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Mesothelioma, Malignant clinical trials

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NCT ID: NCT05451849 Active, not recruiting - Colorectal Cancer Clinical Trials

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

Start date: June 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.

NCT ID: NCT05449366 Recruiting - Clinical trials for Peritoneal Malignant Mesothelioma

Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma

INTERACT MESO
Start date: February 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Patients primary malignant peritoneal mesothelioma (MPM), without extra-abdominal disease, that are not eligible (or willing) to undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) can be included in this study. Patients will be treated with intraperitoneal (IP) chemotherapy (paclitaxel) in weekly cycles. The primary aim of this study is to determine the maximum tolerable dose (MTD) of IP monotherapy with paclitaxel for patients with MPM. The secondary aims are to assess safety and feasibility of this strategy, and to study the pharmacokinetics of paclitaxel in this setting.

NCT ID: NCT05429866 Recruiting - Breast Cancer Clinical Trials

Immunological Variables Associated to ICI Toxicity in Cancer Patients

Start date: September 1, 2022
Phase: Phase 2
Study type: Interventional

This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy. For enrolled subjects, clinical and laboratory evaluations will be performed and reported at different time points: - Early (4-6 weeks after treatment start) - Midtime (8-11 weeks after treatment start) - Late (13-18 weeks after treatment start) - At the occurrence of immune-related adverse events (irAEs), clinical and laboratory evaluation will be performed at two principal time points: - For the 1st time of any grade 1 or 2 irAE if the subject developed it. - For the 1st time of any grade 3 or 4 irAE if the subject developed it.

NCT ID: NCT05425576 Not yet recruiting - Clinical trials for Malignant Pleural Mesothelioma

OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition

Start date: June 2025
Phase: Phase 2
Study type: Interventional

This is a study of OT-101, a TGF-b2 inhibitor in combination of pembrolizumab in patients with malignant pleural mesothelioma. Both efficacy assessment, and safety and tolerability of various dose of OT-101 in combination of pembrolizumab are evaluated.

NCT ID: NCT05380713 Recruiting - Clinical trials for Mesothelioma, Malignant

......SMARTEST Trial......

Start date: May 3, 2022
Phase: Phase 2
Study type: Interventional

The SMARTEST trial is a phase II non-blinded randomized trial designed to evaluate the benefit of low dose cyclophosphamide in sequential combination with sub-ablative radiation (Arm A) versus sub-ablative radiation alone (Arm B) before surgery as well as the safety and efficacy of consolidation tremelimumab-durvalumab for eligible patients after surgery in both arms.

NCT ID: NCT05375825 Withdrawn - Clinical trials for Epithelial Tumors, Malignant

Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin

Start date: January 31, 2024
Phase: Phase 1
Study type: Interventional

Background: Cancers that spread into the thin tissue lining your lungs (pleura) cause serious illness. They often recur when removed. These tumors include malignant pleural mesothelioma (MPM), caused by exposure to asbestos and related fibers. Malignant pleural effusions (MPEs) are caused when cancers in other parts of the body spread to the lungs and pleura. Many people diagnosed with pleural tumors survive less than a year. Objective: To test the safety of a study drug (LMB-100) in people. LMB-100 may help stop pleural tumors from recurring after surgery. Eligibility: People aged 18 years or older diagnosed with MPM or related cancer that has spread into the pleura. Design: Participants will undergo screening. They will have a physical exam with blood and urine tests. They will have CT scans. They will have tests that measure the how their heart and lungs function. They will provide a sample of tumor tissue to determine if their tumor expresses a protein called mesothelin. Participants will undergo standard surgery to maximally remove the plural tumors. Then they will have LMB-100 pumped into their chest. The liquid will rinse the chest wall, diaphragm, heart sac, and surface of the lungs for 90 minutes. Then the liquid will be drained and the surgical incisions closed. The participants will be under anesthesia during this procedure. Participants will remain in the intensive care unit for a least 48 hours. They will remain in the hospital for up to a week or more until recovered enough to be safely discharged. Participants will return for regular follow-up visits for 2 years.

NCT ID: NCT05337735 Suspended - Clinical trials for Small Cell Lung Cancer

A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers

Start date: August 5, 2022
Phase: Phase 2
Study type: Interventional

To test the safety of and effectiveness of XmAb20717 for participants with advanced rare cancers.

NCT ID: NCT05324436 Recruiting - Clinical trials for Mesothelioma, Malignant

A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)

Start date: January 8, 2022
Phase:
Study type: Observational

The purpose of this study is to observe the safety of the combination therapy with Yervoy and Opdivo in Japanese participants for the treatment of unresectable advanced/recurrent malignant pleural mesothelioma (MPM).

NCT ID: NCT05308966 Active, not recruiting - Clinical trials for Malignant Pleural Mesothelioma

Observational Study in Patients With Previously Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab (MESO-IMMUNE)

MESO-IMMUNE
Start date: May 3, 2022
Phase:
Study type: Observational

Meso-Immune is a retrospective study to assess the efficacy and safety of the combination of Nivolumab and Ipilimumab used in first-line treatment of adult patients with unresectable Malignant Pleural Mesothelioma (MPM). This combination of treatments has been approved in Europe since June 2021 based on the results of the CheckMate 743 study. In France, the combination is not yet reimbursed for this population of patients. However, since April 01, 2021, newly diagnosed unresectable MPM patients may be treated with this combination via an early access program. Meso-Immune study targets these patients included in the early access program with the objective to provide additional results to the CheckMate 743 study and confirm the benefit of using this combination in first-line of treatment in this category of patients. Total study duration will cover 48 months with an inclusion period of 12 months and a follow-up until 3 years. Patients will be recruited retrospectively starting April 01, 2021 until April 01, 2022. Meso-Immune study will be proposed to all the GFPC centers that have already included patients in the early access program and other centers wishing to participate, in order to analyze a minimum of 150 patients. The total number of sites is evaluated at around 120. The principal investigator in each center will identify the patients eligible for the Meso-Immune study and will inform them on the study according to the local regulations. Patient follow-up will be pursued regularly, in in-patient and out-patient clinics, according to the usual practices of the physicians in each participating center. Reevaluation workups will be pursued according to the practices of each center. The information related to Patient characteristics, MPM characteristics, Treatment characteristics, Disease progression, Rebiopsy, Post treatments, Adverse events, Date and cause of death, Date of last news will be recorded in electronic case-report forms (eCRF). Qualitative variables will be presented descriptively in the principal analysis.

NCT ID: NCT05304208 Recruiting - Clinical trials for Mesotheliomas Pleural

dENdritic Cell Therapy Combined With SURgEry in Mesothelioma

ENSURE
Start date: November 2, 2021
Phase: Phase 1
Study type: Interventional

The ENSURE trial is an open label, single center, phase 1, feasibility study. Sixteen adult patients diagnosed with resectable epithelioid malignant pleural mesothelioma (MPM) will be enrolled following first-line chemotherapy. Before standard-of-care chemotherapy, a leukapheresis will be performed and monocytes will be used for differentiation to dendritic cells (DCs) using specific cytokines. Allogeneic tumor lysate (Pheralys) loaded autologous DCs (MesoPher) will be re-injected 3 weeks after completing chemotherapy, 2 times every other week. Four weeks after the first injection with dendritic cell therapy (DCT), patients will undergo extrapleural pleurectomy/decortication (eP/D) surgery and receive three bi-weekly injections with DCT (starting 4 weeks after surgery). In total, five DC vaccinations will be administered. A tumor biopsy will be collected before starting neo-adjuvant DCT.