04106973 — Pleural Mesothelioma
Status: Terminated
http://inclinicaltrials.com/pleural-mesothelioma/NCT04106973/
A Single Dose FMT Infusion From a Healthy Family Donor Via Colonoscopy as an Adjunct to Keytruda for the Benefit of Improving Efficacy of Immunotherapy for Metastatic Mesothelioma
The investigators propose to ensure a favorable gut microbiome by fecal microbiota transplant to enhance the efficacy Keytruda
NCT04056026 — Mesothelioma
Status: Completed
http://inclinicaltrials.com/mesothelioma/NCT04056026/
Combining a WT1 Cancer Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Malignant Pleural Mesothelioma: A Phase I Study
The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.
NCT04040231 — Mesothelioma
Status: Active, not recruiting
http://inclinicaltrials.com/mesothelioma/NCT04040231/
A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection
This study aims to find the maximum tolerated dose level for malignant pleural mesothelioma patients receiving background radiation + boost radiation, and surgery. Boost radiation is an experimental form of radiation that involves targeting non-uniform high doses of radiation to bulky pleural masses. We hypothesize the immunologic abscopal effect is an important component in controlling disease, and may be stimulated with highly hypofractionated doses. Doses will increase with every three patients who will be enrolled in the study until the background radiation reaches 1800 cGy or the maximum tolerated dose, whichever is lower.
NCT04028570 — Mesothelioma; Lung
Status: Active, not recruiting
http://inclinicaltrials.com/mesothelioma-lung/NCT04028570/
A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma
Twelve patients with relapsed malignant pleural mesothelioma will be treated with intratumoral injections of MTG201, a replication incompetent adenovirus, modified by the insertion of the reduced expression in immortalized cells (REIC)/Dikkopf (Dkk)-3 gene, on Days 1, 8, 22, and 50. Patients will also receive every 4 weekly intravenous infusions of nivolumab, 480 mg, starting on Day 2. Safety and anti-tumor activity will be monitored at regular intervals throughout the study.
NCT04013334 — Malignant Pleural Mesothelioma
Status: Active, not recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT04013334/