Phase II Trial of Olaparib in Homologous Recombination Deficient (HRD) Malignant Mesothelioma
In this study, researchers will give olaparib (a drug) to mesothelioma patients who have specific changes in their DNA (known as gene mutations). Researchers will give this drug to each patient on the study to find out if it will help the patient's tumor shrink or stop growing.
NCT04515836 — Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/mesothelioma/NCT04515836/
A Three-Cohort Phase II Trial to Assess the Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Pleural or Malignant Peritoneal MESOthelioma Patients
Malignant mesothelioma is an invasive neoplasm that arises from mesothelium that lines several organs. Common primary sites of origin of mesotheliomas are the pleura (malignant pleural mesothelioma: 85%) and peritoneum (malignant peritoneal mesothelioma 15%), and rarely the pericardium and tunica vaginalis. The standard of care recommended for malignant pleural mesotheliomas (MPM) is palliative chemotherapy based on a doublet of platinum salt and an anti-folate. The median survival of patients with pleural MPM is around 8 months with best supportive care only, 12 to 19 months when systemic chemotherapy is used with or without anti-angiogenic agents or targeted therapy. There is an unmet need for innovative approaches in pleural mesotheliomas. Malignant peritoneal mesothelioma is an aggressive neoplasm that arises from the lining mesothelial cells of the peritoneum and spreads extensively within the confines of the abdominal cavity. Cytoreductive surgery (CRS) followed by hyperthermic intraoperative peritoneal perfusion with chemotherapy (HIPEC) is the standard curative approach when it is possible, with respect to peritoneal carcinomatosis extend. When the cytoreductive surgery is impossible, the common strategy is to prescribe systemic chemotherapy, with the objective of downsizing tumor lesions for potential subsequent CRS. The standard strategy based on cisplatin - pemetrexed combination regimen has been extrapolated from pleural mesothelioma management principles. Genomic landscape of mesotheliomas is now well described. Pleural and peritoneal malignant mesotheliomas harbor closed genomic instability. Strategies based on maintenance-based treatments with Poly (ADP-ribose) polymerase (PARP) inhibitors, especially olaparib, niraparib and talazoparib, have been shown effective in ovarian cancer patients, thereby leading to their approvals. The benefit has been mainly observed in patients with homologous recombination deficiencies (HRD), but also in all-comers patients in a lesser extent. It is thought that HRD induces addiction of cancer cells to PARP, thereby leading to cell death in the presence of PARP inhibitors. As a consequence, given the prevalence of HRD, through BAP-1 mainly, in mesotheliomas, maintenance treatment with PARP-inhibitor in malignant mesothelioma patients without any progressive disease after 4 to 6 cycles of platinum-based chemotherapy may be associated with increased progression free survival, as it was shown in ovarian cancer patients. TALAMESO aims to evaluate the efficacy of talazoparib maintenance treatment given for maximum 2 years following 4 to 6 cycles of platinum-based first line chemotherapy in terms of proportion of patients progression free 6 months after starting the maintenance, and progression-free survival, in patients with advanced malignant pleural (cohort A) or peritoneal (cohorts B1 and B2) mesotheliomas. Cohorts B1 and B2 are meant to confirm that talazoparib can increase progression free survival in both patient populations with non-resected or incompletely resected disease (cohort B1) or with completely resected disease (cohort B2). TALAMESO is an open-label phase II trial with 3 independent cohorts (Fleming's single-stage) including patients with advanced malignant pleural (cohort A) or peritoneal (cohort B1 and B2) mesotheliomas without any sign of disease progression after 4 to 6 cycles of platinum-based chemotherapy (including minimum 1 cycle of pemetrexed).
NCT04462809 — Advanced Malignant Pleural or Peritoneal Mesothelioma
Status: Not yet recruiting
http://inclinicaltrials.com/advanced-malignant-pleural-or-peritoneal-mesothelioma/NCT04462809/
Evaluation of Cryo-Immune Stimulation in Mesothelioma
This trial evaluates if cryoablation will stimulate a local immune response by cluster of differentiation 8 positive (CD8+) cells which are not present in ablation naive regions of the tumors in patients with mesothelioma. Cryoablation uses extreme cold to damage or destroy tumor lesions. Mesothelioma is a rare cancer that grows and spreads quickly, and has low survival rates. The information learned from this study may provide evidence as to whether there is a measurable, local immune response from cryoablation. Studying samples of mesothelioma tissue in the laboratory from patients who have undergone biopsy may help doctors learn more about the effects of cryoablation on cells. It may also help doctors understand how well patients respond to treatment.
