Combination of Induction Durvalumab and Tremelimumab Alone Versus Durvalumab and Tremelimumab With Chemotherapy for Potentially Resectable Pleural Mesothelioma
Objectives: The investigators will test whether combination of chemoimmunotherapy or dual agent immunotherapy alone improves efficacy for patients with MPM. Primary Objectives: The primary objective is to test whether the combination of platinum-based chemotherapy and pemetrexed with durvalumab / tremelimumab or durvalumab / tremelimumab alone improves recurrence-free survival for patients with resectable MPM compared to historical, published data for surgery with chemotherapy. Secondary Objective(s): The secondary objectives are to determine the safety of and whether the platinum-based chemotherapy and pemetrexed with durvalumab / tremelimumab or durvalumab / tremelimumab alone improves response rate, resectability, major pathological response, and complete pathological response. Exploratory Objective(s): The exploratory objectives are to determine the safety of and whether the platinum-based chemotherapy and pemetrexed with durvalumab / tremelimumab or durvalumab / tremelimumab alone improves response rate, resectability, major pathological response, and complete pathological response for patients with epithelioid and non-epithelioid histologies. The scientific exploratory objectives include: 1. Develop an NGS plasma assay of common mutations identified from our previous grant cycle to prospectively measure minimal residual disease (MRD) after resection as a potential, novel biomarker test in mesothelioma. 2. Determine the predictive role of BH3 profiling in patients undergoing neoadjuvant ICI followed by surgery: With patient samples collected from our neoadjuvant ICI trial, the investigators will test whether BH3 profiling from pre-treatment tumor biopsies and PBMC predicts clinical, radiological, and pathological responses to ICIs. The investigators will identify TAMs from the TiME in MPM tumor samples before and after treatment to compare differences in polarization induced by ICI in clinical and pathologically responding versus non-responding patients.
NCT05932199 — Mesothelioma
Status: Not yet recruiting
http://inclinicaltrials.com/mesothelioma/NCT05932199/
Switch-Maintenance Gemcitabine After First-Line Chemotherapy (Pemetrexed-Platinum) In Patients With Malignant Pleural Mesothelioma In Ain Shams University Hospitals
Mesothelioma is an aggressive form of cancer. Treatments are available, but for many people, a cure isn't possible. This thesis is to assess the efficacy and safety of switch-maintenance Gemcitabine in Mesothelioma patients after first line chemotherapy (Pemetrexed-Platinum)
NCT05660616 — Malignant Pleural Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT05660616/
Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
NCT05655078 — Malignant Pleural Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT05655078/
Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma
This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.
NCT05647265 — Pleural Biphasic Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/pleural-biphasic-mesothelioma/NCT05647265/
A Phase 1 Study of SynKIR-110, Autologous T Cells Transduced With Mesothelin KIR-CAR, in Subjects With Mesothelin-Expressing Advanced Ovarian Cancer, Cholangiocarcinoma, or Mesothelioma
This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma.
NCT05568680 — Ovarian Cancer
Status: Recruiting
http://inclinicaltrials.com/ovarian-cancer/NCT05568680/
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study
The purpose of this post-authorisation medical device study is to obtain real life data on the use of Tumor Treating Fields (TTFields) in patients with pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.
NCT05538806 — Pleural Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/pleural-mesothelioma/NCT05538806/
Effect of Intraoperative Hyperthermic Intrathoracic Chemotherapy After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma.
Malignant pleural mesothelioma (MPM) is an aggressive malignancy of the pleural lining with exceptionally poor survival. Median survival from diagnosis is less than 12 months (1). The widespread use of asbestos in past decades together with the long latency of MPM are responsible for the still increasing incidence of MPM (2), affecting 7-40 people per million inhabitants depending on the geographic region (3). The main therapeutic strategies for MPM are surgery, chemotherapy, and radiation therapy (RT). Multimodality treatment for MPM is a topic that has been attracting a lot of attention from researchers, as therapeutic modalities such as surgery, chemotherapy, or radiotherapy have not proven to be effective as single-modality treatments (4). surgery alone is not able to achieve microscopic complete (R0) resection. Therefore, combined treatment modalities have been established in many centres during the last years to achieve a better local tumor control with increasing overall survival (5). In this regard, hyperthermic intrathoracic or intrapleural chemotherapy has been used as one of the multimodality therapies. Intrapleural injection of cytotoxic drugs with hyperthermic perfusion has been proved to enhance cytotoxic effect on tumor cells with limited systemic side effect (6). While cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) has become a standard therapy for intraperitoneal original carcinoma or carcinomatosis peritonei such as pseudomyxoma and colorectal cancer induced ascites (7), limited studies have been reported on the application of hyperthermic intrathoracic chemotherapy (HITHOC) in combination with cytoreductive surgery for the treatment of the malignant pleural mesothelioma (8). With the application of the HITOC after macroscopic complete pleural tumour resection, it is expected to obtain better local tumour control, and thereby improve progression-free as well as overall survival (9). In this study, we aim to compare results of HITHOC after P/D versus P/D alone in managing patients with localised MPM and our main outcomes are disease free survival, overall survival and possible perioperative complications.
NCT05508555 — Chemotherapy Effect
Status: Recruiting
http://inclinicaltrials.com/chemotherapy-effect/NCT05508555/
Niraparib Efficacy in Patient With Unresectable Mesothelioma: A Randomised Phase II Trial of Niraparib Versus Active Symptom Control in Patients With Previously Treated Mesothelioma
Multicentre, 2 arm, open-label UK randomised phase II trial to determine the efficacy of niraparib versus active symptom control (ASC) in patients who have relapsed after previously receiving platinum based systemic therapy. 84 patients will be recruited from approximately 10 UK trial network sites.
NCT05455424 — Mesothelioma, Malignant
Status: Active, not recruiting
http://inclinicaltrials.com/mesothelioma-malignant/NCT05455424/
Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma - a Phase I/II Dose Escalation and Safety Study
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.
NCT05449366 — Peritoneal Malignant Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/peritoneal-malignant-mesothelioma/NCT05449366/
Surgery for Mesothelioma After Radiation Therapy Using Exquisite Systemic Therapy
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.
NCT05380713 — Mesothelioma, Malignant
Status: Recruiting
http://inclinicaltrials.com/mesothelioma-malignant/NCT05380713/