Primary Outcome Measures Phase 1 – Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events. [ Time Frame: DLTs within 28 days post-treatment ] Phase 1 -The number and percent of patients in the DLT evaluable set who experienced DLTs from the first administration of study drug[…]
Recruiting
Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma (INTERACT MESO)
Primary Outcome Measures The maximum tolerable dose (MTD) [ Time Frame: After two completed cycles of therapy (each cycle is 1 week) ] The primary endpoint of the study is to determine the maximum tolerable dose (MTD) of intraperitoneal (IP) paclitaxel monotherapy, for patients with malignant peritoneal mesothelioma (MPM) who are not eligible to[…]
— SMARTEST Trial—
Primary Outcome Measures CD8 TILs density / gross tumor volume (GTV) [ Time Frame: Up to five years ] The primary objective of the study is to demonstrate that low dose cyclophosphamide in combination with sub-ablative radiation can enhance the anti-tumoral immune response compared to sub-ablative radiation alone Secondary Outcome Measures Survival [ Time Frame: Up to[…]
A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)
Primary Outcome Measures Incidence of Adverse Events (AEs) [ Time Frame: Up to 6 Months ] Time to onset of serious adverse events (SAEs) [ Time Frame: Up to 6 Months ] Time to onset of AEs [ Time Frame: Up to 6 Months ] Time to resolution of AEs [ Time Frame: Up to 6 Months ] Time to resolution of SAEs [ Time Frame: Up to 6[…]
DENDRITIC Cell Therapy Combined With SURGERY in Mesothelioma (ENSURE)
Primary Outcome Measures Number of participant who are alive and have completed (neo)adjuvant DCT (5 administrations) and surgery at week 15 (+4 weeks) without extended treatment-related delay, persisting grade 3-4 treatment side-effects or evidence of progression [Feasibility] [ Time Frame: 2 years ] To determine the feasibility of DCT with Mesopher performed before and[…]
Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma
Primary Outcome Measures Dose-limiting Toxicity [ Time Frame: First 21 days of treatment. ] The incidence of DLTs during the DLT assessment period. Frequency and Severity of Adverse Events (AE) [ Time Frame: Screening to 90 days from last dose. ] The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by[…]
Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects With Advanced Solid Tumors
Primary Outcome Measures Safety and tolerability of IK-930 [ Time Frame: Through study completion, an average of 36 months ] The frequency and severity, incidence of treatment-emergent and treatment-related adverse events using NCI-CTCAE v5.0 Occurrence of Dose Limiting Toxicity during first treatment cycle [ Time Frame: Approximately 1 year ] RP2D and/or MTD of IK-930 [ Time Frame: Approximately 1 year ][…]
Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Primary Outcome Measures Phase 1: Number of Patients who Experience Dose-Limiting Toxicity [ Time Frame: 21 days ] Phase 1/1B: Number of patients who experience a treatment-related adverse event [ Time Frame: Up to 2 years ] Phase 2: Objective response rate (ORR) [ Time Frame: 2 years ] Phase 2: Duration of response (DOR) [ Time Frame: 2 years ] Phase 2: Progression free survival[…]
Glypican-1 Expression in Epithelioid Mesothelioma, Adenocarcinoma and SCC of the Lung
Primary outcome Measures evaluate the immunohistochemical expression of Glypican-1 in pleural epitheloid mesothelioma, lung adenocarcinoma and lung SCC [ Time Frame: 1 month ] Immunohistochemical study to correlate its expression with some known clinico-pathological parameters, to evaluate its diagnostic and prognostic role. [ Time Frame: 1 month ] Statistical analysis Inclusion Criteria Patients with pleural epithelioid mesothelioma and[…]
ERAS® Guidelines Validation of CRS With or Without HIPEC
Primary Outcome Measures Compliance of ERAS® guidelines [ Time Frame: 3 months ] Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines Secondary Outcome Measures Acceptance and feasibility of ERAS® guidelines [ Time Frame: 3 months ] Pre-ERAS® phase (current clinical practice): current compliance rate towards the ERAS guidelines Inclusion Criteria Adults female and[…]