NCT04429204 — Mesothelioma
Status: Withdrawn
http://inclinicaltrials.com/mesothelioma/NCT04429204/
Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma
The purpose of this study is to offer a novel cancer vaccine called poly-ICLC (Hiltonol®) for subjects with malignant pleural mesothelioma by directly injecting the vaccine into the tumor. This trial will enroll a maximum of 18 patients with biopsy proven malignant pleural mesothelioma who are surgically resectable. Subjects will undergo core biopsies of their mesothelioma followed by direct injection of Poly ICLC, a TLR3 agonist which has been shown to have biological and immunological effects. Within two to three weeks following the injection, the patients will undergo a pleurectomy/decortication or EPP, as is standard of care. Tissue resected at that time will be compared to tissue obtained at biopsy prior to the injection of the immunological agent.
NCT04345705 — Mesothelioma
Status: Not yet recruiting
http://inclinicaltrials.com/mesothelioma/NCT04345705/
DREAM3R: DuRvalumab (MEDI4736) With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma - A Phase 3 Randomised Trial
Patients with pleural mesothelioma (PM) that cannot be surgically removed will receive standard chemotherapy (cisplatin or carboplatin and pemetrexed) given with durvalumab, a type of immunotherapy, or a treatment chosen by the study doctor, which is either standard chemotherapy or immunotherapy combination (ipilimumab and nivolumab). 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 attack cancer cells. Research has shown that durvalumab can slow tumor growth and shrink tumors in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma. The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS) in patients with PM.
NCT04334759 — Mesothelioma
Status: Active, not recruiting
http://inclinicaltrials.com/mesothelioma/NCT04334759/
Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (the NIPU-study)
The objective of the study is to induce a meaningful progression-free survival benefit in patients with Malign Pleural Mesothelioma (MPM) after progression on first line standard platinum doublet chemotherapy, by treating with nivolumab and ipilimumab with or without UV1 vaccine.
NCT04300244 — Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/cancer/NCT04300244/
A Phase II, Single Arm, Multicenter and Open Labelstudy Evaluating the Efficacy, Safety and Pharmacokinetics of HMPL-453 in Patient With Advanced Malignant Mesothelioma
This is a phase II, single arm, multicenter and open-label study to evaluate the efficacy, safety and pharmacokinetic of HMPL-453 in patient with advanced Malignant Mesothelioma
NCT04290325 — Advanced Malignant Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/advanced-malignant-mesothelioma/NCT04290325/
PEMbrolizumab Plus Lenvatinib In Second Line And Third Line Malignant Pleural MEsotheLiomA Patients(PEMMELA)
There is no standard second line treatment in malignant pleural mesothelioma (MPM). Pembrolizumab has shown to be active in in small phase II studies in MPM. Its activity however, is limited, with a response rate up to 20%. Since the arrival of nivolumab plus ipilimumab as first line standard of care treatment in mesothelioma, no treatment options are investigated in this group of patients in the second line. So, there is a need for new treatment combinations with drugs that might exhibit a synergistic interaction with pembrolizumab.
NCT04287829 — Mesotheliomas Pleural
Status: Recruiting
http://inclinicaltrials.com/mesotheliomas-pleural/NCT04287829/
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
NCT04214015 — Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/mesothelioma/NCT04214015/
Phase IA-IB Open-label, Non-randomized, Neoadjuvant Treatment With Combination Pembrolizumab and Defactinib for Patients With Surgically Resectable Malignant Pleural Mesothelioma
This research study is studying a new drug combination of Pembrolizumab and Defactinib followed by surgical resection possible treatment for resectable Malignant Pleural Mesothelioma (MPM). The names of the study drugs involved in this study are: - Pembrolizumab - Defactinib
NCT04201145 — Malignant Pleural Mesothelioma
Status: Withdrawn
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT04201145/